<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/NCT02969655</url>
  </required_header>
  <id_info>
    <org_study_id>201754</org_study_id>
    <nct_id>NCT02969655</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)</brief_title>
  <official_title>A 52-week, Phase III, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Currently ESA Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Daprodustat is a drug that is currently being developed as a treatment for renal anemia .&#xD;
      This study is to evaluate the efficacy and safety of daprodustat following a switch from&#xD;
      erythropoiesis-stimulating agent (ESA) in Japanese HD subjects with renal anemia who are&#xD;
      currently treated with ESA. The primary objective is to demonstrate non-inferiority of&#xD;
      daprodustat to darbepoetin alfa. This study is a 52-week, Phase III, double-blind,&#xD;
      active-controlled, parallel-group, multi-center study. The total duration of the study will&#xD;
      be approximately 58 weeks including screening and follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2016</start_date>
  <completion_date type="Actual">July 2, 2018</completion_date>
  <primary_completion_date type="Actual">July 2, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)</measure>
    <time_frame>Weeks 40 to 52</time_frame>
    <description>The mean hemoglobin during the Evaluation Period was estimated by a statistical model.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)</measure>
    <time_frame>Weeks 40 to 52</time_frame>
    <description>The percentage of participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized. Odds ratio was estimated using a logistic regression and provided along with its 95% CI and a one-sided p-value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hgb (Hgb Increase Rate) at Week 4</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>Change from Baseline was calculated as the post-dose Week 4 visit value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Hgb Change From Baseline Category at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>Percentage of participants within each category were provided only for daprodustat and the categories were classified into 6 (i.e., &lt;=-2, &gt;-2 to -1, &gt;-1 to 0, &gt;0 to 1, &gt;1 to 2, &gt;2 grams per deciliter [g/dL]). In addition, 'within 1.0 g/dL (i.e., &lt;=-1 and &gt;=1) and over 2.0 g/dL (i.e., &lt;-2 and &gt;2) categories were provided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Daprodustat Dose Level by Visit</measure>
    <time_frame>Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44, and 48)</time_frame>
    <description>Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Daprodustat. Median along with the interquartile range (25th and 75th percentile) has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of Darbepoetin Alfa Dose Level by Visit</measure>
    <time_frame>Day 1, Weeks 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32,34,36,38,40,42,44,46,48, and 50</time_frame>
    <description>Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Darbepoetin Alfa. Median along with the interquartile range (25th and 75th percentile) has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Treatment Interruption Due to Hgb &gt;13 g/dL</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Duration of treatment interruption due to Hgb &gt;13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for the daprodustat group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Dose Adjustments for Daprodustat</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Number of dose adjustments has been presented only for daprodustat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hgb Values at Each Assessment Visit</measure>
    <time_frame>Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52</time_frame>
    <description>Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hgb Values at Each Assessment Visit</measure>
    <time_frame>Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52</time_frame>
    <description>Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calcuated as the post-dose visit value minus the Baseline value. Change from Baseline Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) at Each Assessment Visit</measure>
    <time_frame>Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52</time_frame>
    <description>Percentage of participants with Hgb within the target range was summarized at each assessment visit by treatment group have been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time in Hgb Target Range (10.0 to 12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)</measure>
    <time_frame>Weeks 40 to 52</time_frame>
    <description>Percentage of time in Hgb target range (10.0 to 12.0 g/dL) during the primary efficacy evaluation period (Weeks 40 to 52) for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Had an Hgb Level of Less Than 7.5 g/dL</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>If an initial Hgb value was less than 7.5 g/dL, measurement was repeated at the same study visit (using the same sample) to calculate the average. If the average met the Hgb stopping criteria, study treatment was permanently discontinued. Number of participants who had an Hgb level of less than 7.5 g/dL has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Number of participants who had an Hgb increase of more than 2 g/dL over any 4 weeks for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Had an Hgb Level of More Than 13.0 g/dL</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Number of participants who had an Hgb increase of more than 13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Episodes With Hgb Level of More Than 13.0 g/dL</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Number of episodes with Hgb level of more than 13.0 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under Plasma Concentration Curve From Time Zero to 4 Hours (AUC [0 - 4]) of Plasma Daprodustat</measure>
    <time_frame>0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24</time_frame>
    <description>Blood samples for Pharmacokinetic (PK) analysis of daprodustat were collected as the time points provided. PK parameters were calculated by standard non-compartmental analysis according to current working practices and using the currently supported version of WinNonlin (version 6.3 or higher). NA indicates geometric co-efficient of variation could not be calculated as a single participant was analyzed. Data has been provided as a consolidated values for at all time-points (0,1,2,3,and 4 hours post-dose) as provided for a single value at Weeks 12 and 24 respectively. PK population comprised of all daprodustat-treated participants from whom PK samples were collected and analyzed. Data was not calculated for darbepoetin alfa group as the primary interest of analysis was Daprodustat and not comparator drug (darbepoetin alfa). Data is combined from Week 12 and Week 24 data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Concentration (Cmax) of Plasma Daprodustat</measure>
    <time_frame>0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24</time_frame>
    <description>Blood samples for PK analysis of daprodustat were collected as the time points provided. PK parameters were calculated by standard non-compartmental analysis according to current working practices and using the currently supported version of WinNonlin (version 6.3 or higher). Data has been provided as a consolidated values for at all time-points (0,1,2,3,and 4 hours post-dose) as provided for a single value at Weeks 12 and 24 respectively. Data was not calculated for darbepoetin alfa group as the primary interest of analysis was Daprodustat and not comparator drug (darbepoetin alfa). Data is combined from Week 12 and Week 24 data.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">271</enrollment>
  <condition>Anaemia</condition>
  <arm_group>
    <arm_group_label>Daprodustat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive oral daprodustat once daily and intravenous (IV) darbepoetin alfa placebo once weekly for 52 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Darbepoetin alfa</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive IV darbepoetin alfa once weekly and oral daprodustat placebo once daily for 52 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daprodustat small</intervention_name>
    <description>Available as 7.0 millimeter (mm) round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, or 4 mg of daprodustat as active ingredient</description>
    <arm_group_label>Daprodustat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daprodustat small placebo</intervention_name>
    <description>Available as 7.0 mm round, standard biconvex, white film coated tablets containing no daprodustat</description>
    <arm_group_label>Darbepoetin alfa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daprodustat large</intervention_name>
    <description>Available as 9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of daprodustat as active ingredient</description>
