<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/NCT02260193</url>
  </required_header>
  <id_info>
    <org_study_id>AKB-6548-CI-0011</org_study_id>
    <nct_id>NCT02260193</nct_id>
  </id_info>
  <brief_title>16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis</brief_title>
  <official_title>Phase 2 Open-Label Study to Assess the Efficacy, Safety, and Tolerability of AKB-6548 in Subjects With Anemia Secondary to End Stage Renal Disease (ESRD), Undergoing Chronic Hemodialysis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Akebia Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Akebia Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and&#xD;
      tolerability of orally administered AKB-6548 in participants with end stage renal disease&#xD;
      undergoing chronic hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2014</start_date>
  <completion_date type="Actual">July 22, 2015</completion_date>
  <primary_completion_date type="Actual">July 22, 2015</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average</measure>
    <time_frame>Pre-dose (Screening, Second Screening, and Baseline), Week 7, and Week 8</time_frame>
    <description>Change from pre-dose average was calculated by the mid-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Pre-dose Average in Hgb Level to The End-of-study Average</measure>
    <time_frame>Pre-dose, Week 15, and Week 16</time_frame>
    <description>Change from pre-dose average was calculated by the end-of-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Mid-study Average in Hgb Level to The End-of-study Average</measure>
    <time_frame>Week 7, Week 8, Week 15, and Week 16</time_frame>
    <description>Change from mid-study average was calculated by the end-of-study average minus the mid-study average. The mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hgb</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
    <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hgb was defined as the average of the three samples obtained prior to dosing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hematocrit</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
    <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hematocrit was defined as the last observation before the first dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Red Blood Cell (RBC) Count</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
    <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline RBC Count was defined as the average of the three samples obtained prior to dosing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Absolute Reticulocyte Count</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
    <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline absolute reticulocyte count was defined as the last observation before the first dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Percent Reticulocyte Count</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
    <description>Change from Baseline was calculated as (visit value minus the Baseline value)/ Baseline value x 100. Baseline percent reticulocyte count was defined as the last observation before the first dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Reticulocyte Hgb Content</measure>
    <time_frame>Baseline, Week 2, Week 4, Week 8, and Week 16</time_frame>
    <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline reticulocyte Hgb content was defined as the average of the three samples obtained prior to dosing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ferritin</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
    <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline ferritin was defined as the last observation before the first dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hepcidin</measure>
    <time_frame>Baseline, Week 8, and Week 16</time_frame>
    <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline hepcidin was defined as the last observation before the first dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Iron-Binding Capacity (TIBC)</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
    <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline TIBC was defined as the last observation before the first dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Transferrin Saturation (TSAT)</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
    <description>Change from Baseline was calculated as (visit value minus the Baseline value)/ Baseline value x 100. Baseline TSAT was defined as the last observation before the first dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Iron</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
    <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline iron was defined as the last observation before the first dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Erythropoiesis-stimulating Agent (ESA) Rescue Therapy</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>ESA rescue therapy was administered in participants with Hgb ≤12.5 g/dL, and was stopped when Hgb reached ≥13.0 g/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Blood Transfusion Rescue Therapy</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>Blood transfusion rescue therapy was administered in participants with Hgb ≤12.5 g/dL, and was stopped when Hgb reached ≥13.0 g/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Plasma Concentrations of Vadadustat</measure>
    <time_frame>Pre-dialysis and post-dialysis on Week 2 and Week 16</time_frame>
    <description>Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Plasma Concentrations of Vadadustat-O-Glucuronide Metabolite</measure>
    <time_frame>Pre-dialysis and post-dialysis on Week 2 and Week 16</time_frame>
    <description>Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Plasma Concentrations of Vadadustat-Acyl-Glucuronide Metabolite</measure>
    <time_frame>Pre-dialysis and post-dialysis on Week 2 and Week 16</time_frame>
    <description>Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to Week 20</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. A TEAE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. A SAE included AEs that met one or more of the following criteria/outcomes: death, lifethreatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, and congenital anomaly/birth defect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Changes From Baseline in Vital Signs</measure>
    <time_frame>Up to Week 20</time_frame>
    <description>Parameters assessed for vital signs included sitting blood pressure, pulse, respiratory rate, and body temperature. The investigator was responsible for reviewing laboratory results for clinically significant changes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values</measure>
    <time_frame>Up to Week 20</time_frame>
    <description>Parameters assessed for laboratory values included hematology, serum chemistry, urinalysis, iron indices, C-reactive protein, lipid profile, biomarkers, and pregnancy tests. The investigator was responsible for reviewing laboratory results for clinically significant changes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings</measure>
    <time_frame>Up to Week 20</time_frame>
    <description>A standard 12-lead ECG was performed following dosing in a supine position for approximately 5 minutes. ECGs were taken prior to vital sign assessments, circulatory access cannulation, and blood draws when possible. Clinical significance was determined by the investigator.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mean Intravenous Iron Replacement Therapy</measure>
    <time_frame>Baseline, Week 8, and Week 16</time_frame>
