<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03029208</url>
  </required_header>
  <id_info>
    <org_study_id>201410</org_study_id>
    <secondary_id>2016-000507-86</secondary_id>
    <nct_id>NCT03029208</nct_id>
  </id_info>
  <brief_title>Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)</brief_title>
  <official_title>A 52-week Open-label (Sponsor-blind), Randomized, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Efficacy and Safety of Daprodustat Compared to Recombinant Human Erythropoietin in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Initiating Dialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat&#xD;
      in subjects with anemia associated with CKD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 11, 2017</start_date>
  <completion_date type="Actual">September 24, 2020</completion_date>
  <primary_completion_date type="Actual">September 24, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52)</measure>
    <time_frame>Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)</time_frame>
    <description>Blood samples were collected from participants for Hgb measurement. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputations. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. An analysis of covariance (ANCOVA) model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95 percent (%) confidence interval (CI) for the treatment difference (daprodustat-darbepoetin alfa).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52</measure>
    <time_frame>Baseline (Day 1) to Week 52</time_frame>
    <description>Total IV iron dose per participant was calculated from Day 1 to the earliest of (Week 52 visit date, first blood [red blood cells or whole blood] transfusion date and treatment stop date plus [+] 1 day) which corresponds to the time while the participant was on randomized treatment and before receiving a blood transfusion. Average monthly IV iron dose was calculated by Total IV iron dose divided by (/) (the number of days from Day 1 to the earliest of [Week 52 visit date, first blood transfusion date and treatment stop date +1] /30.4375 days). Data for participants until they underwent a red blood cells or whole blood transfusion was included in the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52</measure>
    <time_frame>Baseline (Day 1) and Week 52</time_frame>
    <description>SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using mixed model repeated measures (MMRM) model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SBP, DBP, MAP at End of Treatment</measure>
    <time_frame>Baseline (Day 1) and end of treatment (last on-treatment value until Week 52)</time_frame>
    <description>SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. End of treatment value for the blood pressure parameters were defined as the latest value on or before the last non-zero dose date plus (+) 1 day. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using ANCOVA model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure (BP) Exacerbation Events Rate Per 100 Participant Years</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>BP exacerbation event is defined (based on post-dialysis BP) as SBP &gt;=25 millimeter of mercury (mmHg) increased from Baseline or SBP &gt;=180 mmHg; or DBP &gt;=15 mmHg increased from Baseline or DBP &gt;=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the Negative Binomial Model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least One Blood Pressure Exacerbation Event During Study</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>BP exacerbation was defined (based on post-dialysis BP) as: SBP &gt;=25 mmHg increased from Baseline or SBP &gt;=180 mmHg; DBP &gt;=15 mmHg increased from Baseline or DBP &gt;=110 mmHg. Number of participants with at least one blood pressure exacerbation event is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Post-randomization Hgb at Week 52</measure>
    <time_frame>Baseline (Day 1) and Week 52</time_frame>
    <description>Blood samples were collected from participants for Hgb measurements. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52)</measure>
    <time_frame>Weeks 28 to 52</time_frame>
    <description>Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as number of participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis</measure>
    <time_frame>Weeks 28 to 52</time_frame>
    <description>Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Superiority Analysis</measure>
    <time_frame>Weeks 28 to 52</time_frame>
    <description>Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Number of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52</measure>
    <time_frame>Baseline (Day 1), Weeks 8, 12, 28 and 52</time_frame>
    <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52</measure>
    <time_frame>Baseline (Day 1), Weeks 8, 12, 28 and 52</time_frame>
    <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52</measure>
    <time_frame>Baseline (Day 1), Weeks 8, 12, 28 and 52</time_frame>
    <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain, general health, mental health, role-emotional (role limitations caused by emotional problems), role-physical (role limitations caused by physical problems), social functioning, physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52</measure>
    <time_frame>Baseline (Day 1), Weeks 28 and 52</time_frame>
    <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52</measure>
    <time_frame>Baseline (Day 1), Weeks 28 and 52</time_frame>
    <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52</measure>
    <time_frame>Baseline (Day 1) and Week 52</time_frame>
    <description>EQ-5D-5L consists of 2 concepts-EQ-5D-5L descriptive system and EQ Visual Analogue Scale (EQ-VAS). EQ-5D-5L is self-assessment questionnaire, consisting of 5items covering 5 dimensions (mobility,self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale(no problems, slight problems, moderate problems, severe problems and extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state(e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health), higher the score better the health status. Change from Baseline was calculated as post-dose visit value-Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EQ Visual Analogue Scale (EQ-VAS) at Week 52</measure>
    <time_frame>Baseline (Day 1) and Week 52</time_frame>
    <description>The EQ-5D-5L consists of 2 concepts -EQ-5D-5L descriptive system and EQ-VAS. The EQ-5D-5L is a self-assessment questionnaire, consisting of five items covering five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by a five-point Likert scale (no problems, slight problems, moderate problems, severe problems, and extreme problems). The range for the EQ-5D-5L index score is 0 to 1 with '0' is worst health and '1' is full health. The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst health one can imagine and 100 represents the best health one can imagine. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52</measure>
    <time_frame>Baseline (Day 1) and Week 52</time_frame>
    <description>CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy/Weak scale consisting of 10 items; 2.Chest Pain/Shortness of Breath scale consisting of 4 items; and 3.Cognitive scale consisting of 3 items. The 4 CKD-AQ single items are: (shortness of breath, no activity), (severity-short breath, resting), (difficulty standing for long time) and (difficulty sleeping). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient Global Impression of Severity (PGI-S)</measure>
    <time_frame>Baseline (Day 1), Weeks 8, 12, 28 and 52</time_frame>
    <description>The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated worse outcome. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)</measure>
    <time_frame>Pre-dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12</time_frame>
    <description>Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic (PK) analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. Pharmacokinetic Population comprised of participants for whom a pharmacokinetic sample was obtained and analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)</measure>
    <time_frame>Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12</time_frame>
    <description>Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)</measure>
    <time_frame>Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12</time_frame>
    <description>Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">312</enrollment>
  <condition>Anaemia</condition>
  <arm_group>
    <arm_group_label>Daprodustat treated anemic subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive oral daprodustat once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Darbepoetin alfa treated anemic subjects</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive darbepoetin alfa subcutaneously or intravenously.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daprodustat</intervention_name>
    <description>Daprodustat will be supplied as film coated tablets for oral administration containing 1, 2, 4, 6, 8, or 10 mg of daprodustat. Doses of 12, 16, and 24 mg of daprodustat will be provided using multiples of these tablet strengths.</description>
    <arm_group_label>Daprodustat treated anemic subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Darbepoetin alfa</intervention_name>
    <description>Darbepoetin alfa will be supplied as prefilled syringes (PFS) for SC/IV injection available in strengths: 20, 30, 40, 60, 80, 100 and 150 mcg.</description>
    <arm_group_label>Darbepoetin alfa treated anemic subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iron therapy</intervention_name>
    <description>Iron therapy will be administered if ferritin is &lt;=100 ng/mL and/or TSAT is &lt;=20%.</description>
    <arm_group_label>Daprodustat treated anemic subjects</arm_group_label>
    <arm_group_label>Darbepoetin alfa treated anemic subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 99 years of age inclusive.&#xD;
&#xD;
          -  Planning to start chronic dialysis within the next 6 weeks (from the date of the&#xD;
             screening visit) OR have started and received dialysis (as specified below) for&#xD;
             end-stage renal disease for a maximum of &lt;=90 days immediately prior to randomization&#xD;
             and is not expected to stop dialysis during the duration of the trial: HD &gt;=2 times&#xD;
             per week or PD &gt;=4 times per week including incremental schedule; subjects on&#xD;
             continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis&#xD;
             (APD) are eligible.&#xD;
&#xD;
          -  Hemoglobin concentration as measured by HemoCue (range inclusive): 8 to 10.5 g/dL&#xD;
             (5-6.5 millimoles per liter [mmol/L]) at screening and 8-11.0 g/dL (5 to 6.8 mmol/L)&#xD;
             at randomization.&#xD;
&#xD;
          -  Capable of giving signed informed consent which includes compliance with the&#xD;
             requirements and restrictions listed in the consent form and in this protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planned living-related or living-unrelated kidney transplant during the study.&#xD;
&#xD;
          -  Ferritin: &lt;=100 nanograms per milliliter (ng/mL) (&lt;=100 micrograms per liter [mcg/L])&#xD;
             at screening or after IV iron supplementation.&#xD;
&#xD;
          -  Transferrin saturation (TSAT): &lt;=20% at screening or after IV iron supplementation.&#xD;
&#xD;
          -  Vitamin B12 (cobalamin): Below the lower limit of the reference range at screening or&#xD;
             after vitamin B12 supplementation.&#xD;
&#xD;
          -  Folate: &lt;2.0 ng/mL (&lt;4.5 nanomoles per liter [nmol/L]) at screening.&#xD;
&#xD;
          -  Aplasias: History of bone marrow aplasia or pure red cell aplasia (PRCA).&#xD;
&#xD;
          -  Other causes of anemia: Untreated pernicious anemia, thalassemia major, sickle cell&#xD;
             disease, or myelodysplastic syndrome.&#xD;
&#xD;
          -  Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or&#xD;
             esophageal ulcer disease or clinically significant GI bleeding &lt;=10 weeks prior to&#xD;
             screening through to randomization (Day 1).&#xD;
&#xD;
          -  Use of any Erythropoiesis-stimulating agent (ESA) treatment within 8 weeks prior to&#xD;
             screening except for limited use as part of dialysis initiation. Note : Limited use is&#xD;
             defined as no more than 6 weeks of short acting ESA (rhEPO or biosimilars; maximum of&#xD;
             20000 unit total) or long acting ESA (darbepoetin alfa [maximum of 100 mcg total] or&#xD;
             methoxy polyethylene glycol-epoetin beta [maximum of 125 mcg total]) received before&#xD;
             or after starting dialysis.&#xD;
&#xD;
          -  Myocardial infarction or acute coronary syndrome: &lt;=10 weeks prior to screening&#xD;
             through to randomization (Day 1).&#xD;
&#xD;
          -  Stroke or transient ischemic attack: &lt;=10 weeks prior to screening through to&#xD;
             randomization (Day 1).&#xD;
&#xD;
          -  Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA)&#xD;
             functional classification system.&#xD;
&#xD;
          -  Current uncontrolled hypertension as determined by the Investigator that would&#xD;
             contraindicate the use of rhEPO.&#xD;
&#xD;
          -  QT correction using Bazett's (QTcB) (Day 1): QTcB &gt;500 milliseconds (msec), or QTcB&#xD;
