<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/NCT02243306</url>
  </required_header>
  <id_info>
    <org_study_id>200942</org_study_id>
    <secondary_id>2014-001197-34</secondary_id>
    <nct_id>NCT02243306</nct_id>
  </id_info>
  <brief_title>Study to Assess the Pharmacokinetics of GSK1278863 in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis</brief_title>
  <official_title>A Repeat-Dose, Open-Label, Parallel-Group Study to Assess the Pharmacokinetics of GSK1278863 and Metabolites in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis</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>
      GSK1278863 is an orally-active, novel small molecule agent which inhibits hypoxia-inducible&#xD;
      factor (HIF) prolyl -4- hydroxylases (PHDs) and is in development for the treatment of&#xD;
      anaemia associated with chronic kidney disease (CKD). As the kidney represents a major site&#xD;
      of elimination for many drugs and their metabolites, and GSK1278863 will be administered to&#xD;
      subjects with various stages of renal disease, it is important to characterize the&#xD;
      pharmacokinetics in this target patient population. The purpose of this study is to&#xD;
      characterize the pharmacokinetics of GSK1278863 and its metabolites in subjects with end&#xD;
      stage renal disease (ESRD) undergoing peritoneal dialysis. This will be a repeat-dose,&#xD;
      open-label, parallel-group study. Approximately 30 subjects with ESRD will be enrolled in two&#xD;
      cohorts (15 subjects in each cohort) to ensure that 6 subjects on continuous ambulatory&#xD;
      peritoneal dialysis (CAPD) (cohort 1) and 6 subjects on automated peritoneal dialysis APD&#xD;
      (cohort 2) complete dosing and critical assessments. GSK1278863 will be administered once&#xD;
      daily for 14 days. Primary pharmacokinetic assessments will be made on Days 1 and 14.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2014</start_date>
  <completion_date type="Actual">May 10, 2017</completion_date>
  <primary_completion_date type="Actual">May 10, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites</measure>
    <time_frame>Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14</time_frame>
    <description>Serial blood samples were collected from participants at indicated time points for Pharmacokinetic (PK) analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. PK Population comprised of participants in the 'All Subjects' Population for whom a PK sample was obtained and analyzed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-inf]) of GSK1278863 and Its Metabolites</measure>
    <time_frame>Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1</time_frame>
    <description>Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2487818 and GSK2531398). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Concentration (Cmax) of GSK1278863 and Its Metabolites</measure>
    <time_frame>Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14</time_frame>
    <description>Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)</measure>
    <time_frame>Up to Day 24</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations, and is associated with liver injury and impaired liver function. Analysis was performed on All Subjects Population which comprised of all enrolled participants who received at least one dose of study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Glucose, Calcium, Chloride, Carbon-dioxide (CO2), Potassium, Sodium and Urea Levels</measure>
    <time_frame>Baseline and Day 17</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including glucose, calcium, chloride, CO2, potassium, sodium and urea. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Albumin and Protein Levels</measure>
    <time_frame>Baseline and Day 17</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including albumin and protein. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Direct Bilirubin, Bilirubin, Creatinine and Urate Levels</measure>
    <time_frame>Baseline and Day 17</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including direct bilirubin, bilirubin, creatinine and urate. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Aminotransferase (GGT) Levels</measure>
    <time_frame>Baseline and Day 17</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including ALP, AST and GGT. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Alanine Aminotransferase (ALT) and Creatinine Kinase Levels</measure>
    <time_frame>Baseline and Day 3, 7, 11, 14, 17</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including ALT and creatinine kinase. Change from Baseline in clinical chemistry parameters at Day 3, Day 7, Day 11, Day 14 and Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Levels</measure>
    <time_frame>Baseline and Day 17</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. NA indicates data is not available. Mean and standard deviation are presented. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Erythrocyte and Reticulocyte Levels</measure>
    <time_frame>Baseline and Day 17</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical hematology parameters including erythrocyte and reticulocyte. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. NA indicates data is not available. Mean and standard deviation are presented. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hematocrit Levels</measure>
    <time_frame>Baseline and Day 17</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical hematology parameters including hematocrit. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hemoglobin Levels</measure>
    <time_frame>Baseline and Day 3, 7, 11, 17</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical hematology parameters including hemoglobin. Change from Baseline in clinical hematology parameters at Day 3, Day 7, Day 11 and Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Corpuscular Hemoglobin Concentration (MCHC)</measure>
    <time_frame>Baseline and Day 17</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical hematology parameters including MCHC. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Corpuscular Volume (MCV)</measure>
    <time_frame>Baseline and Day 17</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical hematology parameters including MCV. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Corpuscular Hemoglobin (MCH) Levels</measure>
    <time_frame>Baseline and Day 17</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical hematology parameters including MCH. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Electrocardiogram (ECG) Findings</measure>
    <time_frame>Day 17</time_frame>
    <description>Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) interval. Participants with abnormal ECG findings at worst-case observation Carried Forward for triplicate measurements (WOCF) post-Baseline visit are presented. Only participants with data available at WOCF visit were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</measure>
    <time_frame>Baseline, Day 17 and Day 24</time_frame>
    <description>Vital sign measurements including SBP and DBP were taken in a supine position after at least 5 minutes of rest. Change from Baseline in SBP and DBP at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pulse Rate</measure>
    <time_frame>Baseline, Day 17 and Day 24</time_frame>
    <description>Vital sign measurements including pulse rate were taken in a supine position after at least 5 minutes of rest. Change from Baseline in pulse rate at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Temperature</measure>
    <time_frame>Baseline, Day 17 and Day 24</time_frame>
    <description>Vital sign measurements including body temperature were taken in a supine position after at least 5 minutes of rest. Change from Baseline in body temperature at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Physical Examination Findings</measure>
    <time_frame>Up to Day 17</time_frame>
    <description>A complete physical examination was planned to include assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. This analysis was planned but not performed. Any significant finding was captured as an AE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peritoneal Dialysis Clearance of GSK1278863 and Metabolites</measure>
    <time_frame>Day 14</time_frame>
    <description>Peritoneal dialysate samples for PK analysis of GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) were collected. Peritoneal dialysis clearance of GSK1278863 and metabolites was calculated from Day 14 dialysate excretion data as total amount of analyte excreted over 24 hours divided by plasma AUC (0-tau). Geometric mean and geometric coefficient of variation are presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Phase Half-life (t 1/2) of GSK1278863 and Metabolites</measure>
    <time_frame>Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14</time_frame>
    <description>Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403, GSK2531401). Geometric mean and geometric coefficient of variation have been presented for all metabolites. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants, which is indicated by NA. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Occurrence of Cmax (Tmax) of GSK1278863 and Metabolites</measure>
    <time_frame>Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14</time_frame>
    <description>Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Median and full range have been presented for all metabolites. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation Ratio of GSK1278863 and Metabolites</measure>
    <time_frame>Day 1 and Day 14</time_frame>
    <description>The observed accumulation ratio was determined to estimate the extent of accumulation for GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) after repeat dosing. Accumulation ratio was calculated by using AUC (0-tau) values at Day 1 and Day 14. Analysis was performed using mixed effect model fitted with day (single and repeat dose) as fixed effect and participant as random effect. Mean ratio and 90% confidence intervals have been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Invariance Ratio of GSK1278863 and Metabolites</measure>
    <time_frame>Day 1 and Day 14</time_frame>
    <description>Time invariance ratio for GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) was calculated by analyzing AUC (0-inf) at Day 1 and AUC (0-tau) at Day 14. Analysis was performed using mixed effect model fitted with day (single and repeat dose) as fixed effect and participant as random effect. Mean ratio and 90% confidence intervals have been presented. NA indicates data is not available. Data could not be calculated due to insufficient data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentration of Erythropoietin</measure>
    <time_frame>Pre-dose and 4, 8 ,12, 24 hours post-dose on Day 1 and Day 14; Pre-dose on Day 3, 7, 11</time_frame>
    <description>Serial blood samples were collected from participants at indicated time points to analyze plasma concentration of erythropoietin after repeat-dose administration of GSK1278863. Geometric mean and geometric coefficient of variation have been presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentration of Hepcidin</measure>
    <time_frame>Pre-dose and 4, 8 ,12, 24 hours post-dose on Day 1 and Day 14; Pre-dose on Day 3, 7, 11</time_frame>
    <description>Serial blood samples were collected from participants at indicated time points to analyze plasma concentration of hepcidin after repeat-dose administration of GSK1278863. Geometric mean and geometric coefficient of variation have been presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Anaemia</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects on continuous ambulatory peritoneal dialysis (CAPD) will receive 5 mg of GSK1278863 orally, once daily for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects on automated peritoneal dialysis (APD) will receive 5 mg of GSK1278863 orally, once daily for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GSK1278863</intervention_name>