    <arm_group_label>Daprodustat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daprodustat large placebo</intervention_name>
    <description>Available as 9.0 mm round, standard biconvex, white film coated tablets containing no daprodustat</description>
    <arm_group_label>Darbepoetin alfa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Darbepoetin alfa</intervention_name>
    <description>Available as 0.5 mL plastic prefilled syringes (PFS) for IV injection each containing 10, 15, 20, 30, 40 or 60 mcg of darbepoetin alfa in a clear and colorless solution.</description>
    <arm_group_label>Darbepoetin alfa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Darbepoetin alfa placebo</intervention_name>
    <description>Available as 0.5 mL plastic PFS for IV injection containing no darbepoetin alfa in a clear and colorless solution.</description>
    <arm_group_label>Daprodustat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Age (informed consent): &gt;=20 years of age&#xD;
&#xD;
          -  Dialysis: On HD or hemodiafiltration (HDF) given three times weekly for at least 12&#xD;
             weeks prior to screening&#xD;
&#xD;
          -  ESAs: Use of one and the same ESA for 10 weeks prior to screening&#xD;
&#xD;
          -  ESA dose: Darbepoetin alfa 10 to 60 μg per week, epoetin (including biosimilars)&#xD;
             &lt;=9000 international units (IU) per week, or epoetin beta pegol &lt;=250 μg per 4 weeks&#xD;
&#xD;
          -  Hgb:&gt;=9.5 g/dL and &lt;=12.5 g/dL. Determined at the site using an Hgb analyzer&#xD;
&#xD;
          -  Iron parameters: Ferritin &gt;100 nanogram (ng)/millilitre (mL) or transferrin saturation&#xD;
             (TSAT) &gt;20 percent (screening verification only)&#xD;
&#xD;
          -  Gender (screening verification only): Female or male&#xD;
&#xD;
        Females: Not pregnant [demonstrated to be negative for human chorionic gonadotropin (hCG)&#xD;
        in serum], not breast-feeding, and meet at least one of the following:&#xD;
&#xD;
        • Females of non-childbearing potential are defined as follows:&#xD;
&#xD;
        Pre-menopausal with at least one of the following and no plans to utilise assisted&#xD;
        reproductive techniques (e.g., in vitro fertilisation or donor embryo transfer):&#xD;
&#xD;
          -  History of bilateral tubal ligation or salpingectomy&#xD;
&#xD;
          -  History of hysteroscopic tubal occlusion and postoperatively documented bilateral&#xD;
             tubal obstruction&#xD;
&#xD;
          -  History of hysterectomy&#xD;
&#xD;
          -  History of bilateral oophorectomy Postmenopausal defined as A) females 60 years of age&#xD;
             or older or B) In females &lt; 60 years of age, 12 months of spontaneous amenorrhea [in&#xD;
             questionable cases a blood sample with postmenopausal follicle stimulating hormone&#xD;
             (FSH) and estradiol concentrations is confirmatory (see separately specified reference&#xD;
             ranges)]. Females on hormone replacement therapy (HRT) whose menopausal status is in&#xD;
             doubt will be required to use one of the most effective contraception methods if they&#xD;
             wish to continue their HRT during the study. Otherwise they must discontinue HRT to&#xD;
             allow confirmation of post-menopausal status prior to study enrolment.&#xD;
&#xD;
             • Females of childbearing potential must agree to comply with one of the contraception&#xD;
             methods listed as requirements in &quot;GlaxoSmithKline (GSK) Listing of Most Effective&#xD;
             Contraceptive Methods for Females of Childbearing Potential from 28 days prior to the&#xD;
             first dose of study medication until the completion of the follow-up visit.&#xD;
&#xD;
          -  Informed consent: Written informed consent, including adherence to the requirements&#xD;
             and conditions specified in the consent form and the protocol, must be obtained from&#xD;
             each subject.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        CKD-related criteria&#xD;
&#xD;
          -  Kidney transplant: Planned living-related kidney transplant during the study&#xD;
&#xD;
        Anemia-related criteria&#xD;
&#xD;
          -  Aplasia: History of bone-marrow hypoplasia or pure red cell aplasia&#xD;
&#xD;
          -  Other causes of anemia: pernicious anemia, thalassemia, sickle cell anemia, or&#xD;
             myelodysplastic syndromes&#xD;
&#xD;
          -  Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or&#xD;
             esophageal ulcer disease OR clinically significant GI bleeding within 10 weeks prior&#xD;
             to screening or during a period from screening to Day 1&#xD;
&#xD;
        Cardiovascular disease-related criteria&#xD;
&#xD;
          -  Myocardial infarction, acute coronary syndrome, stroke, or transient ischemic attack:&#xD;
             Diagnosed within 10 weeks prior to screening or during a period from screening to Day&#xD;
             1&#xD;
&#xD;
          -  Heart failure: Chronic Class IV heart failure, as defined by the New York Heart&#xD;
             Association (NYHA) functional classification system&#xD;
&#xD;
          -  Corrected QT (QTc) Interval (screening verification only): QTc &gt;500 milliseconds&#xD;
             (msec); or QTc &gt;530 msec in subjects with bundle branch block Note: QT interval&#xD;
             corrected using the Bazett's formula (QTcB) will be used, and electrocardiogram (ECG)&#xD;
             can be mechanically or manually read&#xD;
&#xD;
        Other disease-related criteria:&#xD;
&#xD;
          -  Liver disease (if any of the following occurs):&#xD;
&#xD;
               -  Alanine transaminase (ALT) &gt;2 upper limit of normal (ULN)&#xD;
&#xD;
               -  Bilirubin &gt;1.5×ULN (isolated bilirubin &gt;1.5 ULN is acceptable if bilirubin is&#xD;
                  fractionated and direct bilirubin is &lt;35 percent)&#xD;
&#xD;
               -  Current unstable active liver or biliary disease (generally defined by the onset&#xD;
                  of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric&#xD;
                  varices, persistent jaundice, or cirrhosis)&#xD;
&#xD;
          -  Malignancy: History of malignancy within 2 years prior to screening, currently&#xD;
             receiving treatment for cancer, or complex kidney cyst &gt;3 centimeters (cm) (II F, III&#xD;
             or IV based on the Bosniak classification)&#xD;
&#xD;
        Concomitant medication and other study treatment-related criteria&#xD;
&#xD;
          -  Iron: Planned use of intravenous iron during the screening phase or during a period&#xD;
             from Day 1 to Week 4&#xD;
&#xD;
          -  Severe allergic reactions: History of severe allergic or anaphylactic reactions or&#xD;
             hypersensitivity to excipients in the investigational product.&#xD;
&#xD;
          -  Drugs and supplements: Use or planned use of any prescription or non-prescription&#xD;
             drugs or dietary supplements that are prohibited during the study period [prohibited&#xD;
             medications: strong inducers and inhibitor of Cytochrome P450 (CYP) 2C8].&#xD;
&#xD;
          -  Prior investigational product exposure: Use of an investigational agent within 30 days&#xD;
             or five half lives of the investigational agent (whichever is longer)&#xD;
&#xD;
          -  Prior treatment with daprodustat: Any prior treatment with daprodustat for a treatment&#xD;
             duration of &gt;30 days&#xD;
&#xD;
        General health-related criteria&#xD;
&#xD;
          -  Other conditions: Any other condition, clinical or laboratory abnormality, or&#xD;
             examination finding that the investigator (or subinvestigator) considers would put the&#xD;
             subject at unacceptable risk, which may affect study compliance or prevent&#xD;
             understanding of the aims or investigational procedures or possible consequences of&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</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>Aichi</city>
        <zip>441-8023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>446-0053</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>446-0065</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>454-0932</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>455-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>462-0802</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>486-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>276-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ehime</city>
        <zip>790-0962</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ehime</city>
        <zip>792-0812</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukui</city>
        <zip>918-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>804-0094</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>811-0120</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>811-0213</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>818-0083</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukushima</city>