             &gt;530 msec in subjects with bundle branch block. There is no QTc exclusion for subjects&#xD;
             with a predominantly ventricular paced rhythm.&#xD;
&#xD;
          -  Liver disease (any one of the following): 1. Alanine transaminase (ALT) &gt;2 times upper&#xD;
             limit of normal (ULN) (screening only). 2. Bilirubin &gt;1.5 times ULN (screening only)&#xD;
             (NOTE: Isolated bilirubin &gt;1.5 times ULN is acceptable if bilirubin is fractionated&#xD;
             and direct bilirubin &lt;35%). 3. Current unstable liver or biliary disease per&#xD;
             investigator assessment, generally defined by the presence of ascites, encephalopathy,&#xD;
             coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or&#xD;
             cirrhosis. NOTE: Stable chronic liver disease (including asymptomatic gallstones,&#xD;
             chronic hepatitis B or C, or Gilbert's syndrome) are acceptable if subject otherwise&#xD;
             meets entry criteria.&#xD;
&#xD;
          -  History of malignancy within the 2 years prior to screening through to randomization&#xD;
             (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (i.e.&#xD;
             Bosniak Category II F, III or IV) &gt;3 centimeter (cm). The only exception is localized&#xD;
             squamous cell or basal cell carcinoma of the skin that has been definitively treated&#xD;
             &gt;=10 weeks prior to screening.&#xD;
&#xD;
          -  History of severe allergic or anaphylactic reactions or hypersensitivity to excipients&#xD;
             in the investigational product or to darbepoetin alfa.&#xD;
&#xD;
          -  Use of strong Cytochrome P4502C8 (CYP2C8) inhibitors (example gemfibrozil) or strong&#xD;
             CYP2C8 inducers (example rifampin/rifampicin).&#xD;
&#xD;
          -  Use of other investigational agent or device prior to screening through to&#xD;
             randomization (Day 1). At screening, this exclusion applies to use of the&#xD;
             investigational agent within 30 days or within five half-lives (whichever is longer).&#xD;
&#xD;
          -  Any prior treatment with daprodustat for treatment duration of &gt;30 days.&#xD;
&#xD;
          -  Females only: Subject is pregnant [as confirmed by a positive serum human chorionic&#xD;
             gonadotropin (hCG) test for females of reproductive potential (FRP) only], subject is&#xD;
             breastfeeding, or subject is of reproductive potential and does not agree to follow&#xD;
             one of the contraceptive options in the List of Highly Effective Methods for Avoiding&#xD;
             Pregnancy.&#xD;
&#xD;
          -  Any other condition, clinical or laboratory abnormality, or examination finding that&#xD;
             the investigator considers would put the subject at unacceptable risk, which may&#xD;
             affect study compliance (example intolerance to rhEPO) or prevent understanding of the&#xD;
             aims or investigational procedures or possible consequences of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cerritos</city>
        <state>California</state>
        <zip>90703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <zip>92025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>La Palma</city>
        <state>California</state>
        <zip>90623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lynwood</city>
        <state>California</state>
        <zip>90262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Middlebury</city>
        <state>Connecticut</state>
        <zip>06762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Crystal Lake</city>
        <state>Illinois</state>
        <zip>60014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Merrillville</city>
        <state>Indiana</state>
        <zip>46410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Michigan City</city>
        <state>Indiana</state>
        <zip>46360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lufkin</city>
        <state>Texas</state>
        <zip>75904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hampton</city>
        <state>Virginia</state>
        <zip>23666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Evita</city>
        <state>Buenos Aires</state>
        <zip>B1778IFA</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>La Plata</city>
        <state>Buenos Aires</state>
        <zip>B1902COS</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Morón</city>
        <state>Buenos Aires</state>
        <zip>B1708DPO</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pergamino</city>
        <state>Buenos Aires</state>
        <zip>B2700CPM</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pilar</city>
        <state>Buenos Aires</state>
        <zip>1629</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1425</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Formosa</city>
        <zip>P3600LLD</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mendoza</city>
        <zip>M5500AFA</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Miguel de Tucumán</city>
        <zip>T4000AHL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St Albans</city>
        <state>Victoria</state>
        <zip>3021</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M3M 0B2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <zip>J4V 2H1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Duesseldorf</city>
        <state>Nordrhein-Westfalen</state>
        <zip>40210</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kaiserslautern</city>
        <state>Rheinland-Pfalz</state>
        <zip>67655</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wiesbaden</city>
        <zip>65191</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bangalore</city>
        <zip>560055</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chennai</city>
        <zip>600037</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Delhi</city>
        <zip>110076</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gurgaon</city>
        <zip>122001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kozhikode</city>
        <zip>673008</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>New Delhi</city>
        <zip>110060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pune</city>
        <zip>411004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Secunderabad</city>
        <zip>560020</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Thiruvananthapuram</city>
        <zip>695011</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Genova</city>
        <state>Liguria</state>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20153</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pavia</city>
        <state>Lombardia</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cagliari</city>
        <state>Sardegna</state>
        <zip>09100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Anyang-Si, Gyeonggi-do</city>
        <zip>14068</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucheon-si,</city>
        <zip>14647</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Incheon</city>
        <zip>6510</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>05030</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Suwon</city>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ipoh</city>
        <zip>30450</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Penang</city>
        <zip>10990</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Torreon</city>
        <state>Coahuila</state>
        <zip>27000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad De México</city>
        <state>Estado De México</state>
        <zip>14000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Guadalajara.</city>
        <state>Jalisco</state>
        <zip>44600</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zapopan</city>
        <state>Jalisco</state>
        <zip>45030</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Merida</city>
        <state>Yucatán</state>
        <zip>CP 97070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mérida</city>
        <state>Yucatán</state>
        <zip>97130</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aguascalientes</city>
        <zip>20259</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tlalnepantla</city>
        <zip>54055</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kolo</city>
        <zip>62-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Krakow</city>
        <zip>31-826</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lodz</city>
        <zip>92-213</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lodz</city>
        <zip>96-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ostroda</city>
        <zip>14-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ostroleka</city>
        <zip>7410</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Szczecin</city>
        <zip>70-780</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Irkutsk</city>
        <zip>664049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mytishchi</city>
        <zip>141007</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Omsk</city>
        <zip>644112</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Smolensk</city>
        <zip>214006</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St-Petersburg</city>
        <zip>197110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>191104</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194354</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>196247</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Volzhskiy</city>
        <zip>404120</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cape Town.</city>
        <zip>7925</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Puerto Real</city>
        <zip>11510</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Doncaster</city>
        <zip>DN2 5LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Middlesbrough</city>
        <zip>TS4 3BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>India</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <results_first_submitted>September 22, 2021</results_first_submitted>
  <results_first_submitted_qc>September 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 20, 2021</results_first_posted>
  <last_update_submitted>September 22, 2021</last_update_submitted>
  <last_update_submitted_qc>September 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Daprodustat, recombinant human erythropoietin, darbepoetin, anemia, chronic kidney disease, dialysis, ESRD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Darbepoetin alfa</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>http://clinicalstudydatarequest.com</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03029208/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT03029208/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a multicenter study conducted across 14 countries. Participants were randomized to receive either Daprodustat or Darbepoetin alfa.</recruitment_details>
      <pre_assignment_details>A total of 312 participants were randomized in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Daprodustat</title>
          <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
        </group>
        <group group_id="P2">
          <title>Darbepoetin Alfa</title>
          <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="157"/>
                <participants group_id="P2" count="155"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="155"/>
                <participants group_id="P2" count="151"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Daprodustat</title>
          <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
        </group>
        <group group_id="B2">
          <title>Darbepoetin Alfa</title>
          <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="157"/>
            <count group_id="B2" value="155"/>
            <count group_id="B3" value="312"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.7" spread="14.31"/>
                    <measurement group_id="B2" value="55.8" spread="15.70"/>
                    <measurement group_id="B3" value="54.7" spread="15.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian (AI) or Alaskan Native (AN)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian: Central/South Asian Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian: East Asian Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian: South East Asian Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White: Arabic/North African Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White: White/Caucasian/European Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="216"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mixed race: AI or AN and White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52)</title>
        <description>Blood samples were collected from participants for Hgb measurement. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputations. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. An analysis of covariance (ANCOVA) model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95 percent (%) confidence interval (CI) for the treatment difference (daprodustat-darbepoetin alfa).</description>
        <time_frame>Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)</time_frame>