    <description>Intravenous iron was administered throughout the study to maintain ferritin levels in the range of ≥100 ng/mL to ≤1200 ng/mL.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Anemia</condition>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>AKB-6548, starting dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>AKB-6548, starting dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>AKB-6548, starting dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AKB-6548</intervention_name>
    <description>Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.</description>
    <arm_group_label>AKB-6548, starting dose 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AKB-6548</intervention_name>
    <description>Starting dose 2. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.</description>
    <arm_group_label>AKB-6548, starting dose 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AKB-6548</intervention_name>
    <description>Starting dose 3. Oral dose administered three times weekly for 16 weeks. Dose adjustment based on hemoglobin levels as defined in the protocol.</description>
    <arm_group_label>AKB-6548, starting dose 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  18 to 79 years inclusive&#xD;
&#xD;
          -  Chronic Kidney Disease (CKD) Stage 5 on chronic hemodialysis for at least 3 months&#xD;
&#xD;
          -  Anemia secondary to CKD treated with erythropoiesis stimulating agent and intravenous&#xD;
             iron&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index &gt;44.0 kilograms per meter squared (kg/m^2)&#xD;
&#xD;
          -  Transfusion within 8 weeks prior to Screening&#xD;
&#xD;
          -  Alanine transaminase or total bilirubin &gt;1.25x ULN&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Class III or IV congestive heart failure&#xD;
&#xD;
          -  Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack&#xD;
             within 6 months prior to Screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chief Medical Officer</last_name>
    <role>Study Director</role>
    <affiliation>Akebia Therapeutics Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>El Granada</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Dimas</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Clarita</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Arvada</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Westminster</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Astoria</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Grand Prairie</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greenville</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mechanicsville</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://ir.akebia.com/static-files/0c2473ab-894a-44de-9ee9-22734dca47bf</url>
    <description>Vadadustat, a Novel, Oral Treatment for Anemia of CKD, Maintains Stable Hemoglobin Levels in Dialysis Patients Converting from Erythropoiesis-Stimulating Agents</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <results_first_submitted>April 22, 2022</results_first_submitted>
  <results_first_submitted_qc>June 7, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 1, 2022</results_first_posted>
  <disposition_first_submitted>October 23, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>October 23, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">November 17, 2015</disposition_first_posted>
  <last_update_submitted>June 7, 2022</last_update_submitted>
  <last_update_submitted_qc>June 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anemia</keyword>
  <keyword>end stage renal disease</keyword>
  <keyword>chronic kidney disease</keyword>
  <keyword>CKD</keyword>
  <keyword>dialysis</keyword>
  <keyword>chronic renal insufficiency</keyword>
  <keyword>renal impairment</keyword>
  <keyword>erythropoietin</keyword>
  <keyword>kidney</keyword>
  <keyword>oral anemia treatment</keyword>
  <keyword>hemoglobin</keyword>
  <keyword>hypoxia-inducible factor</keyword>
  <keyword>HIF</keyword>
  <keyword>hypoxia-inducible factor propyl-hydroxylase inhibitor</keyword>
  <keyword>HIF-PHI</keyword>
  <keyword>pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glycine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 128 participants were screened, of which 94 participants were enrolled and randomized into the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Vadadustat 300 mg Once Daily (QD)</title>
          <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
        </group>
        <group group_id="P2">
          <title>Vadadustat 450 mg QD</title>
          <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
        </group>
        <group group_id="P3">
          <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
          <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Kidney Transplantation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Vadadustat 300 mg Once Daily (QD)</title>
          <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
        </group>
        <group group_id="B2">
          <title>Vadadustat 450 mg QD</title>
          <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
        </group>
        <group group_id="B3">
          <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
          <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
        </group>
        <group group_id="B4">
          <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="30"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="31"/>
            <count group_id="B4" value="94"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.5" spread="12.44"/>
                    <measurement group_id="B2" value="59.4" spread="11.62"/>
                    <measurement group_id="B3" value="57.8" spread="8.26"/>
                    <measurement group_id="B4" value="57.6" spread="10.93"/>
                  </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="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average</title>
        <description>Change from pre-dose average was calculated by the mid-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits.</description>
        <time_frame>Pre-dose (Screening, Second Screening, and Baseline), Week 7, and Week 8</time_frame>
        <population>Modified Intent-to-treat (MITT) Population: All participants who were assigned to study medication, received at least 1 dose of study medication, and had a pre-dose average and at least one post-baseline Hgb measurement. The primary analysis was performed in the MITT population using observed Hgb data without imputation for missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average</title>
          <description>Change from pre-dose average was calculated by the mid-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits.</description>
          <population>Modified Intent-to-treat (MITT) Population: All participants who were assigned to study medication, received at least 1 dose of study medication, and had a pre-dose average and at least one post-baseline Hgb measurement. The primary analysis was performed in the MITT population using observed Hgb data without imputation for missing data.</population>
          <units>Grams per deciliter (g/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose Average</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.43" spread="0.645"/>
                    <measurement group_id="O2" value="10.55" spread="0.577"/>
                    <measurement group_id="O3" value="10.52" spread="0.534"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from pre-dose average to the mid-study average</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.897"/>
                    <measurement group_id="O2" value="-0.29" spread="0.970"/>