        <zip>963-8002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukushima</city>
        <zip>963-8071</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gunma</city>
        <zip>370-0615</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gunma</city>
        <zip>372-0817</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gunma</city>
        <zip>375-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>004-0814</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>007-0803</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>073-0022</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>073-0196</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ibaraki</city>
        <zip>300-0062</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ibaraki</city>
        <zip>302-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ibaraki</city>
        <zip>305-0861</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kagawa</city>
        <zip>761-8024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>224-0032</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>227-0046</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>234-0054</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>235-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kyoto</city>
        <zip>613-0034</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miyagi</city>
        <zip>981-0954</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nagano</city>
        <zip>390-0821</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nagano</city>
        <zip>390-1401</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nagano</city>
        <zip>399-8292</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Okayama</city>
        <zip>714-0043</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>543-0052</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>547-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>584-0082</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>594-0076</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saitama</city>
        <zip>348-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>424-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>158-0094</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>169-0075</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toyama</city>
        <zip>930-0065</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toyama</city>
        <zip>938-8502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Yamagata</city>
        <zip>990-0834</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Yamaguchi</city>
        <zip>755-0155</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <reference>
    <citation>Akizawa T, Nangaku M, Yonekawa T, Okuda N, Kawamatsu S, Onoue T, Endo Y, Hara K, Cobitz AR. Efficacy and Safety of Daprodustat Compared with Darbepoetin Alfa in Japanese Hemodialysis Patients with Anemia: A Randomized, Double-Blind, Phase 3 Trial. Clin J Am Soc Nephrol. 2020 Aug 7;15(8):1155-1165. doi: 10.2215/CJN.16011219. Epub 2020 Jul 28.</citation>
    <PMID>32723804</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>June 21, 2019</results_first_submitted>
  <results_first_submitted_qc>November 21, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 29, 2019</results_first_posted>
  <last_update_submitted>November 13, 2020</last_update_submitted>
  <last_update_submitted_qc>November 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Safety</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Daprodustat</keyword>
  <keyword>Chronic kidney disease</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>
    <mesh_term>Glycine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study is 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 is available via the Clinical Study Data Request site (copy the URL below to your browser)</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>https://www.clinicalstudydatarequest.com/Posting.aspx?ID=20737</ipd_url>
  </patient_data>
  <provided_document_section>
    <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>August 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT02969655/SAP_000.pdf</document_url>
    </provided_document>
    <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>July 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT02969655/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 50 centers, contracted in Japan, enrolled and randomized participants. A total of 271 participants were enrolled and randomized in this study.</recruitment_details>
      <pre_assignment_details>A total of 332 participants were screened of which 61 failed screening reasons being participants did not meet inclusion/exclusion criteria (48), physician decision (3) and withdrawn by participant (10), hence 271 participants were enrolled and randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Daprodustat</title>
          <description>Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Darbepoetin Alfa</title>
          <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="136"/>
                <participants group_id="P2" count="135"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="115"/>
                <participants group_id="P2" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol-specified withdrawal criteria</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="8"/>
              </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 oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Darbepoetin Alfa</title>
          <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</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="136"/>
            <count group_id="B2" value="135"/>
            <count group_id="B3" value="271"/>
          </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="64.1" spread="10.30"/>
                    <measurement group_id="B2" value="63.5" spread="10.54"/>
                    <measurement group_id="B3" value="63.8" spread="10.40"/>
                  </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="45"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Count of participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Asian - Japanese heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="136"/>
                    <measurement group_id="B2" value="135"/>
                    <measurement group_id="B3" value="271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)</title>
        <description>The mean hemoglobin during the Evaluation Period was estimated by a statistical model.</description>
        <time_frame>Weeks 40 to 52</time_frame>
        <population>Intent to treat (ITT) Population comprised of all randomized participants who had a Baseline and at least one post Baseline schedule Hgb assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)</title>
          <description>The mean hemoglobin during the Evaluation Period was estimated by a statistical model.</description>
          <population>Intent to treat (ITT) Population comprised of all randomized participants who had a Baseline and at least one post Baseline schedule Hgb assessment.</population>
          <units>Grams per deciliter (g/dL)</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="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.89" spread="0.062"/>
                    <measurement group_id="O2" value="10.83" spread="0.060"/>
                  </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 established if the lower limit of the 95% CI was greater than -1.0 g/dL. Even if the 95% CI for the difference was completely negative (i.e. lied fully within the range -1.0 to &lt;0 g/dL) non-inferiority was concluded on condition that the mean Hgb estimated in the daprodustat group was within the target range.</non_inferiority_desc>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>The p value on this table is one-sided and calculated for the non-inferiority assessment.</p_value_desc>
            <method>Mixed model repeated measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.23</ci_upper_limit>
            <estimate_desc>Analysis was performed by a MMRM with covariates of treatment, Baseline Hgb, visit, treatment-by-visit interaction, Baseline-by-visit interaction.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)</title>
        <description>The percentage of participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized. Odds ratio was estimated using a logistic regression and provided along with its 95% CI and a one-sided p-value.</description>
        <time_frame>Weeks 40 to 52</time_frame>
        <population>Modified Intent to treat (mITT) comprised of all ITT participants who had at least one Hgb measurement during the evaluation period.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)</title>
          <description>The percentage of participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized. Odds ratio was estimated using a logistic regression and provided along with its 95% CI and a one-sided p-value.</description>