        <population>Intent-to-Treat (ITT) Population comprised all randomized participants (who received a treatment randomization number).</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52)</title>
          <description>Blood samples were collected from participants for Hgb measurement. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputations. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. An analysis of covariance (ANCOVA) model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95 percent (%) confidence interval (CI) for the treatment difference (daprodustat-darbepoetin alfa).</description>
          <population>Intent-to-Treat (ITT) Population comprised all randomized participants (who received a treatment randomization number).</population>
          <units>Grams per deciliter</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" spread="0.086"/>
                    <measurement group_id="O2" value="1.12" spread="0.085"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.</non_inferiority_desc>
            <param_type>Least square (LS) mean difference</param_type>
            <param_value>-0.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.34</ci_lower_limit>
            <ci_upper_limit>0.14</ci_upper_limit>
            <estimate_desc>An ANCOVA model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95% CI for the treatment difference (daprodustat-darbepoetin alfa).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52</title>
        <description>Total IV iron dose per participant was calculated from Day 1 to the earliest of (Week 52 visit date, first blood [red blood cells or whole blood] transfusion date and treatment stop date plus [+] 1 day) which corresponds to the time while the participant was on randomized treatment and before receiving a blood transfusion. Average monthly IV iron dose was calculated by Total IV iron dose divided by (/) (the number of days from Day 1 to the earliest of [Week 52 visit date, first blood transfusion date and treatment stop date +1] /30.4375 days). Data for participants until they underwent a red blood cells or whole blood transfusion was included in the analysis.</description>
        <time_frame>Baseline (Day 1) to Week 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52</title>
          <description>Total IV iron dose per participant was calculated from Day 1 to the earliest of (Week 52 visit date, first blood [red blood cells or whole blood] transfusion date and treatment stop date plus [+] 1 day) which corresponds to the time while the participant was on randomized treatment and before receiving a blood transfusion. Average monthly IV iron dose was calculated by Total IV iron dose divided by (/) (the number of days from Day 1 to the earliest of [Week 52 visit date, first blood transfusion date and treatment stop date +1] /30.4375 days). Data for participants until they underwent a red blood cells or whole blood transfusion was included in the analysis.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Milligram</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="156"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144.7" spread="10.90"/>
                    <measurement group_id="O2" value="125.3" spread="10.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8949</p_value>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>19.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.0</ci_lower_limit>
            <ci_upper_limit>49.9</ci_upper_limit>
            <estimate_desc>An ANCOVA model was used to compare the difference in this average monthly IV iron dose between arms, including factors for Baseline dose, treatment and the randomization stratification factors.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52</title>
        <description>SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using mixed model repeated measures (MMRM) model.</description>
        <time_frame>Baseline (Day 1) and Week 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52</title>
          <description>SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using mixed model repeated measures (MMRM) model.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Millimeter of mercury</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.57" spread="2.063"/>
                    <measurement group_id="O2" value="-6.80" spread="2.931"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="1.216"/>
                    <measurement group_id="O2" value="-4.01" spread="1.650"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MAP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.95" spread="1.364"/>
                    <measurement group_id="O2" value="-5.05" spread="1.894"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8168</p_value>
            <method>Mixed model repeated measures (MMRM)</method>
            <param_type>LS mean difference</param_type>
            <param_value>3.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.82</ci_lower_limit>
            <ci_upper_limit>10.27</ci_upper_limit>
            <estimate_desc>The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9793</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>4.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.17</ci_lower_limit>
            <ci_upper_limit>8.26</ci_upper_limit>
            <estimate_desc>The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9597</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>4.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.51</ci_lower_limit>
            <ci_upper_limit>8.70</ci_upper_limit>
            <estimate_desc>The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in SBP, DBP, MAP at End of Treatment</title>
        <description>SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. End of treatment value for the blood pressure parameters were defined as the latest value on or before the last non-zero dose date plus (+) 1 day. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using ANCOVA model.</description>
        <time_frame>Baseline (Day 1) and end of treatment (last on-treatment value until Week 52)</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SBP, DBP, MAP at End of Treatment</title>
          <description>SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. End of treatment value for the blood pressure parameters were defined as the latest value on or before the last non-zero dose date plus (+) 1 day. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using ANCOVA model.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Millimeter of mercury</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="154"/>
                <count group_id="O2" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.23" spread="1.659"/>
                    <measurement group_id="O2" value="-3.14" spread="1.664"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.60" spread="1.016"/>
                    <measurement group_id="O2" value="-1.39" spread="1.020"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MAP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.68" spread="1.092"/>
                    <measurement group_id="O2" value="-1.97" spread="1.096"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4840</p_value>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>-0.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.72</ci_lower_limit>
            <ci_upper_limit>4.53</ci_upper_limit>
            <estimate_desc>The difference in change from Baseline in SBP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9156</p_value>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>1.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.85</ci_lower_limit>
            <ci_upper_limit>4.82</ci_upper_limit>
            <estimate_desc>The difference in change from Baseline in DBP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7966</p_value>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>1.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.76</ci_lower_limit>
            <ci_upper_limit>4.33</ci_upper_limit>
            <estimate_desc>The difference in change from Baseline in MAP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blood Pressure (BP) Exacerbation Events Rate Per 100 Participant Years</title>
        <description>BP exacerbation event is defined (based on post-dialysis BP) as SBP &gt;=25 millimeter of mercury (mmHg) increased from Baseline or SBP &gt;=180 mmHg; or DBP &gt;=15 mmHg increased from Baseline or DBP &gt;=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the Negative Binomial Model.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Pressure (BP) Exacerbation Events Rate Per 100 Participant Years</title>
          <description>BP exacerbation event is defined (based on post-dialysis BP) as SBP &gt;=25 millimeter of mercury (mmHg) increased from Baseline or SBP &gt;=180 mmHg; or DBP &gt;=15 mmHg increased from Baseline or DBP &gt;=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the Negative Binomial Model.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Events per 100 participant year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="352.50" lower_limit="268.89" upper_limit="462.09"/>
                    <measurement group_id="O2" value="350.00" lower_limit="267.72" upper_limit="457.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5174</p_value>
            <method>Negative binomial model</method>
            <param_type>Ratio of exacerbation rate</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.39</ci_upper_limit>
            <estimate_desc>Model estimated exacerbation rates, ratio of model estimated exacerbation rates and CIs were estimated using a negative binomial model for the treatment group comparison.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least One Blood Pressure Exacerbation Event During Study</title>
        <description>BP exacerbation was defined (based on post-dialysis BP) as: SBP &gt;=25 mmHg increased from Baseline or SBP &gt;=180 mmHg; DBP &gt;=15 mmHg increased from Baseline or DBP &gt;=110 mmHg. Number of participants with at least one blood pressure exacerbation event is presented.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least One Blood Pressure Exacerbation Event During Study</title>
          <description>BP exacerbation was defined (based on post-dialysis BP) as: SBP &gt;=25 mmHg increased from Baseline or SBP &gt;=180 mmHg; DBP &gt;=15 mmHg increased from Baseline or DBP &gt;=110 mmHg. Number of participants with at least one blood pressure exacerbation event is presented.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Post-randomization Hgb at Week 52</title>
        <description>Blood samples were collected from participants for Hgb measurements. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
        <time_frame>Baseline (Day 1) and Week 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Post-randomization Hgb at Week 52</title>
          <description>Blood samples were collected from participants for Hgb measurements. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Grams per deciliter</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
                <count group_id="O2" value="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.17" spread="0.117"/>
                    <measurement group_id="O2" value="1.13" spread="0.115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.</non_inferiority_desc>
            <param_type>LS mean difference</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.29</ci_lower_limit>
            <ci_upper_limit>0.36</ci_upper_limit>
            <estimate_desc>The difference in change from Baseline in post-randomization Hgb at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52)</title>
        <description>Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as number of participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL.</description>
        <time_frame>Weeks 28 to 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52)</title>
          <description>Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as number of participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5411</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in response rate</param_type>
            <param_value>-0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.2</ci_lower_limit>
            <ci_upper_limit>10.7</ci_upper_limit>
            <estimate_desc>A Cochran-Mantel-Haenszel (CMH) test adjusted for treatment and randomization stratification factors were used to compare the number of responders between the treatment groups.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis</title>
        <description>Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'.</description>
        <time_frame>Weeks 28 to 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis</title>
          <description>Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Percentage of days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="128"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.0" lower_limit="0.0" upper_limit="100.0"/>
                    <measurement group_id="O2" value="54.7" lower_limit="0.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.</non_inferiority_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>2.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.45</ci_lower_limit>
            <ci_upper_limit>11.27</ci_upper_limit>
            <estimate_desc>Hodges-Lehmann Estimate of Treatment Difference has been reported.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Superiority Analysis</title>