    <description>Round, biconvex, white film coated tablet containing 5 mg GSK1278863.</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        SAFETY:&#xD;
&#xD;
          -  Satisfactory medical evaluation based upon medical history, medication history,&#xD;
             physical examination, and clinical laboratory data obtained at the Screening visit.&#xD;
             The determination of clinical significance will be made by the Investigator and the&#xD;
             GlaxoSmithKline (GSK) Medical Monitor and will require that the finding is unlikely to&#xD;
             introduce additional risk factors or interfere with the study procedures, or the&#xD;
             integrity of the study.&#xD;
&#xD;
          -  Corrected QT interval (QTc) &lt;470 milliseconds (msec) OR QTc &lt;480 msec in subjects with&#xD;
             Bundle Branch Block. These should be based on average of triplicate values obtained&#xD;
             over a brief recording period at Screening and on Day -1 and the single reading on Day&#xD;
             17. The same QT correction formula should be used to determine inclusion and&#xD;
             discontinuation for any individual subject throughout the study.&#xD;
&#xD;
          -  Vitamin B12 and folate above the lower limit of normal at Screening.&#xD;
&#xD;
          -  Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), and bilirubin &lt;=1.5&#xD;
             x upper limit of normal (ULN) (isolated bilirubin &gt;1.5xULN is acceptable if bilirubin&#xD;
             is fractionated and direct bilirubin &lt;35%).&#xD;
&#xD;
        EFFICACY:&#xD;
&#xD;
          -  A subject is eligible to enroll and participate in this study if he/she has ESRD and&#xD;
             is on peritoneal dialysis for at least 2 months with an average urine output of &lt;750&#xD;
             mL/daily with a combined weekly (urine and peritoneal dialysis output) Kt/V urea &gt;1.7&#xD;
             measured at any time within last 3 months.&#xD;
&#xD;
          -  No history of peritoneal dialysis-associated peritonitis, peritoneal catheter tunnel&#xD;
             (exit site) infection or leakage for at least 3 months before study.&#xD;
&#xD;
          -  Meets the following erythropoiesis stimulating agent (ESA) criteria: Is ESA naive&#xD;
             (i.e., no ESA use within the previous 12 weeks of screening) OR agrees to discontinue&#xD;
             ESA (if currently using ESA) for at least 7 days prior to first dose of GSK1278863&#xD;
             until completion of Follow-up visit (If the subject has a scheduled ESA interval which&#xD;
             is &lt;=7 days, ESA treatment must be discontinued for at least 7 days prior to first&#xD;
             dose of GSK1278863. If the subject has a scheduled ESA interval which is &gt;7 days, ESA&#xD;
             treatment must be discontinued for at least the scheduled interval length [e.g., if&#xD;
             ESA interval is 14 days, then ESA must be discontinued for &gt;=14 days] prior to the&#xD;
             first dose of GSK1278863)&#xD;
&#xD;
          -  Has a haemoglobin value: For ESA naïve subjects: &lt;10.0 g/dL (UK site(s) only: &lt;=11.0&#xD;
             g/dL); For subjects receiving ongoing ESA treatment: &lt;=11.0 g/dL at Screening (UK&#xD;
             site(s) only: &lt;=12.0 g/dL at Screening).&#xD;
&#xD;
        OTHER:&#xD;
&#xD;
          -  Subjects who are &gt;=18 years of age at the time of Screening.&#xD;
&#xD;
          -  A female subject is eligible to participate if she is of: (a) Childbearing potential,&#xD;
             and agrees to use one of the contraception methods described in the protocol. This&#xD;
             criterion must be followed from the time of Screening until completion of the&#xD;
             Follow-up Visit; (b) Non-childbearing potential, defined as pre-menopausal females&#xD;
             with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12&#xD;
             months of spontaneous amenorrhea (In questionable cases, a blood sample with&#xD;
             simultaneous follicle stimulating hormone (FSH) 23.0-116.3 international units&#xD;
             (IU)/litre (L) and estradiol &lt;=10 picograms (pg)/mL (or &lt;=37 picomoles [pmol]/L) is&#xD;
             confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal&#xD;
             status is in doubt will be required to use one of the contraception methods described&#xD;
             in the protocol if they wish to continue their HRT during the study. Otherwise, they&#xD;
             must discontinue HRT to allow confirmation of post-menopausal status prior to study&#xD;
             enrollment. For most forms of HRT, at least 2 months must elapse between the cessation&#xD;
             of therapy and the blood draw; this interval depends on the type and dosage of HRT.&#xD;
             Following confirmation of their post-menopausal status, they can resume use of HRT&#xD;
             during the study without use of a contraceptive method.&#xD;
&#xD;
          -  Body weight &gt;45 kilograms (kg) and &lt;140 kg at Screening.&#xD;
&#xD;
          -  The subject is mentally and legally able to comply with the requirements and&#xD;
             restrictions of the protocol and has provided signed informed consent prior to&#xD;
             participation in any protocol-specific procedures, including Screening procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        SAFETY&#xD;
&#xD;
          -  A positive test for Human Immunodeficiency Virus (HIV) antibody.&#xD;
&#xD;
          -  Uncontrolled hypertension (diastolic blood pressure [BP] &gt;100 millimetres of mercury&#xD;
             [mmHg] or systolic BP &gt;170 mmHg) at Screening.&#xD;
&#xD;
          -  History of drug abuse or dependence within 6 months of the study.&#xD;
&#xD;
          -  History of sensitivity to GSK1278863, or its components thereof or a history of drug&#xD;
             or other allergy that, in the opinion of the Investigator or GSK Medical Monitor,&#xD;
             contraindicates their participation.&#xD;
&#xD;
          -  History of sensitivity to heparin or heparin-induced thrombocytopenia (if the clinical&#xD;
             research unit uses heparin to maintain intravenous cannula patency).&#xD;
&#xD;
          -  History of thrombosis defined as deep vein thrombosis, stroke, pulmonary embolism or&#xD;
             other thrombosis related condition within 3 months prior to Screening.&#xD;
&#xD;
          -  History of myocardial infarction or acute coronary syndrome within 3 months prior to&#xD;
             Screening.&#xD;
&#xD;
          -  History of stroke or transient ischaemic attack within 3 months prior to Screening.&#xD;
&#xD;
          -  Subjects with a pre-existing condition interfering with normal gastrointestinal&#xD;
             anatomy or motility, and/or hepatic function that could interfere with the absorption,&#xD;
             metabolism, and/or excretion of GSK1278863. Examples of conditions that could&#xD;
             interfere with normal gastrointestinal anatomy or motility include gastrointestinal&#xD;
             bypass surgery, partial or total gastrectomy, small bowel resection, vagotomy,&#xD;
             malabsorption, Crohn's disease, ulcerative colitis, or celiac sprue. Examples of&#xD;
             conditions that could interfere with hepatic function include Gilbert's syndrome.&#xD;
&#xD;
          -  Evidence of active peptic, duodenal or esophageal ulcer disease at Screening OR&#xD;
             history of clinically significant gastro-intestinal (GI) bleeding within 3 months&#xD;
             prior to Screening.&#xD;
&#xD;
          -  Subjects with chronic inflammatory disease that could impact erythropoiesis (e.g.&#xD;
             scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease).&#xD;
&#xD;
          -  Subjects with a history of symptomatic right heart failure.&#xD;
&#xD;
          -  Subjects with Class III or Class IV heart failure, as defined by the New York Heart&#xD;
             Association (NYHA) functional classification system.&#xD;
&#xD;
          -  Active malignancy or diagnosis of malignancy within 5 years prior to Screening&#xD;
             (excluding successfully treated basal or squamous cell carcinoma).&#xD;
&#xD;
          -  History of proliferative vascular eye disease (e.g., choroidal or retinal disease,&#xD;
             such as neovascular age-related macular degeneration, proliferative diabetic&#xD;
             retinopathy or macular edema) based upon having had an ophthalmologic exam within 12&#xD;
             months prior to the end of the Screening period (The screening period is from the&#xD;
             screening visit until Day -1).&#xD;
&#xD;
          -  Pregnant females as determined by positive serum human chorionic gonadotropin (hCG)&#xD;
             test at Screening or Day -1.&#xD;
&#xD;
          -  Lactating females.&#xD;
&#xD;
          -  Where participation in the study would result in donation of blood or blood products&#xD;
             in excess of 500 mL within a 56 day period prior to first dose.&#xD;
&#xD;
          -  Consumption of red wine, grapefruit (juice), blood orange (juice), star fruit, onions,&#xD;
             kale, broccoli, green beans, or apples from 7 days prior to the first dose of&#xD;
             investigational product until the Follow-up visit, unless in the opinion of the&#xD;
             Investigator and GSK Medical Monitor this will not interfere with the study procedures&#xD;
             and compromise subject safety.&#xD;
&#xD;
          -  Use or planned use of any prescription or non-prescription drugs that are prohibited&#xD;
             within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives&#xD;
             (whichever is longer) prior to the first dose of GSK1278863 until completion of the&#xD;
             follow-up visit, unless in the opinion of the Investigator and GSK Medical Monitor the&#xD;
             medication will not interfere with the study procedures or compromise subject safety.&#xD;
&#xD;
          -  The following medications are specifically prohibited for the duration of the study&#xD;
             (from Screening to the follow-up visit at the end of the study): Chronic use of&#xD;
             non-steroidal anti-inflammatory drugs (NSAIDs) with the exception of low dose (&lt;=325&#xD;
             mg/day) aspirin/acetylsalicylic acid. Occasional NSAID use is permitted;&#xD;
             Immunosuppressant drugs and drugs used to treat malignancies (including&#xD;
             corticosteroids at doses &gt;10 mg prednisolone per day or equivalent) within 2 weeks of&#xD;
             first dose of GSK1278863. Note: Failed transplant subjects back on peritoneal dialysis&#xD;
             are eligible for participating in this study but should not be on immunosuppressive&#xD;
             medications within 3 months prior to Screening.&#xD;
&#xD;
          -  The subject has participated in a clinical trial and has received an experimental&#xD;
             investigational product within the following time period prior to the first dosing day&#xD;
             in the current study: 30 days, 5 half-lives or twice the duration of the biological&#xD;
             effect of the investigational product (whichever is longer).&#xD;
&#xD;
        EFFICACY:&#xD;
&#xD;
          -  The values of ferritin and transferrin within 3 months prior to Screening are: (a)&#xD;
             transferrin saturation &lt;20%; (b) serum ferritin &lt;100 micrograms (mcg)/L&#xD;
&#xD;
        OTHER:&#xD;
&#xD;
          -  A positive pre-dosing drug/alcohol screen. A minimum list of drugs that will be&#xD;
             screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and&#xD;
             benzodiazepines. A positive pre-dosing screen for medications that are prescribed to a&#xD;
             renal subject for pre-existing condition(s), may be allowed if in the opinion of the&#xD;
             Investigator and GSK Medical Monitor the medication will not interfere with the study&#xD;
             procedures or compromise subject safety.&#xD;
&#xD;
          -  History of regular alcohol consumption within 6 months of the study defined as an&#xD;
             average weekly intake of &gt;21 units for males or &gt;14 units for females. One unit is&#xD;
             equivalent to 8 g of alcohol: a half-pint (approximately240 mL) of beer, 1 glass (125&#xD;
             mL) of wine or 1 (25 mL) measure of spirits.&#xD;
&#xD;
          -  History of regular use within 6 months of the study of tobacco- or nicotine-containing&#xD;
             products in excess of 20 cigarettes per day or equivalent.&#xD;
&#xD;
          -  Unwillingness or inability to follow the procedures, or lifestyle and/or dietary&#xD;
             restrictions outlined in the informed consent and as directed by site staff.&#xD;
&#xD;
          -  Subject is either an immediate family member of a participating Investigator, study&#xD;
             coordinator, employee of an Investigator; or is a member of the staff conducting the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 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>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <reference>
    <citation>Caltabiano S, Cizman B, Burns O, Mahar KM, Johnson BM, Ramanjineyulu B, Serbest G, Cobitz AR. Effect of renal function and dialysis modality on daprodustat and predominant metabolite exposure. Clin Kidney J. 2019 Feb 18;12(5):693-701. doi: 10.1093/ckj/sfz013. eCollection 2019 Oct.</citation>
    <PMID>31583094</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>May 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>May 4, 2018</results_first_submitted>
  <results_first_submitted_qc>March 7, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 11, 2019</results_first_posted>
  <last_update_submitted>March 29, 2019</last_update_submitted>
  <last_update_submitted_qc>March 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pharmacokinetics</keyword>
  <keyword>Chronic kidney disease</keyword>
  <keyword>peritoneal dialysis</keyword>
  <keyword>hemoglobin</keyword>
  <keyword>Anemia</keyword>
  <keyword>GSK1278863</keyword>
  <keyword>Prolyl hydroxylase inhibitor</keyword>
  <keyword>erythropoiesis stimulating agents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 20, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT02243306/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT02243306/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This repeat-dose, pharmacokinetic (PK) study of GSK1278863 was conducted at two centers in the United States (US). Participants with End Stage Renal Disease (ESRD) undergoing continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) were included in this study.</recruitment_details>
      <pre_assignment_details>A total of 20 participants with ESRD were screened; of which 12 were screen failures and 8 entered the study to receive 5 milligrams (mg) of GSK1278863 once daily for 14 days.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Participants Undergoing CAPD</title>
          <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day 14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
        </group>
        <group group_id="P2">
          <title>Participants Undergoing APD</title>
          <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day 14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other: Reached stopping criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Participants Undergoing CAPD</title>
          <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
        </group>
        <group group_id="B2">
          <title>Participants Undergoing APD</title>
          <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</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="1"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age is calculated based on screening date, using date of birth, truncated to integer value.</description>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.0" spread="NA">Standard deviation could not be calculated for CAPD arm due to low number of participants</measurement>
                    <measurement group_id="B2" value="57.4" spread="12.01"/>
                    <measurement group_id="B3" value="55.8" spread="12.09"/>
                  </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="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race customized</title>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White- White/Caucasian/European Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites</title>
        <description>Serial blood samples were collected from participants at indicated time points for Pharmacokinetic (PK) analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. PK Population comprised of participants in the 'All Subjects' Population for whom a PK sample was obtained and analyzed.</description>
        <time_frame>Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14</time_frame>
        <population>PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites</title>
          <description>Serial blood samples were collected from participants at indicated time points for Pharmacokinetic (PK) analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. PK Population comprised of participants in the 'All Subjects' Population for whom a PK sample was obtained and analyzed.</description>
          <population>PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
          <units>Hour into 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="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK1278863; Day 1; n=1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="184.9863" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="138.6511" spread="93.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK1278863; Day 14; n=1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162.9366" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="131.2826" spread="78.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220; Day 1; n=1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="245.8999" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="147.8039" spread="47.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220; Day 14; n=1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="258.1199" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="162.0324" spread="50.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818; Day 1; n=1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116.2608" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="67.4130" spread="39.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818; Day 14; n=1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114.1857" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="59.6501" spread="51.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102; Day 1; n=1,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.0619" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="44.8180" spread="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102; Day 14; n=1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.9794" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="65.2188" spread="63.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398; Day 1; n=1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0339" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="63.0979" spread="45.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398; Day 14; n=1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.6587" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="65.9664" spread="53.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531403; Day 1; n=1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="291.3067" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="170.4958" spread="45.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531403; Day 14; n=1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="360.2268" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="228.6081" spread="69.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401; Day 1; n=1, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="173.5919" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="104.2971" spread="48.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401; Day 14; n=1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="242.0514" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="205.7281" spread="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-inf]) of GSK1278863 and Its Metabolites</title>
        <description>Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2487818 and GSK2531398). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</description>
        <time_frame>Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-inf]) of GSK1278863 and Its Metabolites</title>
          <description>Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2487818 and GSK2531398). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</description>
          <population>PK Population</population>
          <units>Hour into 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="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK1278863</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="184.9888" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="138.6860" spread="93.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117.2111" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="68.5089" spread="39.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.5268" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="73.9865" spread="51.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Concentration (Cmax) of GSK1278863 and Its Metabolites</title>
        <description>Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
        <time_frame>Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14</time_frame>
        <population>PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax) of GSK1278863 and Its Metabolites</title>
          <description>Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
          <population>PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</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="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK1278863; Day 1; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.400" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="58.771" spread="96.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK1278863; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.800" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="30.303" spread="104.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220; Day 1; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.900" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="11.360" spread="44.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.500" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="10.966" spread="33.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818; Day 1; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.400" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="10.117" spread="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.400" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="7.262" spread="40.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102; Day 1; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.820" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="2.553" spread="42.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.050" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="3.590" spread="46.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398; Day 1; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.300" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="5.370" spread="44.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.220" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="4.857" spread="35.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531403; Day 1; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.600" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="11.186" spread="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531403; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.400" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="13.267" spread="48.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401; Day 1; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.920" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="4.715" spread="78.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.300" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="10.404" spread="17.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)</title>