          <population>Modified Intent to treat (mITT) comprised of all ITT participants who had at least one Hgb measurement during the evaluation period.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Responder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                    <measurement group_id="O2" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-responder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                  </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>0.7442</p_value>
            <p_value_desc>The p value on this table is one-sided and calculated for the superiority assessment.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.76</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>1.71</ci_upper_limit>
            <estimate_desc>Analysis was performed by logistic regression with covariates of treatment and Baseline Hgb.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hgb (Hgb Increase Rate) at Week 4</title>
        <description>Change from Baseline was calculated as the post-dose Week 4 visit value minus the Baseline value.</description>
        <time_frame>Baseline and Week 4</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hgb (Hgb Increase Rate) at Week 4</title>
          <description>Change from Baseline was calculated as the post-dose Week 4 visit value minus the Baseline value.</description>
          <population>ITT Population</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.42" spread="0.898"/>
                    <measurement group_id="O2" value="0.08" spread="0.525"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by Hgb Change From Baseline Category at Week 4</title>
        <description>Percentage of participants within each category were provided only for daprodustat and the categories were classified into 6 (i.e., &lt;=-2, &gt;-2 to -1, &gt;-1 to 0, &gt;0 to 1, &gt;1 to 2, &gt;2 grams per deciliter [g/dL]). In addition, 'within 1.0 g/dL (i.e., &lt;=-1 and &gt;=1) and over 2.0 g/dL (i.e., &lt;-2 and &gt;2) categories were provided.</description>
        <time_frame>Week 4</time_frame>
        <population>ITT Population. Data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by Hgb Change From Baseline Category at Week 4</title>
          <description>Percentage of participants within each category were provided only for daprodustat and the categories were classified into 6 (i.e., &lt;=-2, &gt;-2 to -1, &gt;-1 to 0, &gt;0 to 1, &gt;1 to 2, &gt;2 grams per deciliter [g/dL]). In addition, 'within 1.0 g/dL (i.e., &lt;=-1 and &gt;=1) and over 2.0 g/dL (i.e., &lt;-2 and &gt;2) categories were provided.</description>
          <population>ITT Population. Data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;= -2.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; -2.0 and &lt;= -1.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; -1.0 and &lt;= 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 0 and &lt;= 1.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 1.0 and &lt;= 2.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 2.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>within +/- 1.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>over +/- 2.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Daprodustat Dose Level by Visit</title>
        <description>Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Daprodustat. Median along with the interquartile range (25th and 75th percentile) has been presented.</description>
        <time_frame>Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44, and 48)</time_frame>
        <population>ITT Population. Only those participants available at the specified 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 oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Daprodustat Dose Level by Visit</title>
          <description>Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Daprodustat. Median along with the interquartile range (25th and 75th percentile) has been presented.</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).</population>
          <units>milligrams per day (mg/day)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, n=133</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="4.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, n=133</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="4.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, n=126</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="4.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, n=125</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="4.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16, n=123</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="4.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20, n=123</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="4.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, n=123</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="4.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28, n=123</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="4.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32, n=122</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="4.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, n=121</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="4.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40, n=119</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="4.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44, n=117</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="4.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, n=117</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="4.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distribution of Darbepoetin Alfa Dose Level by Visit</title>
        <description>Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Darbepoetin Alfa. Median along with the interquartile range (25th and 75th percentile) has been presented.</description>
        <time_frame>Day 1, Weeks 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32,34,36,38,40,42,44,46,48, and 50</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Darbepoetin Alfa</title>
            <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Distribution of Darbepoetin Alfa Dose Level by Visit</title>
          <description>Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Darbepoetin Alfa. Median along with the interquartile range (25th and 75th percentile) has been presented.</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).</population>
          <units>micrograms per week (ug/week)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, n=134</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="15.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2. n=134</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="15.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, n=134</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6, n=133</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, n=131</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10, n=129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, n=129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14, n=129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16, n=129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18, n=129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20, n=129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 22, n=128</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, n=129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26, n=129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28, n=127</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 30, n=128</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32, n=127</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 34, n=127</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, n=127</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 38, n=127</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40, n=125</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 42, n=125</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44, n=125</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 46, n=125</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, n=124</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 50, n=122</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Treatment Interruption Due to Hgb &gt;13 g/dL</title>
        <description>Duration of treatment interruption due to Hgb &gt;13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for the daprodustat group.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population. Only those participants with data available at the time of assessment were used for analysis. Summary data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency. Median along with inter quartile range (25th and 75th percentile) have been presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Treatment Interruption Due to Hgb &gt;13 g/dL</title>
          <description>Duration of treatment interruption due to Hgb &gt;13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for the daprodustat group.</description>