        <description>Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'.</description>
        <time_frame>Weeks 28 to 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Superiority Analysis</title>
          <description>Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Percentage of days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="128"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.0" lower_limit="0.0" upper_limit="100.0"/>
                    <measurement group_id="O2" value="54.7" lower_limit="0.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1538</p_value>
            <method>van Elteren test</method>
            <param_type>Probability</param_type>
            <param_value>0.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>0.61</ci_upper_limit>
            <estimate_desc>Mann-Whitney estimate (Probability) of the treatment effect has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria</title>
        <description>Number of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria</title>
          <description>Number of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented.</description>
          <population>ITT Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.5348</p_value>
            <method>Wald test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.31</ci_lower_limit>
            <ci_upper_limit>3.66</ci_upper_limit>
            <estimate_desc>Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, dialysis type and dialysis start manner.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52</title>
        <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
        <time_frame>Baseline (Day 1), Weeks 8, 12, 28 and 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52</title>
          <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8, n=88,86</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.79" spread="0.648"/>
                    <measurement group_id="O2" value="1.18" spread="0.658"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, n=88,88</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.67" spread="0.627"/>
                    <measurement group_id="O2" value="0.54" spread="0.631"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28, n=80,74</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" spread="0.697"/>
                    <measurement group_id="O2" value="0.45" spread="0.725"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52, n=67,65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.61" spread="0.755"/>
                    <measurement group_id="O2" value="1.93" spread="0.774"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6641</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-0.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.22</ci_lower_limit>
            <ci_upper_limit>1.44</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1030</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>1.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.63</ci_lower_limit>
            <ci_upper_limit>2.89</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3157</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.51</ci_lower_limit>
            <ci_upper_limit>2.48</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8855</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.46</ci_lower_limit>
            <ci_upper_limit>0.84</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52</title>
        <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
        <time_frame>Baseline (Day 1), Weeks 8, 12, 28 and 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52</title>
          <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8, n=88,86</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.822"/>
                    <measurement group_id="O2" value="0.76" spread="0.839"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, n=88,88</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.813"/>
                    <measurement group_id="O2" value="1.60" spread="0.824"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28, n=80,74</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.905"/>
                    <measurement group_id="O2" value="0.30" spread="0.942"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52, n=67,65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.95" spread="1.029"/>
                    <measurement group_id="O2" value="-0.72" spread="1.051"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7146</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-0.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.99</ci_lower_limit>
            <ci_upper_limit>1.66</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9050</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.82</ci_lower_limit>
            <ci_upper_limit>0.76</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5950</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-0.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.91</ci_lower_limit>
            <ci_upper_limit>2.28</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5619</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.17</ci_lower_limit>
            <ci_upper_limit>2.70</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52</title>
        <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain, general health, mental health, role-emotional (role limitations caused by emotional problems), role-physical (role limitations caused by physical problems), social functioning, physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
        <time_frame>Baseline (Day 1), Weeks 8, 12, 28 and 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52</title>
          <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain, general health, mental health, role-emotional (role limitations caused by emotional problems), role-physical (role limitations caused by physical problems), social functioning, physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bodily pain: Week 8, n=88,86</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.41" spread="0.833"/>
                    <measurement group_id="O2" value="-0.55" spread="0.843"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodily pain: Week 12, n=88,88</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.892"/>
                    <measurement group_id="O2" value="-0.06" spread="0.895"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodily pain: Week 28, n=80,74</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" spread="0.941"/>
                    <measurement group_id="O2" value="-1.26" spread="0.976"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodily pain: Week 52, n=67,65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.00" spread="1.084"/>
                    <measurement group_id="O2" value="0.61" spread="1.109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General health: Week 8, n=88,86</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" spread="0.662"/>
                    <measurement group_id="O2" value="0.75" spread="0.674"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General health: Week 12, n=88,88</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87" spread="0.651"/>
                    <measurement group_id="O2" value="0.59" spread="0.658"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General health: Week 28, n=80,74</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="0.693"/>
                    <measurement group_id="O2" value="0.37" spread="0.720"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General health: Week 52, n=67,65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40" spread="0.823"/>
                    <measurement group_id="O2" value="0.58" spread="0.841"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental health: Week 8, n=88,86</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.90" spread="0.825"/>
                    <measurement group_id="O2" value="0.25" spread="0.841"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental health: Week 12, n=88,88</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.707"/>
                    <measurement group_id="O2" value="1.42" spread="0.712"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental health: Week 28, n=80,74</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.69" spread="0.866"/>
                    <measurement group_id="O2" value="-0.21" spread="0.902"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental health: Week 52, n=67,65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.53" spread="0.994"/>
                    <measurement group_id="O2" value="-0.27" spread="1.013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-emotional: Week 8, n=88,86</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.83" spread="0.880"/>
                    <measurement group_id="O2" value="0.50" spread="0.896"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-emotional: Week 12, n=88,88</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" spread="0.934"/>
                    <measurement group_id="O2" value="-0.07" spread="0.946"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-emotional: Week 28, n=80,74</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.91" spread="0.929"/>
                    <measurement group_id="O2" value="0.39" spread="0.964"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-emotional: Week 52, n=67,65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.60" spread="1.193"/>
                    <measurement group_id="O2" value="-0.11" spread="1.216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-physical: Week 8, n=88,86</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.34" spread="0.806"/>
                    <measurement group_id="O2" value="2.64" spread="0.818"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-physical: Week 12, n=88,88</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.39" spread="0.712"/>
                    <measurement group_id="O2" value="1.69" spread="0.716"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-physical: Week 28, n=80,74</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.62" spread="0.799"/>
                    <measurement group_id="O2" value="1.49" spread="0.829"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role-physical: Week 52, n=67,65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.49" spread="0.895"/>
                    <measurement group_id="O2" value="2.22" spread="0.913"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social functioning: Week 8, n=88,86</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.52" spread="0.929"/>
                    <measurement group_id="O2" value="1.55" spread="0.947"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social functioning: Week 12, n=88,88</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="0.774"/>
                    <measurement group_id="O2" value="2.15" spread="0.783"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social functioning: Week 28, n=80,74</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" spread="0.943"/>
                    <measurement group_id="O2" value="0.95" spread="0.980"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social functioning: Week 52, n=67,65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" spread="1.085"/>
                    <measurement group_id="O2" value="-0.33" spread="1.105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4523</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.21</ci_lower_limit>
            <ci_upper_limit>2.49</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5222</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.57</ci_lower_limit>
            <ci_upper_limit>2.43</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0440</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>2.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.35</ci_lower_limit>
            <ci_upper_limit>5.02</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9523</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-2.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.68</ci_lower_limit>
            <ci_upper_limit>0.46</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4811</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.82</ci_lower_limit>
            <ci_upper_limit>1.91</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3834</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.56</ci_lower_limit>
            <ci_upper_limit>2.11</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3983</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.72</ci_lower_limit>
            <ci_upper_limit>2.24</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5617</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-0.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.51</ci_lower_limit>
            <ci_upper_limit>2.15</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8336</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.48</ci_lower_limit>
            <ci_upper_limit>1.18</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9188</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.40</ci_lower_limit>
            <ci_upper_limit>0.57</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6495</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-0.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.96</ci_lower_limit>