        <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations, and is associated with liver injury and impaired liver function. Analysis was performed on All Subjects Population which comprised of all enrolled participants who received at least one dose of study treatment.</description>
        <time_frame>Up to Day 24</time_frame>
        <population>All subjects Population</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)</title>
          <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations, and is associated with liver injury and impaired liver function. Analysis was performed on All Subjects Population which comprised of all enrolled participants who received at least one dose of study treatment.</description>
          <population>All subjects Population</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non-serious AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <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>Change From Baseline in Glucose, Calcium, Chloride, Carbon-dioxide (CO2), Potassium, Sodium and Urea Levels</title>
        <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including glucose, calcium, chloride, CO2, potassium, sodium and urea. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
        <time_frame>Baseline and Day 17</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Glucose, Calcium, Chloride, Carbon-dioxide (CO2), Potassium, Sodium and Urea Levels</title>
          <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including glucose, calcium, chloride, CO2, potassium, sodium and urea. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
          <units>Millimoles per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Glucose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="0.27" spread="7.191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.360" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="0.040" spread="0.2026"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-1.3" spread="2.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="0.3" spread="5.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.45" spread="0.580"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-1.5" spread="3.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.50" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.38" spread="3.568"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Albumin and Protein Levels</title>
        <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including albumin and protein. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
        <time_frame>Baseline and Day 17</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Albumin and Protein Levels</title>
          <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including albumin and protein. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
          <units>Gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Albumin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-1.3" spread="3.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-2.0" spread="5.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Direct Bilirubin, Bilirubin, Creatinine and Urate Levels</title>
        <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including direct bilirubin, bilirubin, creatinine and urate. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
        <time_frame>Baseline and Day 17</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Direct Bilirubin, Bilirubin, Creatinine and Urate Levels</title>
          <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including direct bilirubin, bilirubin, creatinine and urate. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
          <units>Micromoles per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Direct bilirubin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.5" spread="1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="0.5" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.30" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-119.12" spread="312.679"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-25.0" spread="87.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Aminotransferase (GGT) Levels</title>
        <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including ALP, AST and GGT. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
        <time_frame>Baseline and Day 17</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Aminotransferase (GGT) Levels</title>
          <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including ALP, AST and GGT. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
          <units>International unit per liter (IU/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.5" spread="16.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-3.3" spread="3.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GGT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-6.3" spread="8.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Alanine Aminotransferase (ALT) and Creatinine Kinase Levels</title>
        <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including ALT and creatinine kinase. Change from Baseline in clinical chemistry parameters at Day 3, Day 7, Day 11, Day 14 and Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
        <time_frame>Baseline and Day 3, 7, 11, 14, 17</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Alanine Aminotransferase (ALT) and Creatinine Kinase Levels</title>
          <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including ALT and creatinine kinase. Change from Baseline in clinical chemistry parameters at Day 3, Day 7, Day 11, Day 14 and Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
          <units>IU/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT; Day 3; n= 1, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.7" spread="3.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Day 7; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-2.5" spread="5.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Day 11; 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-3.5" spread="5.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.8" spread="3.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Day 17; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-1.0" spread="6.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Day 3; n= 1, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-99.7" spread="161.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Day 7; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-137.8" spread="230.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Day 11; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-135.8" spread="273.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-183.5" spread="247.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Day 17; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-201.5" spread="191.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Levels</title>
        <description>Blood samples were collected from participants to evaluate clinical hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. NA indicates data is not available. Mean and standard deviation are presented. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
        <time_frame>Baseline and Day 17</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Levels</title>
          <description>Blood samples were collected from participants to evaluate clinical hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. NA indicates data is not available. Mean and standard deviation are presented. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
          <units>10^9 cells/liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Basophils</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.020" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="0.010" spread="0.0200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.010" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="0.060" spread="0.0804"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.260" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.138" spread="0.3974"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.230" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="0.060" spread="0.3389"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.350" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.365" spread="1.1957"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-21.0" spread="35.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.80" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.35" spread="1.008"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Erythrocyte and Reticulocyte Levels</title>
        <description>Blood samples were collected from participants to evaluate clinical hematology parameters including erythrocyte and reticulocyte. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. NA indicates data is not available. Mean and standard deviation are presented. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
        <time_frame>Baseline and Day 17</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Erythrocyte and Reticulocyte Levels</title>
          <description>Blood samples were collected from participants to evaluate clinical hematology parameters including erythrocyte and reticulocyte. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. NA indicates data is not available. Mean and standard deviation are presented. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
          <units>10^12 cells/liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Erythrocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.05" spread="0.412"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reticulocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02840" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.00165" spread="0.044431"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hematocrit Levels</title>
        <description>Blood samples were collected from participants to evaluate clinical hematology parameters including hematocrit. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
        <time_frame>Baseline and Day 17</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hematocrit Levels</title>
          <description>Blood samples were collected from participants to evaluate clinical hematology parameters including hematocrit. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
          <units>Proportion of red blood cells in blood</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0070" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.0100" spread="0.03880"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hemoglobin Levels</title>