          <population>ITT Population. Only those participants with data available at the time of assessment were used for analysis. Summary data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency. Median along with inter quartile range (25th and 75th percentile) have been presented.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0" lower_limit="28.0" upper_limit="56.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Dose Adjustments for Daprodustat</title>
        <description>Number of dose adjustments has been presented only for daprodustat.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population. Summary data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Dose Adjustments for Daprodustat</title>
          <description>Number of dose adjustments has been presented only for daprodustat.</description>
          <population>ITT Population. Summary data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency.</population>
          <units>Dose adjustments</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="0" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hgb Values at Each Assessment Visit</title>
        <description>Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.</description>
        <time_frame>Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52</time_frame>
        <population>ITT Population. Only those participants available at the specified 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 oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Hgb Values at Each Assessment Visit</title>
          <description>Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1), n=133, 134</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.94" spread="0.770"/>
                    <measurement group_id="O2" value="10.82" spread="0.732"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, n=133, 134</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.52" spread="0.984"/>
                    <measurement group_id="O2" value="10.90" spread="0.829"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, n=127, 132</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.50" spread="1.069"/>
                    <measurement group_id="O2" value="11.01" spread="0.824"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, n=125, 129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.53" spread="0.989"/>
                    <measurement group_id="O2" value="11.09" spread="0.753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16, n=124, 129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.57" spread="0.970"/>
                    <measurement group_id="O2" value="10.92" spread="0.862"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20, n=123, 129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.85" spread="0.784"/>
                    <measurement group_id="O2" value="10.95" spread="0.830"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, n=123, 129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.01" spread="0.718"/>
                    <measurement group_id="O2" value="10.92" spread="0.859"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28, n=123, 129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.97" spread="0.748"/>
                    <measurement group_id="O2" value="10.86" spread="0.872"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32, n=122, 127</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.10" spread="0.829"/>
                    <measurement group_id="O2" value="10.96" spread="0.820"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, n=121, 127</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="121"/>
                    <count group_id="O2" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.12" spread="0.827"/>
                    <measurement group_id="O2" value="10.91" spread="0.847"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40, n=120, 125</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.97" spread="0.860"/>
                    <measurement group_id="O2" value="10.90" spread="0.835"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44, n=117, 125</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.98" spread="0.912"/>
                    <measurement group_id="O2" value="10.87" spread="0.904"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, n=117, 124</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.94" spread="0.893"/>
                    <measurement group_id="O2" value="10.76" spread="0.830"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52,n=115, 120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="115"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.79" spread="0.807"/>
                    <measurement group_id="O2" value="10.79" spread="0.841"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hgb Values at Each Assessment Visit</title>
        <description>Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calcuated as the post-dose visit value minus the Baseline value. Change from Baseline Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.</description>
        <time_frame>Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52</time_frame>
        <population>ITT Population. Only those participants available at the specified 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 oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hgb Values at Each Assessment Visit</title>
          <description>Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calcuated as the post-dose visit value minus the Baseline value. Change from Baseline Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4, n=133, 134</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.42" spread="0.898"/>
                    <measurement group_id="O2" value="0.08" spread="0.525"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, n=127, 132</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.45" spread="1.178"/>
                    <measurement group_id="O2" value="0.20" spread="0.821"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, n=125, 129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.42" spread="1.258"/>
                    <measurement group_id="O2" value="0.27" spread="1.021"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16, n=124, 129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.38" spread="1.348"/>
                    <measurement group_id="O2" value="0.09" spread="1.146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20, n=123, 129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="1.161"/>
                    <measurement group_id="O2" value="0.12" spread="1.120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, n=123, 129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="1.106"/>
                    <measurement group_id="O2" value="0.10" spread="1.068"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28, n=123, 129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="1.084"/>
                    <measurement group_id="O2" value="0.04" spread="1.080"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32, n=122, 127</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="1.119"/>
                    <measurement group_id="O2" value="0.14" spread="1.071"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, n=121, 127</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="121"/>
                    <count group_id="O2" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="1.020"/>
                    <measurement group_id="O2" value="0.09" spread="1.041"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40, n=120, 125</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="1.060"/>
                    <measurement group_id="O2" value="0.10" spread="1.034"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44, n=117, 125</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="1.118"/>
                    <measurement group_id="O2" value="0.07" spread="1.019"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, n=117, 124</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="1.164"/>
                    <measurement group_id="O2" value="-0.04" spread="0.978"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52,n=115, 120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="115"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.16" spread="1.169"/>
                    <measurement group_id="O2" value="0.01" spread="1.019"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) at Each Assessment Visit</title>
        <description>Percentage of participants with Hgb within the target range was summarized at each assessment visit by treatment group have been presented.</description>
        <time_frame>Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52</time_frame>
        <population>ITT Population. Only those participants available at the specified 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 oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) at Each Assessment Visit</title>