            <ci_upper_limit>1.99</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5737</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-0.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.09</ci_lower_limit>
            <ci_upper_limit>2.56</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3963</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.15</ci_lower_limit>
            <ci_upper_limit>2.82</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3220</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.01</ci_lower_limit>
            <ci_upper_limit>3.25</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3485</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.13</ci_lower_limit>
            <ci_upper_limit>3.18</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8064</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.87</ci_lower_limit>
            <ci_upper_limit>1.90</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8687</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.57</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2435</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.29</ci_lower_limit>
            <ci_upper_limit>2.70</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7747</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.15</ci_lower_limit>
            <ci_upper_limit>1.41</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7141</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.26</ci_lower_limit>
            <ci_upper_limit>1.81</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7803</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.65</ci_lower_limit>
            <ci_upper_limit>1.59</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8556</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.35</ci_lower_limit>
            <ci_upper_limit>1.00</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4763</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.61</ci_lower_limit>
            <ci_upper_limit>2.77</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3208</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.35</ci_lower_limit>
            <ci_upper_limit>3.80</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52</title>
        <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
        <time_frame>Baseline (Day 1), Weeks 28 and 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52</title>
          <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 28, n=80,74</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.866"/>
                    <measurement group_id="O2" value="0.95" spread="0.902"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52, n=67,65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="0.907"/>
                    <measurement group_id="O2" value="1.61" spread="0.925"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7910</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.50</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL vitality domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8648</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.03</ci_lower_limit>
            <ci_upper_limit>1.14</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL vitality domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52</title>
        <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
        <time_frame>Baseline (Day 1), Weeks 28 and 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52</title>
          <description>The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 28, n=80,74</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" spread="0.863"/>
                    <measurement group_id="O2" value="0.83" spread="0.898"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52, n=67,65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="0.947"/>
                    <measurement group_id="O2" value="1.58" spread="0.973"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5879</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.75</ci_lower_limit>
            <ci_upper_limit>2.19</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL physical functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8525</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.12</ci_lower_limit>
            <ci_upper_limit>1.26</ci_upper_limit>
            <estimate_desc>SF-36 HRQoL physical functioning domain scor was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52</title>
        <description>EQ-5D-5L consists of 2 concepts-EQ-5D-5L descriptive system and EQ Visual Analogue Scale (EQ-VAS). EQ-5D-5L is self-assessment questionnaire, consisting of 5items covering 5 dimensions (mobility,self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale(no problems, slight problems, moderate problems, severe problems and extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state(e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health), higher the score better the health status. Change from Baseline was calculated as post-dose visit value-Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date.</description>
        <time_frame>Baseline (Day 1) and Week 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52</title>
          <description>EQ-5D-5L consists of 2 concepts-EQ-5D-5L descriptive system and EQ Visual Analogue Scale (EQ-VAS). EQ-5D-5L is self-assessment questionnaire, consisting of 5items covering 5 dimensions (mobility,self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale(no problems, slight problems, moderate problems, severe problems and extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state(e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health), higher the score better the health status. Change from Baseline was calculated as post-dose visit value-Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.041"/>
                    <measurement group_id="O2" value="-0.03" spread="0.040"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3154</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>0.14</ci_upper_limit>
            <estimate_desc>MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EQ Visual Analogue Scale (EQ-VAS) at Week 52</title>
        <description>The EQ-5D-5L consists of 2 concepts -EQ-5D-5L descriptive system and EQ-VAS. The EQ-5D-5L is a self-assessment questionnaire, consisting of five items covering five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by a five-point Likert scale (no problems, slight problems, moderate problems, severe problems, and extreme problems). The range for the EQ-5D-5L index score is 0 to 1 with '0' is worst health and '1' is full health. The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst health one can imagine and 100 represents the best health one can imagine. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
        <time_frame>Baseline (Day 1) and Week 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EQ Visual Analogue Scale (EQ-VAS) at Week 52</title>
          <description>The EQ-5D-5L consists of 2 concepts -EQ-5D-5L descriptive system and EQ-VAS. The EQ-5D-5L is a self-assessment questionnaire, consisting of five items covering five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by a five-point Likert scale (no problems, slight problems, moderate problems, severe problems, and extreme problems). The range for the EQ-5D-5L index score is 0 to 1 with '0' is worst health and '1' is full health. The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst health one can imagine and 100 represents the best health one can imagine. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="3.27"/>
                    <measurement group_id="O2" value="6.8" spread="3.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7651</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-3.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.7</ci_lower_limit>
            <ci_upper_limit>5.9</ci_upper_limit>
            <estimate_desc>MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52</title>
        <description>CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy/Weak scale consisting of 10 items; 2.Chest Pain/Shortness of Breath scale consisting of 4 items; and 3.Cognitive scale consisting of 3 items. The 4 CKD-AQ single items are: (shortness of breath, no activity), (severity-short breath, resting), (difficulty standing for long time) and (difficulty sleeping). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
        <time_frame>Baseline (Day 1) and Week 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52</title>
          <description>CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy/Weak scale consisting of 10 items; 2.Chest Pain/Shortness of Breath scale consisting of 4 items; and 3.Cognitive scale consisting of 3 items. The 4 CKD-AQ single items are: (shortness of breath, no activity), (severity-short breath, resting), (difficulty standing for long time) and (difficulty sleeping). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tired/Low energy/Weak domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.36" spread="2.007"/>
                    <measurement group_id="O2" value="4.07" spread="1.990"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chest pain/Shortness of breath domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.83" spread="1.593"/>
                    <measurement group_id="O2" value="2.28" spread="1.557"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cognitive domain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.17" spread="1.893"/>
                    <measurement group_id="O2" value="2.43" spread="1.852"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shortness of breath, no activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.90" spread="1.861"/>
                    <measurement group_id="O2" value="1.14" spread="1.826"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severity-short breath, Resting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.16" spread="1.869"/>
                    <measurement group_id="O2" value="0.12" spread="1.836"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difficulty standing for long time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.00" spread="2.812"/>
                    <measurement group_id="O2" value="3.30" spread="2.754"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difficulty sleeping</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.27" spread="2.667"/>
                    <measurement group_id="O2" value="1.26" spread="2.611"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9875</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-6.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.05</ci_lower_limit>
            <ci_upper_limit>-0.82</ci_upper_limit>
            <estimate_desc>Tired/Low energy/Weak domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9663</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-4.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.52</ci_lower_limit>
            <ci_upper_limit>0.30</ci_upper_limit>
            <estimate_desc>Chest pain/Shortness of breath domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9930</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-6.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.84</ci_lower_limit>
            <ci_upper_limit>-1.35</ci_upper_limit>
            <estimate_desc>Cognitive domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8765</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-3.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.19</ci_lower_limit>
            <ci_upper_limit>2.12</ci_upper_limit>
            <estimate_desc>Shortness of breath, no activity: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9464</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-4.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.48</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
            <estimate_desc>Severity-short breath, Resting: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9101</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-5.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.09</ci_lower_limit>
            <ci_upper_limit>2.47</ci_upper_limit>
            <estimate_desc>Difficulty standing for long time: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9586</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>-6.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.90</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
            <estimate_desc>Difficulty sleeping: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient Global Impression of Severity (PGI-S)</title>
        <description>The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated worse outcome. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
        <time_frame>Baseline (Day 1), Weeks 8, 12, 28 and 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient Global Impression of Severity (PGI-S)</title>
          <description>The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated worse outcome. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.</description>
          <population>ITT Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8, n=100,100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="0.091"/>
                    <measurement group_id="O2" value="-0.11" spread="0.092"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, n=100,103</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.077"/>