        <description>Blood samples were collected from participants to evaluate clinical hematology parameters including hemoglobin. Change from Baseline in clinical hematology parameters at Day 3, Day 7, Day 11 and Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
        <time_frame>Baseline and Day 3, 7, 11, 17</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin Levels</title>
          <description>Blood samples were collected from participants to evaluate clinical hematology parameters including hemoglobin. Change from Baseline in clinical hematology parameters at Day 3, Day 7, Day 11 and Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="3.1" spread="11.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7; n= 1, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-2.2" spread="9.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11; n= 1, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-3.2" spread="8.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-1.3" spread="13.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Corpuscular Hemoglobin Concentration (MCHC)</title>
        <description>Blood samples were collected from participants to evaluate clinical hematology parameters including MCHC. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
        <time_frame>Baseline and Day 17</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Corpuscular Hemoglobin Concentration (MCHC)</title>
          <description>Blood samples were collected from participants to evaluate clinical hematology parameters including MCHC. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="6.3" spread="3.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Corpuscular Volume (MCV)</title>
        <description>Blood samples were collected from participants to evaluate clinical hematology parameters including MCV. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
        <time_frame>Baseline and Day 17</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Corpuscular Volume (MCV)</title>
          <description>Blood samples were collected from participants to evaluate clinical hematology parameters including MCV. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
          <units>Femtoliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-1.5" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Corpuscular Hemoglobin (MCH) Levels</title>
        <description>Blood samples were collected from participants to evaluate clinical hematology parameters including MCH. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
        <time_frame>Baseline and Day 17</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Corpuscular Hemoglobin (MCH) Levels</title>
          <description>Blood samples were collected from participants to evaluate clinical hematology parameters including MCH. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
          <units>Picograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.02" spread="0.866"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Electrocardiogram (ECG) Findings</title>
        <description>Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) interval. Participants with abnormal ECG findings at worst-case observation Carried Forward for triplicate measurements (WOCF) post-Baseline visit are presented. Only participants with data available at WOCF visit were analyzed.</description>
        <time_frame>Day 17</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Electrocardiogram (ECG) Findings</title>
          <description>Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) interval. Participants with abnormal ECG findings at worst-case observation Carried Forward for triplicate measurements (WOCF) post-Baseline visit are presented. Only participants with data available at WOCF visit were analyzed.</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
        <description>Vital sign measurements including SBP and DBP were taken in a supine position after at least 5 minutes of rest. Change from Baseline in SBP and DBP at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
        <time_frame>Baseline, Day 17 and Day 24</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
          <description>Vital sign measurements including SBP and DBP were taken in a supine position after at least 5 minutes of rest. Change from Baseline in SBP and DBP at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
          <units>Millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP; Day 17; n= 1, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-10.4" spread="10.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP; follow-up; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-10.0" spread="12.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP; Day 17; n= 1, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-3.4" spread="13.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP; follow-up; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="0.1" spread="12.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pulse Rate</title>
        <description>Vital sign measurements including pulse rate were taken in a supine position after at least 5 minutes of rest. Change from Baseline in pulse rate at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
        <time_frame>Baseline, Day 17 and Day 24</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pulse Rate</title>
          <description>Vital sign measurements including pulse rate were taken in a supine position after at least 5 minutes of rest. Change from Baseline in pulse rate at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 17; n= 1, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-5.6" spread="9.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.0" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-7.0" spread="11.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Temperature</title>
        <description>Vital sign measurements including body temperature were taken in a supine position after at least 5 minutes of rest. Change from Baseline in body temperature at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
        <time_frame>Baseline, Day 17 and Day 24</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Temperature</title>
          <description>Vital sign measurements including body temperature were taken in a supine position after at least 5 minutes of rest. Change from Baseline in body temperature at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
          <units>Degree celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 17; n= 1, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.20" spread="0.648"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.90" spread="NA">Standard deviation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="-0.30" spread="0.548"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Physical Examination Findings</title>
        <description>A complete physical examination was planned to include assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. This analysis was planned but not performed. Any significant finding was captured as an AE.</description>
        <time_frame>Up to Day 17</time_frame>
        <population>All Subjects Population</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Physical Examination Findings</title>
          <description>A complete physical examination was planned to include assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. This analysis was planned but not performed. Any significant finding was captured as an AE.</description>
          <population>All Subjects Population</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peritoneal Dialysis Clearance of GSK1278863 and Metabolites</title>
        <description>Peritoneal dialysate samples for PK analysis of GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) were collected. Peritoneal dialysis clearance of GSK1278863 and metabolites was calculated from Day 14 dialysate excretion data as total amount of analyte excreted over 24 hours divided by plasma AUC (0-tau). Geometric mean and geometric coefficient of variation are presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
        <time_frame>Day 14</time_frame>
        <population>PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Peritoneal Dialysis Clearance of GSK1278863 and Metabolites</title>
          <description>Peritoneal dialysate samples for PK analysis of GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) were collected. Peritoneal dialysis clearance of GSK1278863 and metabolites was calculated from Day 14 dialysate excretion data as total amount of analyte excreted over 24 hours divided by plasma AUC (0-tau). Geometric mean and geometric coefficient of variation are presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
          <population>PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
          <units>Milliliter per hour</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="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK1278863; n= 1, 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.07" spread="NA">Geometric mean and geometric coefficient of variation could not be calculated for APD cohort due to insufficient data</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154.68" spread="NA">Geometric mean and geometric coefficient of variation could not be calculated for APD cohort due to insufficient data</measurement>
                    <measurement group_id="O2" value="31.68" spread="165.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818; n= 1, 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124.40" spread="NA">Geometric mean and geometric coefficient of variation could not be calculated for APD cohort due to insufficient data</measurement>
                    <measurement group_id="O2" value="13.08" spread="195.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167.89" spread="NA">Geometric mean and geometric coefficient of variation could not be calculated for APD cohort due to insufficient data</measurement>
                    <measurement group_id="O2" value="40.05" spread="169.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151.29" spread="NA">Geometric mean and geometric coefficient of variation could not be calculated for APD cohort due to insufficient data</measurement>
                    <measurement group_id="O2" value="28.39" spread="177.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531403; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155.75" spread="NA">Geometric mean and geometric coefficient of variation could not be calculated for APD cohort due to insufficient data</measurement>
                    <measurement group_id="O2" value="36.18" spread="183.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="201.80" spread="NA">Geometric mean and geometric coefficient of variation could not be calculated for APD cohort due to insufficient data</measurement>
                    <measurement group_id="O2" value="48.89" spread="199.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Phase Half-life (t 1/2) of GSK1278863 and Metabolites</title>
        <description>Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403, GSK2531401). Geometric mean and geometric coefficient of variation have been presented for all metabolites. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants, which is indicated by NA. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
        <time_frame>Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14</time_frame>
        <population>PK Population. Only participants available at specified time points were analyzed. Due to lack of quantifiable plasma concentrations in terminal elimination phase (Day 1) of 4 metabolites GSK2391220,GSK2506102,GSK2531403,GSK2531401, terminal slope(lambda z) could not be determined,thus t1/2 could not be calculated as it depends on lambda z value.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Phase Half-life (t 1/2) of GSK1278863 and Metabolites</title>