          <description>Percentage of participants with Hgb within the target range was summarized at each assessment visit by treatment group have been presented.</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1), n=133, 134</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, n=133,134</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, n=127,132</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, n=125,129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16, n=124,129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20, n=123,129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, n=123,129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28, n=123,129</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32, n=122, 127</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, n=121,127</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="121"/>
                    <count group_id="O2" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40, n=120,125</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44, n=117,125</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, n=117,124</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                    <count group_id="O2" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52, n=115,120</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="115"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time in Hgb Target Range (10.0 to 12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)</title>
        <description>Percentage of time in Hgb target range (10.0 to 12.0 g/dL) during the primary efficacy evaluation period (Weeks 40 to 52) for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.</description>
        <time_frame>Weeks 40 to 52</time_frame>
        <population>ITT Population. Only those participants with data available at the indicated time point were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time in Hgb Target Range (10.0 to 12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)</title>
          <description>Percentage of time in Hgb target range (10.0 to 12.0 g/dL) during the primary efficacy evaluation period (Weeks 40 to 52) for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.</description>
          <population>ITT Population. Only those participants with data available at the indicated time point were analyzed.</population>
          <units>Percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.81" spread="30.387"/>
                    <measurement group_id="O2" value="80.23" spread="28.038"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Had an Hgb Level of Less Than 7.5 g/dL</title>
        <description>If an initial Hgb value was less than 7.5 g/dL, measurement was repeated at the same study visit (using the same sample) to calculate the average. If the average met the Hgb stopping criteria, study treatment was permanently discontinued. Number of participants who had an Hgb level of less than 7.5 g/dL 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 oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Had an Hgb Level of Less Than 7.5 g/dL</title>
          <description>If an initial Hgb value was less than 7.5 g/dL, measurement was repeated at the same study visit (using the same sample) to calculate the average. If the average met the Hgb stopping criteria, study treatment was permanently discontinued. Number of participants who had an Hgb level of less than 7.5 g/dL has been presented.</description>
          <population>ITT Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks</title>
        <description>Number of participants who had an Hgb increase of more than 2 g/dL over any 4 weeks for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have 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 oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks</title>
          <description>Number of participants who had an Hgb increase of more than 2 g/dL over any 4 weeks for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have 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="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Had an Hgb Level of More Than 13.0 g/dL</title>
        <description>Number of participants who had an Hgb increase of more than 13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have 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 oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Had an Hgb Level of More Than 13.0 g/dL</title>
          <description>Number of participants who had an Hgb increase of more than 13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented.</description>
          <population>ITT Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Episodes With Hgb Level of More Than 13.0 g/dL</title>
        <description>Number of episodes with Hgb level of more than 13.0 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have 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 oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Darbepoetin Alfa</title>
            <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Episodes With Hgb Level of More Than 13.0 g/dL</title>
          <description>Number of episodes with Hgb level of more than 13.0 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented.</description>
          <population>ITT Population</population>
          <units>Episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under Plasma Concentration Curve From Time Zero to 4 Hours (AUC [0 - 4]) of Plasma Daprodustat</title>
        <description>Blood samples for Pharmacokinetic (PK) analysis of daprodustat were collected as the time points provided. PK parameters were calculated by standard non-compartmental analysis according to current working practices and using the currently supported version of WinNonlin (version 6.3 or higher). NA indicates geometric co-efficient of variation could not be calculated as a single participant was analyzed. Data has been provided as a consolidated values for at all time-points (0,1,2,3,and 4 hours post-dose) as provided for a single value at Weeks 12 and 24 respectively. PK population comprised of all daprodustat-treated participants from whom PK samples were collected and analyzed. Data was not calculated for darbepoetin alfa group as the primary interest of analysis was Daprodustat and not comparator drug (darbepoetin alfa). Data is combined from Week 12 and Week 24 data.</description>
        <time_frame>0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under Plasma Concentration Curve From Time Zero to 4 Hours (AUC [0 - 4]) of Plasma Daprodustat</title>
          <description>Blood samples for Pharmacokinetic (PK) analysis of daprodustat were collected as the time points provided. PK parameters were calculated by standard non-compartmental analysis according to current working practices and using the currently supported version of WinNonlin (version 6.3 or higher). NA indicates geometric co-efficient of variation could not be calculated as a single participant was analyzed. Data has been provided as a consolidated values for at all time-points (0,1,2,3,and 4 hours post-dose) as provided for a single value at Weeks 12 and 24 respectively. PK population comprised of all daprodustat-treated participants from whom PK samples were collected and analyzed. Data was not calculated for darbepoetin alfa group as the primary interest of analysis was Daprodustat and not comparator drug (darbepoetin alfa). Data is combined from Week 12 and Week 24 data.</description>
          <population>PK Population</population>
          <units>Hours*nanograms per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 mg, n=8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.57" spread="147.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 mg, n=24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.52" spread="139.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 mg, n=91</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.68" spread="242.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 mg, n=61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.58" spread="238.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 mg, n=38</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="170.41" spread="136.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 mg, n=17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150.53" spread="176.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 mg, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="488.93" spread="89.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Concentration (Cmax) of Plasma Daprodustat</title>
        <description>Blood samples for PK analysis of daprodustat were collected as the time points provided. PK parameters were calculated by standard non-compartmental analysis according to current working practices and using the currently supported version of WinNonlin (version 6.3 or higher). Data has been provided as a consolidated values for at all time-points (0,1,2,3,and 4 hours post-dose) as provided for a single value at Weeks 12 and 24 respectively. Data was not calculated for darbepoetin alfa group as the primary interest of analysis was Daprodustat and not comparator drug (darbepoetin alfa). Data is combined from Week 12 and Week 24 data.</description>