                    <measurement group_id="O2" value="-0.03" spread="0.077"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28, n=92,85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" spread="0.086"/>
                    <measurement group_id="O2" value="-0.07" spread="0.089"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52, n=75,77</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="0.106"/>
                    <measurement group_id="O2" value="0.04" spread="0.105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9810</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.02</ci_lower_limit>
            <ci_upper_limit>0.53</ci_upper_limit>
            <estimate_desc>MMRM model was fitted from Baseline up to Week 8 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6743</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.17</ci_lower_limit>
            <ci_upper_limit>0.26</ci_upper_limit>
            <estimate_desc>MMRM model was fitted from Baseline up to Week 12 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8997</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>0.40</ci_upper_limit>
            <estimate_desc>MMRM model was fitted from Baseline up to Week 28 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8835</p_value>
            <method>MMRM</method>
            <param_type>LS mean difference</param_type>
            <param_value>0.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.12</ci_lower_limit>
            <ci_upper_limit>0.47</ci_upper_limit>
            <estimate_desc>MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)</title>
        <description>Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic (PK) analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. Pharmacokinetic Population comprised of participants for whom a pharmacokinetic sample was obtained and analyzed.</description>
        <time_frame>Pre-dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat 1 mg</title>
            <description>Participants received film-coated tablets of daprodustat 1 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Daprodustat 2 mg</title>
            <description>Participants received film-coated tablets of daprodustat 2 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Daprodustat 4 mg</title>
            <description>Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Daprodustat 6 mg</title>
            <description>Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Daprodustat 8 mg</title>
            <description>Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Daprodustat 10 mg</title>
            <description>Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Daprodustat 12 mg</title>
            <description>Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Daprodustat 16 mg</title>
            <description>Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O9">
            <title>Daprodustat 24 mg</title>
            <description>Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)</title>
          <description>Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic (PK) analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. Pharmacokinetic Population comprised of participants for whom a pharmacokinetic sample was obtained and analyzed.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms.</population>
          <units>Nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Daprodustat: Pre-Dose, n=19,26,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.118" spread="5.0030"/>
                    <measurement group_id="O2" value="1.015" spread="3.1451"/>
                    <measurement group_id="O3" value="0.5787" spread="1.5718"/>
                    <measurement group_id="O4" value="2.867" spread="6.6142"/>
                    <measurement group_id="O5" value="0.1030" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="0.1090" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Daprodustat: 0.5 hour, n=19,26,20,18,0,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.675" spread="8.4998"/>
                    <measurement group_id="O2" value="4.664" spread="8.7508"/>
                    <measurement group_id="O3" value="10.27" spread="20.425"/>
                    <measurement group_id="O4" value="12.58" spread="23.742"/>
                    <measurement group_id="O6" value="145.0" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Daprodustat: 1 hour, n=19,26,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.34" spread="13.435"/>
                    <measurement group_id="O2" value="21.45" spread="42.160"/>
                    <measurement group_id="O3" value="36.78" spread="62.497"/>
                    <measurement group_id="O4" value="45.48" spread="48.765"/>
                    <measurement group_id="O5" value="0.9120" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="79.60" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Daprodustat: 2 hours, n=19,26,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.74" spread="9.9019"/>
                    <measurement group_id="O2" value="20.36" spread="22.210"/>
                    <measurement group_id="O3" value="54.68" spread="80.284"/>
                    <measurement group_id="O4" value="55.62" spread="51.471"/>
                    <measurement group_id="O5" value="32.00" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="27.60" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Daprodustat: 3 hours, n=19,26,19,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.719" spread="5.9144"/>
                    <measurement group_id="O2" value="15.58" spread="13.694"/>
                    <measurement group_id="O3" value="43.34" spread="66.295"/>
                    <measurement group_id="O4" value="56.49" spread="74.357"/>
                    <measurement group_id="O5" value="25.30" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="11.00" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220: Pre-Dose, n=19,26,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7106" spread="0.64028"/>
                    <measurement group_id="O2" value="2.124" spread="2.8721"/>
                    <measurement group_id="O3" value="2.087" spread="2.1371"/>
                    <measurement group_id="O4" value="3.560" spread="4.2255"/>
                    <measurement group_id="O5" value="4.450" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="6.560" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220: 0.5 hour, n=19,25,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7602" spread="0.67950"/>
                    <measurement group_id="O2" value="1.807" spread="2.2007"/>
                    <measurement group_id="O3" value="1.822" spread="2.1355"/>
                    <measurement group_id="O4" value="2.410" spread="2.8243"/>
                    <measurement group_id="O5" value="3.950" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="6.740" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220: 1 hour, n=18,26,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.123" spread="0.76920"/>
                    <measurement group_id="O2" value="1.752" spread="1.8589"/>
                    <measurement group_id="O3" value="1.965" spread="2.2830"/>
                    <measurement group_id="O4" value="3.140" spread="2.4856"/>
                    <measurement group_id="O5" value="3.900" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="10.00" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220: 2 hours, n=19,26,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.745" spread="1.3160"/>
                    <measurement group_id="O2" value="2.969" spread="2.4659"/>
                    <measurement group_id="O3" value="4.008" spread="4.4522"/>
                    <measurement group_id="O4" value="6.336" spread="4.3723"/>
                    <measurement group_id="O5" value="4.700" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="16.20" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220: 3 hours, n=19,26,19,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.911" spread="1.2274"/>
                    <measurement group_id="O2" value="3.535" spread="2.7203"/>
                    <measurement group_id="O3" value="5.553" spread="6.5157"/>
                    <measurement group_id="O4" value="9.372" spread="6.6452"/>
                    <measurement group_id="O5" value="6.090" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="16.60" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506104: Pre-Dose, n=19,26,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.270" spread="0.96071"/>
                    <measurement group_id="O2" value="3.508" spread="4.2066"/>
                    <measurement group_id="O3" value="3.879" spread="3.4207"/>
                    <measurement group_id="O4" value="5.921" spread="5.8981"/>
                    <measurement group_id="O5" value="8.710" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="9.500" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506104: 0.5 hour, n=19,26,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.197" spread="0.85104"/>
                    <measurement group_id="O2" value="2.788" spread="2.9893"/>
                    <measurement group_id="O3" value="3.315" spread="3.4249"/>
                    <measurement group_id="O4" value="4.015" spread="3.7385"/>
                    <measurement group_id="O5" value="7.740" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="8.110" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506104: 1 hour, n=19,26,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.364" spread="0.96292"/>
                    <measurement group_id="O2" value="2.610" spread="2.4761"/>
                    <measurement group_id="O3" value="3.268" spread="3.4808"/>
                    <measurement group_id="O4" value="4.333" spread="3.0505"/>
                    <measurement group_id="O5" value="7.460" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="12.40" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506104: 2 hours, n=19,26,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.966" spread="1.3440"/>
                    <measurement group_id="O2" value="3.583" spread="2.8427"/>
                    <measurement group_id="O3" value="4.989" spread="5.2109"/>
                    <measurement group_id="O4" value="7.130" spread="4.5105"/>
                    <measurement group_id="O5" value="8.930" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="19.60" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506104: 3 hours, n=19,26,19,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.190" spread="1.3898"/>
                    <measurement group_id="O2" value="4.145" spread="3.1757"/>
                    <measurement group_id="O3" value="6.503" spread="7.5130"/>
                    <measurement group_id="O4" value="9.942" spread="7.0616"/>
                    <measurement group_id="O5" value="10.10" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="22.00" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401: Pre-Dose, n=19,26,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.642" spread="1.4836"/>
                    <measurement group_id="O2" value="2.729" spread="1.8934"/>
                    <measurement group_id="O3" value="3.750" spread="3.8006"/>
                    <measurement group_id="O4" value="5.111" spread="4.0632"/>
                    <measurement group_id="O5" value="5.660" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="7.760" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401: 0.5 hour, n=19,26,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.427" spread="1.2870"/>
                    <measurement group_id="O2" value="2.170" spread="1.6621"/>
                    <measurement group_id="O3" value="3.263" spread="3.8737"/>
                    <measurement group_id="O4" value="3.800" spread="2.8722"/>
                    <measurement group_id="O5" value="4.960" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="6.460" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401: 1 hour, n=19,26,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.399" spread="1.4595"/>
                    <measurement group_id="O2" value="1.979" spread="1.6316"/>
                    <measurement group_id="O3" value="3.146" spread="4.0334"/>
                    <measurement group_id="O4" value="3.776" spread="3.4411"/>
                    <measurement group_id="O5" value="4.810" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="6.630" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401: 2 hours, n=19,26,20,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.690" spread="1.6309"/>
                    <measurement group_id="O2" value="2.338" spread="2.1467"/>
                    <measurement group_id="O3" value="3.711" spread="5.0223"/>
                    <measurement group_id="O4" value="4.892" spread="4.7877"/>
                    <measurement group_id="O5" value="5.190" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="8.290" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401: 3 hours, n=19,26,19,18,1,1,0,0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.847" spread="1.7376"/>
                    <measurement group_id="O2" value="2.734" spread="2.6846"/>
                    <measurement group_id="O3" value="4.715" spread="7.2788"/>
                    <measurement group_id="O4" value="6.631" spread="7.1049"/>