          <description>Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403, GSK2531401). Geometric mean and geometric coefficient of variation have been presented for all metabolites. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants, which is indicated by NA. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
          <population>PK Population. Only participants available at specified time points were analyzed. Due to lack of quantifiable plasma concentrations in terminal elimination phase (Day 1) of 4 metabolites GSK2391220,GSK2506102,GSK2531403,GSK2531401, terminal slope(lambda z) could not be determined,thus t1/2 could not be calculated as it depends on lambda z value.</population>
          <units>Hours</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="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK1278863; Day 1; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6256" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="1.9870" spread="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK1278863; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8088" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="2.5312" spread="35.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2225" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="10.2882" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818; Day 1; n=1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6560" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="3.3612" spread="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9958" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="3.8955" spread="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102; Day 14; n= 1,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2000" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="17.7692" spread="65.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398; Day 1; n=1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7900" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="7.0659" spread="35.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8275" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="7.3088" spread="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531403; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0606" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="14.5877" spread="43.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7794" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="26.9981" spread="54.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Occurrence of Cmax (Tmax) of GSK1278863 and Metabolites</title>
        <description>Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Median and full range have been presented for all metabolites. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
        <time_frame>Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14</time_frame>
        <population>PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Occurrence of Cmax (Tmax) of GSK1278863 and Metabolites</title>
          <description>Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Median and full range have been presented for all metabolites. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
          <population>PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
          <units>Hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK1278863; Day 1; n=1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" lower_limit="0.5" upper_limit="0.5"/>
                    <measurement group_id="O2" value="1.00" lower_limit="1.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK1278863; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="2.0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="2.00" lower_limit="1.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220; Day 1; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" lower_limit="3.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="4.00" lower_limit="3.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="4.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="5.00" lower_limit="4.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818; Day 1; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" lower_limit="3.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="4.00" lower_limit="2.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" lower_limit="3.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="4.00" lower_limit="3.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102; Day 1; n=1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="4.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="8.00" lower_limit="3.0" upper_limit="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="4.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="5.00" lower_limit="4.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398; Day 1; n= 1,7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="4.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="4.00" lower_limit="3.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="4.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="5.00" lower_limit="4.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531403; Day 1; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.00" lower_limit="6.0" upper_limit="6.0"/>
                    <measurement group_id="O2" value="6.00" lower_limit="2.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531403; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="4.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="6.00" lower_limit="4.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401; Day 1; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.00" lower_limit="8.0" upper_limit="8.0"/>
                    <measurement group_id="O2" value="8.00" lower_limit="3.0" upper_limit="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401; Day 14; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.00" lower_limit="8.0" upper_limit="8.0"/>
                    <measurement group_id="O2" value="9.00" lower_limit="6.0" upper_limit="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accumulation Ratio of GSK1278863 and Metabolites</title>
        <description>The observed accumulation ratio was determined to estimate the extent of accumulation for GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) after repeat dosing. Accumulation ratio was calculated by using AUC (0-tau) values at Day 1 and Day 14. Analysis was performed using mixed effect model fitted with day (single and repeat dose) as fixed effect and participant as random effect. Mean ratio and 90% confidence intervals have been presented.</description>
        <time_frame>Day 1 and Day 14</time_frame>
        <population>PK Population. CAPD and APD arms were combined to present data for All participants analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Participants received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Accumulation Ratio of GSK1278863 and Metabolites</title>
          <description>The observed accumulation ratio was determined to estimate the extent of accumulation for GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) after repeat dosing. Accumulation ratio was calculated by using AUC (0-tau) values at Day 1 and Day 14. Analysis was performed using mixed effect model fitted with day (single and repeat dose) as fixed effect and participant as random effect. Mean ratio and 90% confidence intervals have been presented.</description>
          <population>PK Population. CAPD and APD arms were combined to present data for All participants analyzed.</population>
          <units>Ratio of AUC</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK1278863</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.896" lower_limit="0.645" upper_limit="1.244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.176" lower_limit="1.043" upper_limit="1.326"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.019" lower_limit="0.944" upper_limit="1.100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.581" lower_limit="1.200" upper_limit="2.081"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.116" lower_limit="1.015" upper_limit="1.228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531403</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.415" lower_limit="1.131" upper_limit="1.771"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.948" lower_limit="1.301" upper_limit="2.918"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Invariance Ratio of GSK1278863 and Metabolites</title>
        <description>Time invariance ratio for GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) was calculated by analyzing AUC (0-inf) at Day 1 and AUC (0-tau) at Day 14. Analysis was performed using mixed effect model fitted with day (single and repeat dose) as fixed effect and participant as random effect. Mean ratio and 90% confidence intervals have been presented. NA indicates data is not available. Data could not be calculated due to insufficient data.</description>
        <time_frame>Day 1 and Day 14</time_frame>
        <population>PK Population. CAPD and APD arms were combined to present data for all participants analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Participants received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time Invariance Ratio of GSK1278863 and Metabolites</title>
          <description>Time invariance ratio for GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) was calculated by analyzing AUC (0-inf) at Day 1 and AUC (0-tau) at Day 14. Analysis was performed using mixed effect model fitted with day (single and repeat dose) as fixed effect and participant as random effect. Mean ratio and 90% confidence intervals have been presented. NA indicates data is not available. Data could not be calculated due to insufficient data.</description>
          <population>PK Population. CAPD and APD arms were combined to present data for all participants analyzed.</population>
          <units>Ratio of AUC</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK1278863; 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="0.896" lower_limit="0.645" upper_limit="1.244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2391220; n= 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>GSK2487818; 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="1.007" lower_limit="0.932" upper_limit="1.087"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102; n= 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>GSK2531398; 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="0.986" lower_limit="0.941" upper_limit="1.033"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531403; n= 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>GSK2531401; n= 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentration of Erythropoietin</title>
        <description>Serial blood samples were collected from participants at indicated time points to analyze plasma concentration of erythropoietin after repeat-dose administration of GSK1278863. Geometric mean and geometric coefficient of variation have been presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
        <time_frame>Pre-dose and 4, 8 ,12, 24 hours post-dose on Day 1 and Day 14; Pre-dose on Day 3, 7, 11</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Erythropoietin</title>
          <description>Serial blood samples were collected from participants at indicated time points to analyze plasma concentration of erythropoietin after repeat-dose administration of GSK1278863. Geometric mean and geometric coefficient of variation have been presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
          <units>IU/L</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="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1; pre-dose; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.860" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants</measurement>