        <time_frame>0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>Daprodustat</title>
            <description>Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Concentration (Cmax) of Plasma Daprodustat</title>
          <description>Blood samples for PK analysis of daprodustat were collected as the time points provided. PK parameters were calculated by standard non-compartmental analysis according to current working practices and using the currently supported version of WinNonlin (version 6.3 or higher). Data has been provided as a consolidated values for at all time-points (0,1,2,3,and 4 hours post-dose) as provided for a single value at Weeks 12 and 24 respectively. Data was not calculated for darbepoetin alfa group as the primary interest of analysis was Daprodustat and not comparator drug (darbepoetin alfa). Data is combined from Week 12 and Week 24 data.</description>
          <population>PK Population</population>
          <units>Nanograms per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 mg, n=8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.11" spread="105.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 mg, n=24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.16" spread="122.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 mg, n=91</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.45" spread="237.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 mg, n=61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.60" spread="269.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 mg, n=38</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105.71" spread="110.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 mg, n=17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.58" spread="117.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 mg, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="306.61" spread="61.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events and serious adverse events were collected from the start of study treatment until the follow-up contact (Day 1 up to Follow-up Visit [Week 54])</time_frame>
      <desc>Safety population that comprised of all participants who received at least one dose of study treatment were used for the assessment of serious adverse events and non-serious adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Daprodustat</title>
          <description>Participants received oral daprodustat tablets (1, 2, 4, 6, 8, 12, 18 and 24 milligrams [mg] as recommended) once daily and intravenous (IV) darbepoetin alfa placebo injection (0.5 milliliter prefilled syringes containing no darbepoetin alfa) once weekly for 52 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Darbepoetin Alfa</title>
          <description>Participant received IV darbepoetin alfa injection (10,15,20,30,40 and 60 micrograms [ug] as recommended) once weekly and oral daprodustat placebo tablets (small and large tablets containing no daprodustat) once daily for 52 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.0</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="0" subjects_at_risk="136"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="136"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Cardiac valve disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Duodenal perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Vessel puncture site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Enteritis infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Shunt infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Shunt stenosis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="136"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Shunt occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Shunt malfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Procedural hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Salivary gland neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Spondylitic myelopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Endometrial hyperplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pemphigoid</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</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="102" subjects_at_risk="136"/>
                <counts group_id="E2" subjects_affected="102" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="24" subjects_affected="20" subjects_at_risk="136"/>
                <counts group_id="E2" events="15" subjects_affected="12" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="20" subjects_affected="15" subjects_at_risk="136"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="136"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="136"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="136"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="136"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="110" subjects_affected="57" subjects_at_risk="136"/>
                <counts group_id="E2" events="135" subjects_affected="73" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="136"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="136"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Shunt stenosis</sub_title>
                <counts group_id="E1" events="30" subjects_affected="16" subjects_at_risk="136"/>
                <counts group_id="E2" events="28" subjects_affected="15" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="21" subjects_affected="17" subjects_at_risk="136"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="14" subjects_affected="10" subjects_at_risk="136"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Procedural hypotension</sub_title>
                <counts group_id="E1" events="16" subjects_affected="11" subjects_at_risk="136"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="136"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="136"/>
                <counts group_id="E2" events="13" subjects_affected="10" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="136"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="136"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="136"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="135"/>
              </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/NCT02969655
org study id: 201754
nct id: NCT02969655
lead sponsor: 
has dmc: No
Daprodustat is a drug that is currently being developed as a treatment for renal anemia .
      This study is to evaluate the efficacy and safety of daprodustat following a switch from
      erythropoiesis-stimulating agent (ESA) in Japanese HD subjects with renal anemia who are
      currently treated with ESA. The primary objective is to demonstrate non-inferiority of
      daprodustat to darbepoetin alfa. This study is a 52-week, Phase III, double-blind,
      active-controlled, parallel-group, multi-center study. The total duration of the study will
      be approximately 58 weeks including screening and follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)
time frame: Weeks 40 to 52
description: The mean hemoglobin during the Evaluation Period was estimated by a statistical model.
measure: Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)
time frame: Weeks 40 to 52
description: The percentage of participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized. Odds ratio was estimated using a logistic regression and provided along with its 95% CI and a one-sided p-value.
measure: Change From Baseline in Hgb (Hgb Increase Rate) at Week 4
time frame: Baseline and Week 4
description: Change from Baseline was calculated as the post-dose Week 4 visit value minus the Baseline value.
measure: Percentage of Participants by Hgb Change From Baseline Category at Week 4
time frame: Week 4
description: Percentage of participants within each category were provided only for daprodustat and the categories were classified into 6 (i.e., <=-2, >-2 to -1, >-1 to 0, >0 to 1, >1 to 2, >2 grams per deciliter [g/dL]). In addition, 'within 1.0 g/dL (i.e., <=-1 and >=1) and over 2.0 g/dL (i.e., <-2 and >2) categories were provided.
measure: Distribution of Daprodustat Dose Level by Visit
time frame: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44, and 48)
description: Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Daprodustat. Median along with the interquartile range (25th and 75th percentile) has been presented.
measure: Distribution of Darbepoetin Alfa Dose Level by Visit
time frame: Day 1, Weeks 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32,34,36,38,40,42,44,46,48, and 50
description: Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Darbepoetin Alfa. Median along with the interquartile range (25th and 75th percentile) has been presented.
measure: Duration of Treatment Interruption Due to Hgb >13 g/dL
time frame: Up to Week 52
description: Duration of treatment interruption due to Hgb >13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for the daprodustat group.