                    <measurement group_id="O5" value="5.760" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="10.20" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)</title>
        <description>Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12.</description>
        <time_frame>Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed. Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat 1 mg</title>
            <description>Participants received film-coated tablets of daprodustat 1 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Daprodustat 2 mg</title>
            <description>Participants received film-coated tablets of daprodustat 2 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Daprodustat 4 mg</title>
            <description>Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Daprodustat 6 mg</title>
            <description>Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Daprodustat 8 mg</title>
            <description>Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Daprodustat 10 mg</title>
            <description>Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Daprodustat 12 mg</title>
            <description>Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Daprodustat 16 mg</title>
            <description>Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O9">
            <title>Daprodustat 24 mg</title>
            <description>Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)</title>
          <description>Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed. Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms.</population>
          <units>Nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Daprodustat</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.118" spread="5.0030"/>
                    <measurement group_id="O2" value="1.015" spread="3.1451"/>
                    <measurement group_id="O3" value="0.5787" spread="1.5718"/>
                    <measurement group_id="O4" value="2.867" spread="6.6142"/>
                    <measurement group_id="O5" value="0.1030" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="0.1090" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7106" spread="0.64028"/>
                    <measurement group_id="O2" value="2.124" spread="2.8721"/>
                    <measurement group_id="O3" value="2.087" spread="2.1371"/>
                    <measurement group_id="O4" value="3.560" spread="4.2255"/>
                    <measurement group_id="O5" value="4.450" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="6.560" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.270" spread="0.96071"/>
                    <measurement group_id="O2" value="3.508" spread="4.2066"/>
                    <measurement group_id="O3" value="3.879" spread="3.4207"/>
                    <measurement group_id="O4" value="5.921" spread="5.8981"/>
                    <measurement group_id="O5" value="8.710" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="9.500" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.642" spread="1.4836"/>
                    <measurement group_id="O2" value="2.729" spread="1.8934"/>
                    <measurement group_id="O3" value="3.750" spread="3.8006"/>
                    <measurement group_id="O4" value="5.111" spread="4.0632"/>
                    <measurement group_id="O5" value="5.660" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="7.760" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)</title>
        <description>Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12.</description>
        <time_frame>Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed. Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat 1 mg</title>
            <description>Participants received film-coated tablets of daprodustat 1 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Daprodustat 2 mg</title>
            <description>Participants received film-coated tablets of daprodustat 2 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Daprodustat 4 mg</title>
            <description>Participants received film-coated tablets of daprodustat 4 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Daprodustat 6 mg</title>
            <description>Participants received film-coated tablets of daprodustat 6 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Daprodustat 8 mg</title>
            <description>Participants received film-coated tablets of daprodustat 8 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Daprodustat 10 mg</title>
            <description>Participants received film-coated tablets of daprodustat 10 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Daprodustat 12 mg</title>
            <description>Participants received film-coated tablets of daprodustat 12 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Daprodustat 16 mg</title>
            <description>Participants received film-coated tablets of daprodustat 16 mg orally once daily for 52 weeks.</description>
          </group>
          <group group_id="O9">
            <title>Daprodustat 24 mg</title>
            <description>Participants received film-coated tablets of daprodustat 24 mg orally once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)</title>
          <description>Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the indicated time points were analyzed. Blood samples were not collected for PK analysis of daprodustat 12, 16 and 24 mg arms.</population>
          <units>Nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Daprodustat</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.74" spread="10.998"/>
                    <measurement group_id="O2" value="32.29" spread="40.166"/>
                    <measurement group_id="O3" value="76.92" spread="81.867"/>
                    <measurement group_id="O4" value="100.2" spread="74.086"/>
                    <measurement group_id="O5" value="32.00" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="145.0" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.160" spread="1.2596"/>
                    <measurement group_id="O2" value="4.139" spread="3.3561"/>
                    <measurement group_id="O3" value="5.780" spread="6.2840"/>
                    <measurement group_id="O4" value="10.36" spread="6.3377"/>
                    <measurement group_id="O5" value="6.090" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="16.60" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.477" spread="1.3625"/>
                    <measurement group_id="O2" value="5.212" spread="4.5562"/>
                    <measurement group_id="O3" value="7.075" spread="7.1313"/>
                    <measurement group_id="O4" value="11.60" spread="6.8731"/>
                    <measurement group_id="O5" value="10.10" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="22.00" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.283" spread="1.8210"/>
                    <measurement group_id="O2" value="3.565" spread="2.6091"/>
                    <measurement group_id="O3" value="5.328" spread="6.9034"/>
                    <measurement group_id="O4" value="7.836" spread="6.6199"/>
                    <measurement group_id="O5" value="5.760" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                    <measurement group_id="O6" value="10.20" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-cause mortality, treatment emergent non-serious adverse events and serious adverse events were collected up to follow-up visit (Week 58)</time_frame>
      <desc>Safety Population comprised of all randomized participants who received at least one dose of randomized treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Daprodustat</title>
          <description>Participants received daprodustat film-coated tablets with titrated dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16, and 24 milligrams (mg) orally once daily for up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter [g/dL]).</description>
        </group>
        <group group_id="E2">
          <title>Darbepoetin Alfa</title>
          <description>Participants received darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection with 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 120, 160, 200, 300 and 400 microgram (mcg) for 52 weeks. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Aortic valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypertensive heart disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertrophic cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinopathy hypertensive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Volvulus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Bloody peritoneal effluent</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Diabetic gastropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hydrocholecystis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="157"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="157"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Post procedural infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Clostridial sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Device related bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Escherichia infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Helicobacter gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Infected skin ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Leptospirosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Streptococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula site complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Anaemia postoperative</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Arteriovenous graft thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Inadequate haemodialysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Open globe injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Peritoneal dialysate leakage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Peritoneal dialysis complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Procedural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Unintentional medical device removal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Vascular access malfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="157"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="157"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Prostate cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Renal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Thyroid cancer stage I</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypertensive encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Uraemic encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Azotaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="7" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypertensive urgency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Lymphocele</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="157"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Steal syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="157"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="76" subjects_at_risk="157"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="17" subjects_affected="14" subjects_at_risk="157"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="16" subjects_affected="11" subjects_at_risk="157"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="13" subjects_affected="8" subjects_at_risk="157"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="7" subjects_at_risk="157"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="157"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="157"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula site complication</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="157"/>
                <counts group_id="E2" events="13" subjects_affected="8" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="157"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="12" subjects_affected="7" subjects_at_risk="157"/>
                <counts group_id="E2" events="12" subjects_affected="9" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="157"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="51" subjects_affected="27" subjects_at_risk="157"/>
                <counts group_id="E2" events="35" subjects_affected="24" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Dialysis hypotension</sub_title>
                <counts group_id="E1" events="34" subjects_affected="21" subjects_at_risk="157"/>
                <counts group_id="E2" events="22" subjects_affected="15" subjects_at_risk="155"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="157"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="155"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03029208
org study id: 201410
secondary id: 2016-000507-86
nct id: NCT03029208
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat
      in subjects with anemia associated with CKD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52)
time frame: Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)
description: Blood samples were collected from participants for Hgb measurement. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputations. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. An analysis of covariance (ANCOVA) model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95 percent (%) confidence interval (CI) for the treatment difference (daprodustat-darbepoetin alfa).