                    <measurement group_id="O2" value="11.363" spread="124.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1; 4 hours; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.590" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants</measurement>
                    <measurement group_id="O2" value="14.494" spread="127.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1; 8 hours; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.540" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants</measurement>
                    <measurement group_id="O2" value="36.257" spread="96.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1; 12 hours; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.210" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants</measurement>
                    <measurement group_id="O2" value="32.629" spread="112.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1; 24 hours; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.570" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants</measurement>
                    <measurement group_id="O2" value="13.005" spread="127.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3; pre-dose; n= 1, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.030" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants</measurement>
                    <measurement group_id="O2" value="15.452" spread="152.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7; pre-dose; n= 1, 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.070" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants</measurement>
                    <measurement group_id="O2" value="8.023" spread="66.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11; pre-dose; n= 1, 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.690" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants</measurement>
                    <measurement group_id="O2" value="9.466" spread="69.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14; pre-dose; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.490" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants</measurement>
                    <measurement group_id="O2" value="6.036" spread="71.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14; 4 hours; n= 1, 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.660" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants</measurement>
                    <measurement group_id="O2" value="7.674" spread="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14; 8 hours; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.220" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants</measurement>
                    <measurement group_id="O2" value="19.313" spread="81.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14; 12 hours; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.050" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants</measurement>
                    <measurement group_id="O2" value="25.745" spread="74.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14; 24 hours; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.590" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants</measurement>
                    <measurement group_id="O2" value="6.735" spread="88.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentration of Hepcidin</title>
        <description>Serial blood samples were collected from participants at indicated time points to analyze plasma concentration of hepcidin after repeat-dose administration of GSK1278863. Geometric mean and geometric coefficient of variation have been presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
        <time_frame>Pre-dose and 4, 8 ,12, 24 hours post-dose on Day 1 and Day 14; Pre-dose on Day 3, 7, 11</time_frame>
        <population>All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Undergoing CAPD</title>
            <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
          <group group_id="O2">
            <title>Participants Undergoing APD</title>
            <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Hepcidin</title>
          <description>Serial blood samples were collected from participants at indicated time points to analyze plasma concentration of hepcidin after repeat-dose administration of GSK1278863. Geometric mean and geometric coefficient of variation have been presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</description>
          <population>All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).</population>
          <units>Micrograms per liter</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="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1; pre-dose; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1143.00" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="863.21" spread="100.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1; 4 hours; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1286.00" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="922.86" spread="108.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1; 8 hours; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1427.10" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="760.14" spread="80.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1; 12 hours; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1318.00" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="812.62" spread="86.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1; 24 hours; n= 1, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="867.20" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="802.06" spread="93.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3; pre-dose; n= 1, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1021.70" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="819.17" spread="90.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7; pre-dose; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="825.30" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="839.42" spread="81.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11; pre-dose; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="852.90" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="800.77" spread="91.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14; pre-dose; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="734.30" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="768.33" spread="86.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14; 4 hours; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="847.90" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="782.59" spread="81.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14; 8 hours; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="809.90" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="738.96" spread="79.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14; 12 hours; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="705.70" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="757.72" spread="87.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14; 24 hours; n= 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="801.30" spread="NA">Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.</measurement>
                    <measurement group_id="O2" value="733.66" spread="81.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>SAEs and non-SAEs are presented from the start of study treatment up to Day 24</time_frame>
      <desc>SAEs and non-serious AEs are reported for members of the All Subjects Population</desc>
      <group_list>
        <group group_id="E1">
          <title>Participants Undergoing CAPD</title>
          <description>Participants on CAPD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night CAPD treatment or morning last fill of peritoneal dialysis fluid.</description>
        </group>
        <group group_id="E2">
          <title>Participants Undergoing APD</title>
          <description>Participants on APD received 1 tablet (5 mg) of GSK1278863 by oral route once daily with half glass of water for 14 days. On Day 1 and Day14, the dose was administered within 30 minutes after completion of night APD treatment or morning last fill of peritoneal dialysis fluid; on any other study days, the dose was administered within 2 hours after completion of night APD treatment or morning last fill of peritoneal dialysis fluid.</description>
        </group>
      </group_list>
      <serious_events>
        <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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </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="1"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </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/NCT02243306
org study id: 200942
secondary id: 2014-001197-34
nct id: NCT02243306
lead sponsor: 
has dmc: No
GSK1278863 is an orally-active, novel small molecule agent which inhibits hypoxia-inducible
      factor (HIF) prolyl -4- hydroxylases (PHDs) and is in development for the treatment of
      anaemia associated with chronic kidney disease (CKD). As the kidney represents a major site
      of elimination for many drugs and their metabolites, and GSK1278863 will be administered to
      subjects with various stages of renal disease, it is important to characterize the
      pharmacokinetics in this target patient population. The purpose of this study is to
      characterize the pharmacokinetics of GSK1278863 and its metabolites in subjects with end
      stage renal disease (ESRD) undergoing peritoneal dialysis. This will be a repeat-dose,
      open-label, parallel-group study. Approximately 30 subjects with ESRD will be enrolled in two
      cohorts (15 subjects in each cohort) to ensure that 6 subjects on continuous ambulatory
      peritoneal dialysis (CAPD) (cohort 1) and 6 subjects on automated peritoneal dialysis APD
      (cohort 2) complete dosing and critical assessments. GSK1278863 will be administered once
      daily for 14 days. Primary pharmacokinetic assessments will be made on Days 1 and 14.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites
time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14
description: Serial blood samples were collected from participants at indicated time points for Pharmacokinetic (PK) analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. PK Population comprised of participants in the 'All Subjects' Population for whom a PK sample was obtained and analyzed.
measure: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-inf]) of GSK1278863 and Its Metabolites
time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1
description: Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2487818 and GSK2531398). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.
measure: Maximum Observed Concentration (Cmax) of GSK1278863 and Its Metabolites
time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14
description: Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
measure: Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
time frame: Up to Day 24
description: An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations, and is associated with liver injury and impaired liver function. Analysis was performed on All Subjects Population which comprised of all enrolled participants who received at least one dose of study treatment.
measure: Change From Baseline in Glucose, Calcium, Chloride, Carbon-dioxide (CO2), Potassium, Sodium and Urea Levels
time frame: Baseline and Day 17
description: Blood samples were collected from participants to evaluate clinical chemistry parameters including glucose, calcium, chloride, CO2, potassium, sodium and urea. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.