measure: Number of Dose Adjustments for Daprodustat
time frame: Up to Week 52
description: Number of dose adjustments has been presented only for daprodustat.
measure: Hgb Values at Each Assessment Visit
time frame: Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
description: Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.
measure: Change From Baseline in Hgb Values at Each Assessment Visit
time frame: Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
description: Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calcuated as the post-dose visit value minus the Baseline value. Change from Baseline Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.
measure: Percentage of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) at Each Assessment Visit
time frame: Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52
description: Percentage of participants with Hgb within the target range was summarized at each assessment visit by treatment group have been presented.
measure: Percentage of Time in Hgb Target Range (10.0 to 12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)
time frame: Weeks 40 to 52
description: Percentage of time in Hgb target range (10.0 to 12.0 g/dL) during the primary efficacy evaluation period (Weeks 40 to 52) for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.
measure: Number of Participants Who Had an Hgb Level of Less Than 7.5 g/dL
time frame: Up to Week 52
description: If an initial Hgb value was less than 7.5 g/dL, measurement was repeated at the same study visit (using the same sample) to calculate the average. If the average met the Hgb stopping criteria, study treatment was permanently discontinued. Number of participants who had an Hgb level of less than 7.5 g/dL has been presented.
measure: Number of Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
time frame: Up to Week 52
description: Number of participants who had an Hgb increase of more than 2 g/dL over any 4 weeks for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented.
measure: Number of Participants Who Had an Hgb Level of More Than 13.0 g/dL
time frame: Up to Week 52
description: Number of participants who had an Hgb increase of more than 13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented.
measure: Number of Episodes With Hgb Level of More Than 13.0 g/dL
time frame: Up to Week 52
description: Number of episodes with Hgb level of more than 13.0 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented.
measure: Area Under Plasma Concentration Curve From Time Zero to 4 Hours (AUC [0 - 4]) of Plasma Daprodustat
time frame: 0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24
description: Blood samples for Pharmacokinetic (PK) analysis of daprodustat were collected as the time points provided. PK parameters were calculated by standard non-compartmental analysis according to current working practices and using the currently supported version of WinNonlin (version 6.3 or higher). NA indicates geometric co-efficient of variation could not be calculated as a single participant was analyzed. Data has been provided as a consolidated values for at all time-points (0,1,2,3,and 4 hours post-dose) as provided for a single value at Weeks 12 and 24 respectively. PK population comprised of all daprodustat-treated participants from whom PK samples were collected and analyzed. Data was not calculated for darbepoetin alfa group as the primary interest of analysis was Daprodustat and not comparator drug (darbepoetin alfa). Data is combined from Week 12 and Week 24 data.
measure: Maximum Concentration (Cmax) of Plasma Daprodustat
time frame: 0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24
description: Blood samples for PK analysis of daprodustat were collected as the time points provided. PK parameters were calculated by standard non-compartmental analysis according to current working practices and using the currently supported version of WinNonlin (version 6.3 or higher). Data has been provided as a consolidated values for at all time-points (0,1,2,3,and 4 hours post-dose) as provided for a single value at Weeks 12 and 24 respectively. Data was not calculated for darbepoetin alfa group as the primary interest of analysis was Daprodustat and not comparator drug (darbepoetin alfa). Data is combined from Week 12 and Week 24 data.
arm group label: Daprodustat
arm group type: Experimental
description: Subjects will receive oral daprodustat once daily and intravenous (IV) darbepoetin alfa placebo once weekly for 52 weeks
arm group label: Darbepoetin alfa
arm group type: Active Comparator
description: Subjects will receive IV darbepoetin alfa once weekly and oral daprodustat placebo once daily for 52 weeks
intervention type: Drug
intervention name: Daprodustat small
description: Available as 7.0 millimeter (mm) round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, or 4 mg of daprodustat as active ingredient
arm group label: Daprodustat
intervention type: Drug
intervention name: Daprodustat small placebo
description: Available as 7.0 mm round, standard biconvex, white film coated tablets containing no daprodustat
arm group label: Darbepoetin alfa
intervention type: Drug
intervention name: Daprodustat large
description: Available as 9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of daprodustat as active ingredient
arm group label: Daprodustat
intervention type: Drug
intervention name: Daprodustat large placebo
description: Available as 9.0 mm round, standard biconvex, white film coated tablets containing no daprodustat
arm group label: Darbepoetin alfa
intervention type: Drug
intervention name: Darbepoetin alfa
description: Available as 0.5 mL plastic prefilled syringes (PFS) for IV injection each containing 10, 15, 20, 30, 40 or 60 mcg of darbepoetin alfa in a clear and colorless solution.
arm group label: Darbepoetin alfa
intervention type: Drug
intervention name: Darbepoetin alfa placebo
description: Available as 0.5 mL plastic PFS for IV injection containing no darbepoetin alfa in a clear and colorless solution.
arm group label: Daprodustat
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
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: 
country: Japan
citation: Akizawa T, Nangaku M, Yonekawa T, Okuda N, Kawamatsu S, Onoue T, Endo Y, Hara K, Cobitz AR. Efficacy and Safety of Daprodustat Compared with Darbepoetin Alfa in Japanese Hemodialysis Patients with Anemia: A Randomized, Double-Blind, Phase 3 Trial. Clin J Am Soc Nephrol. 2020 Aug 7;15(8):1155-1165. doi: 10.2215/CJN.16011219. Epub 2020 Jul 28.
PMID: 32723804
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Anemia
mesh term: Darbepoetin alfa
mesh term: Glycine
sharing ipd: Yes
ipd description: IPD for this study is 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 is available via the Clinical Study Data Request site (copy the URL below to your browser)
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: https://www.clinicalstudydatarequest.com/Posting.aspx?ID=20737
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 