measure: Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52
time frame: Baseline (Day 1) to Week 52
description: Total IV iron dose per participant was calculated from Day 1 to the earliest of (Week 52 visit date, first blood [red blood cells or whole blood] transfusion date and treatment stop date plus [+] 1 day) which corresponds to the time while the participant was on randomized treatment and before receiving a blood transfusion. Average monthly IV iron dose was calculated by Total IV iron dose divided by (/) (the number of days from Day 1 to the earliest of [Week 52 visit date, first blood transfusion date and treatment stop date +1] /30.4375 days). Data for participants until they underwent a red blood cells or whole blood transfusion was included in the analysis.
measure: Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52
time frame: Baseline (Day 1) and Week 52
description: SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using mixed model repeated measures (MMRM) model.
measure: Change From Baseline in SBP, DBP, MAP at End of Treatment
time frame: Baseline (Day 1) and end of treatment (last on-treatment value until Week 52)
description: SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. End of treatment value for the blood pressure parameters were defined as the latest value on or before the last non-zero dose date plus (+) 1 day. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using ANCOVA model.
measure: Blood Pressure (BP) Exacerbation Events Rate Per 100 Participant Years
time frame: Up to Week 52
description: BP exacerbation event is defined (based on post-dialysis BP) as SBP >=25 millimeter of mercury (mmHg) increased from Baseline or SBP >=180 mmHg; or DBP >=15 mmHg increased from Baseline or DBP >=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the Negative Binomial Model.
measure: Number of Participants With at Least One Blood Pressure Exacerbation Event During Study
time frame: Up to Week 52
description: BP exacerbation was defined (based on post-dialysis BP) as: SBP >=25 mmHg increased from Baseline or SBP >=180 mmHg; DBP >=15 mmHg increased from Baseline or DBP >=110 mmHg. Number of participants with at least one blood pressure exacerbation event is presented.
measure: Change From Baseline in Post-randomization Hgb at Week 52
time frame: Baseline (Day 1) and Week 52
description: Blood samples were collected from participants for Hgb measurements. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
measure: Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52)
time frame: Weeks 28 to 52
description: Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as number of participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL.
measure: Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis
time frame: Weeks 28 to 52
description: Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'.
measure: Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Superiority Analysis
time frame: Weeks 28 to 52
description: Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'.
measure: Number of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria
time frame: Up to Week 52
description: Number of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented.
measure: Change From Baseline in Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52
time frame: Baseline (Day 1), Weeks 8, 12, 28 and 52
description: The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
measure: Change From Baseline in Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52
time frame: Baseline (Day 1), Weeks 8, 12, 28 and 52
description: The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
measure: Change From Baseline in SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
time frame: Baseline (Day 1), Weeks 8, 12, 28 and 52
description: The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain, general health, mental health, role-emotional (role limitations caused by emotional problems), role-physical (role limitations caused by physical problems), social functioning, physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
measure: Change From Baseline in Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52
time frame: Baseline (Day 1), Weeks 28 and 52
description: The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
measure: Change From Baseline in Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 28, 52
time frame: Baseline (Day 1), Weeks 28 and 52
description: The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as post-dose visit value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
measure: Change From Baseline in Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52
time frame: Baseline (Day 1) and Week 52
description: EQ-5D-5L consists of 2 concepts-EQ-5D-5L descriptive system and EQ Visual Analogue Scale (EQ-VAS). EQ-5D-5L is self-assessment questionnaire, consisting of 5items covering 5 dimensions (mobility,self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale(no problems, slight problems, moderate problems, severe problems and extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state(e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health), higher the score better the health status. Change from Baseline was calculated as post-dose visit value-Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date.
measure: Change From Baseline in EQ Visual Analogue Scale (EQ-VAS) at Week 52
time frame: Baseline (Day 1) and Week 52
description: The EQ-5D-5L consists of 2 concepts -EQ-5D-5L descriptive system and EQ-VAS. The EQ-5D-5L is a self-assessment questionnaire, consisting of five items covering five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by a five-point Likert scale (no problems, slight problems, moderate problems, severe problems, and extreme problems). The range for the EQ-5D-5L index score is 0 to 1 with '0' is worst health and '1' is full health. The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst health one can imagine and 100 represents the best health one can imagine. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
measure: Change From Baseline in Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Week 52
time frame: Baseline (Day 1) and Week 52
description: CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy/Weak scale consisting of 10 items; 2.Chest Pain/Shortness of Breath scale consisting of 4 items; and 3.Cognitive scale consisting of 3 items. The 4 CKD-AQ single items are: (shortness of breath, no activity), (severity-short breath, resting), (difficulty standing for long time) and (difficulty sleeping). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
measure: Change From Baseline in Patient Global Impression of Severity (PGI-S)
time frame: Baseline (Day 1), Weeks 8, 12, 28 and 52
description: The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated worse outcome. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
measure: Plasma Concentration of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
time frame: Pre-dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12
description: Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic (PK) analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12. Pharmacokinetic Population comprised of participants for whom a pharmacokinetic sample was obtained and analyzed.
measure: Observed Concentration at Dosing Interval (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
time frame: Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12
description: Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12.
measure: Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13)
time frame: Pre-Dose, 0.5, 1, 2 and 3 hours post-dose; each pharmacokinetic sample was taken at Week 4 or 8 or 12
description: Pharmacokinetic samples were collected at pre-dose, 0.5, 1, 2 and 3 hours post-dose on Week 4 or 8 or 12 for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites GSK2391220 (M2), GSK2506104 (M3), and GSK2531401 (M13). GSK2391220, GSK2506104 and GSK2531401 are the metabolites of Daprodustat (GSK1278863). Protocol allowed participants to provide pharmacokinetic samples on Week 4 or 8 or 12.
arm group label: Daprodustat treated anemic subjects
arm group type: Experimental
description: Subjects will receive oral daprodustat once daily.
arm group label: Darbepoetin alfa treated anemic subjects
arm group type: Active Comparator
description: Subjects will receive darbepoetin alfa subcutaneously or intravenously.
intervention type: Drug
intervention name: Daprodustat
description: Daprodustat will be supplied as film coated tablets for oral administration containing 1, 2, 4, 6, 8, or 10 mg of daprodustat. Doses of 12, 16, and 24 mg of daprodustat will be provided using multiples of these tablet strengths.
arm group label: Daprodustat treated anemic subjects
intervention type: Drug
intervention name: Darbepoetin alfa
description: Darbepoetin alfa will be supplied as prefilled syringes (PFS) for SC/IV injection available in strengths: 20, 30, 40, 60, 80, 100 and 150 mcg.
arm group label: Darbepoetin alfa treated anemic subjects
intervention type: Drug
intervention name: Iron therapy
description: Iron therapy will be administered if ferritin is <=100 ng/mL and/or TSAT is <=20%.
arm group label: Daprodustat treated anemic subjects
arm group label: Darbepoetin alfa treated anemic subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Argentina
country: Australia
country: Canada
country: Germany
country: India
country: Italy
country: Korea, Republic of
country: Malaysia
country: Mexico
country: Poland
country: Russian Federation
country: South Africa
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Anemia
mesh term: Darbepoetin alfa
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: http://clinicalstudydatarequest.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 