measure: Change From Baseline in Albumin and Protein Levels
time frame: Baseline and Day 17
description: Blood samples were collected from participants to evaluate clinical chemistry parameters including albumin and protein. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.
measure: Change From Baseline in Direct Bilirubin, Bilirubin, Creatinine and Urate Levels
time frame: Baseline and Day 17
description: Blood samples were collected from participants to evaluate clinical chemistry parameters including direct bilirubin, bilirubin, creatinine and urate. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.
measure: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Aminotransferase (GGT) Levels
time frame: Baseline and Day 17
description: Blood samples were collected from participants to evaluate clinical chemistry parameters including ALP, AST and GGT. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.
measure: Change From Baseline in Alanine Aminotransferase (ALT) and Creatinine Kinase Levels
time frame: Baseline and Day 3, 7, 11, 14, 17
description: Blood samples were collected from participants to evaluate clinical chemistry parameters including ALT and creatinine kinase. Change from Baseline in clinical chemistry parameters at Day 3, Day 7, Day 11, Day 14 and Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
measure: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Levels
time frame: Baseline and Day 17
description: Blood samples were collected from participants to evaluate clinical hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. NA indicates data is not available. Mean and standard deviation are presented. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.
measure: Change From Baseline in Erythrocyte and Reticulocyte Levels
time frame: Baseline and Day 17
description: Blood samples were collected from participants to evaluate clinical hematology parameters including erythrocyte and reticulocyte. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. NA indicates data is not available. Mean and standard deviation are presented. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.
measure: Change From Baseline in Hematocrit Levels
time frame: Baseline and Day 17
description: Blood samples were collected from participants to evaluate clinical hematology parameters including hematocrit. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.
measure: Change From Baseline in Hemoglobin Levels
time frame: Baseline and Day 3, 7, 11, 17
description: Blood samples were collected from participants to evaluate clinical hematology parameters including hemoglobin. Change from Baseline in clinical hematology parameters at Day 3, Day 7, Day 11 and Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
measure: Change From Baseline in Mean Corpuscular Hemoglobin Concentration (MCHC)
time frame: Baseline and Day 17
description: Blood samples were collected from participants to evaluate clinical hematology parameters including MCHC. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.
measure: Change From Baseline in Mean Corpuscular Volume (MCV)
time frame: Baseline and Day 17
description: Blood samples were collected from participants to evaluate clinical hematology parameters including MCV. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.
measure: Change From Baseline in Mean Corpuscular Hemoglobin (MCH) Levels
time frame: Baseline and Day 17
description: Blood samples were collected from participants to evaluate clinical hematology parameters including MCH. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
time frame: Day 17
description: Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) interval. Participants with abnormal ECG findings at worst-case observation Carried Forward for triplicate measurements (WOCF) post-Baseline visit are presented. Only participants with data available at WOCF visit were analyzed.
measure: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
time frame: Baseline, Day 17 and Day 24
description: Vital sign measurements including SBP and DBP were taken in a supine position after at least 5 minutes of rest. Change from Baseline in SBP and DBP at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
measure: Change From Baseline in Pulse Rate
time frame: Baseline, Day 17 and Day 24
description: Vital sign measurements including pulse rate were taken in a supine position after at least 5 minutes of rest. Change from Baseline in pulse rate at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
measure: Change From Baseline in Body Temperature
time frame: Baseline, Day 17 and Day 24
description: Vital sign measurements including body temperature were taken in a supine position after at least 5 minutes of rest. Change from Baseline in body temperature at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
measure: Number of Participants With Abnormal Physical Examination Findings
time frame: Up to Day 17
description: A complete physical examination was planned to include assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. This analysis was planned but not performed. Any significant finding was captured as an AE.
measure: Peritoneal Dialysis Clearance of GSK1278863 and Metabolites
time frame: Day 14
description: Peritoneal dialysate samples for PK analysis of GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) were collected. Peritoneal dialysis clearance of GSK1278863 and metabolites was calculated from Day 14 dialysate excretion data as total amount of analyte excreted over 24 hours divided by plasma AUC (0-tau). Geometric mean and geometric coefficient of variation are presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
measure: Terminal Phase Half-life (t 1/2) of GSK1278863 and Metabolites
time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14
description: Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403, GSK2531401). Geometric mean and geometric coefficient of variation have been presented for all metabolites. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants, which is indicated by NA. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
measure: Time of Occurrence of Cmax (Tmax) of GSK1278863 and Metabolites
time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14
description: Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Median and full range have been presented for all metabolites. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
measure: Accumulation Ratio of GSK1278863 and Metabolites
time frame: Day 1 and Day 14
description: The observed accumulation ratio was determined to estimate the extent of accumulation for GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) after repeat dosing. Accumulation ratio was calculated by using AUC (0-tau) values at Day 1 and Day 14. Analysis was performed using mixed effect model fitted with day (single and repeat dose) as fixed effect and participant as random effect. Mean ratio and 90% confidence intervals have been presented.
measure: Time Invariance Ratio of GSK1278863 and Metabolites
time frame: Day 1 and Day 14
description: Time invariance ratio for GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) was calculated by analyzing AUC (0-inf) at Day 1 and AUC (0-tau) at Day 14. Analysis was performed using mixed effect model fitted with day (single and repeat dose) as fixed effect and participant as random effect. Mean ratio and 90% confidence intervals have been presented. NA indicates data is not available. Data could not be calculated due to insufficient data.
measure: Plasma Concentration of Erythropoietin
time frame: Pre-dose and 4, 8 ,12, 24 hours post-dose on Day 1 and Day 14; Pre-dose on Day 3, 7, 11
description: Serial blood samples were collected from participants at indicated time points to analyze plasma concentration of erythropoietin after repeat-dose administration of GSK1278863. Geometric mean and geometric coefficient of variation have been presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
measure: Plasma Concentration of Hepcidin
time frame: Pre-dose and 4, 8 ,12, 24 hours post-dose on Day 1 and Day 14; Pre-dose on Day 3, 7, 11
description: Serial blood samples were collected from participants at indicated time points to analyze plasma concentration of hepcidin after repeat-dose administration of GSK1278863. Geometric mean and geometric coefficient of variation have been presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
arm group label: Cohort 1
arm group type: Experimental
description: Subjects on continuous ambulatory peritoneal dialysis (CAPD) will receive 5 mg of GSK1278863 orally, once daily for 14 days.
arm group label: Cohort 2
arm group type: Experimental
description: Subjects on automated peritoneal dialysis (APD) will receive 5 mg of GSK1278863 orally, once daily for 14 days
intervention type: Drug
intervention name: GSK1278863
description: Round, biconvex, white film coated tablet containing 5 mg GSK1278863.
arm group label: Cohort 1
arm group label: Cohort 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
country: United States
country: United Kingdom
citation: Caltabiano S, Cizman B, Burns O, Mahar KM, Johnson BM, Ramanjineyulu B, Serbest G, Cobitz AR. Effect of renal function and dialysis modality on daprodustat and predominant metabolite exposure. Clin Kidney J. 2019 Feb 18;12(5):693-701. doi: 10.1093/ckj/sfz013. eCollection 2019 Oct.
PMID: 31583094
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 