                    <measurement group_id="O3" value="-0.36" spread="1.134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>0.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.25</ci_lower_limit>
            <ci_upper_limit>0.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>0.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.19</ci_lower_limit>
            <ci_upper_limit>0.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.48</ci_lower_limit>
            <ci_upper_limit>0.61</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Pre-dose Average in Hgb Level to The End-of-study Average</title>
        <description>Change from pre-dose average was calculated by the end-of-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.</description>
        <time_frame>Pre-dose, Week 15, and Week 16</time_frame>
        <population>MITT Population. The primary analysis was performed in the MITT population using observed Hgb data without imputation for missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pre-dose Average in Hgb Level to The End-of-study Average</title>
          <description>Change from pre-dose average was calculated by the end-of-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.</description>
          <population>MITT Population. The primary analysis was performed in the MITT population using observed Hgb data without imputation for missing data.</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose Average</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.43" spread="0.645"/>
                    <measurement group_id="O2" value="10.55" spread="0.577"/>
                    <measurement group_id="O3" value="10.52" spread="0.534"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Pre-dose average to The End-of-study Average</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.902"/>
                    <measurement group_id="O2" value="-0.07" spread="0.973"/>
                    <measurement group_id="O3" value="-0.14" spread="1.123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.54</ci_lower_limit>
            <ci_upper_limit>0.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Least Squares Mean Differences</param_type>
            <param_value>0.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.49</ci_lower_limit>
            <ci_upper_limit>0.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Least squares mean difference</param_type>
            <param_value>0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.53</ci_lower_limit>
            <ci_upper_limit>0.66</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Mid-study Average in Hgb Level to The End-of-study Average</title>
        <description>Change from mid-study average was calculated by the end-of-study average minus the mid-study average. The mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.</description>
        <time_frame>Week 7, Week 8, Week 15, and Week 16</time_frame>
        <population>MITT Population. The primary analysis was performed in the MITT population using observed Hgb data without imputation for missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Mid-study Average in Hgb Level to The End-of-study Average</title>
          <description>Change from mid-study average was calculated by the end-of-study average minus the mid-study average. The mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.</description>
          <population>MITT Population. The primary analysis was performed in the MITT population using observed Hgb data without imputation for missing data.</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mid-study Average</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.41" spread="0.834"/>
                    <measurement group_id="O2" value="10.26" spread="1.167"/>
                    <measurement group_id="O3" value="10.19" spread="0.950"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Mid-study Average to The End-of-study Average</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="0.512"/>
                    <measurement group_id="O2" value="0.16" spread="0.809"/>
                    <measurement group_id="O3" value="-0.07" spread="0.611"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Least squares mean difference</param_type>
            <param_value>-0.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.71</ci_lower_limit>
            <ci_upper_limit>0.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Least squares mean difference</param_type>
            <param_value>-0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.50</ci_lower_limit>
            <ci_upper_limit>0.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Least squares mean difference</param_type>
            <param_value>0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.16</ci_lower_limit>
            <ci_upper_limit>0.62</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hgb</title>
        <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hgb was defined as the average of the three samples obtained prior to dosing.</description>
        <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
        <population>MITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hgb</title>
          <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hgb was defined as the average of the three samples obtained prior to dosing.</description>
          <population>MITT Population</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.50" spread="0.702"/>
                    <measurement group_id="O2" value="10.51" spread="0.755"/>
                    <measurement group_id="O3" value="10.50" spread="0.646"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.708"/>
                    <measurement group_id="O2" value="-0.21" spread="0.814"/>
                    <measurement group_id="O3" value="-0.35" spread="0.887"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="1.058"/>
                    <measurement group_id="O2" value="-0.39" spread="1.201"/>
                    <measurement group_id="O3" value="-0.37" spread="1.386"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.995"/>
                    <measurement group_id="O2" value="-0.11" spread="1.087"/>
                    <measurement group_id="O3" value="-0.06" spread="1.210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.946"/>
                    <measurement group_id="O2" value="-0.13" spread="1.076"/>
                    <measurement group_id="O3" value="-0.06" spread="1.146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hematocrit</title>
        <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hematocrit was defined as the last observation before the first dose of study medication.</description>
        <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
        <population>MITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hematocrit</title>
          <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hematocrit was defined as the last observation before the first dose of study medication.</description>
          <population>MITT Population</population>
          <units>Percentage 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="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.2" spread="2.58"/>
                    <measurement group_id="O2" value="31.6" spread="3.75"/>
                    <measurement group_id="O3" value="31.4" spread="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="2.82"/>
                    <measurement group_id="O2" value="-1.4" spread="3.36"/>
                    <measurement group_id="O3" value="-0.7" spread="3.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="3.87"/>
                    <measurement group_id="O2" value="-1.6" spread="4.73"/>
                    <measurement group_id="O3" value="-1.7" spread="4.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="3.35"/>
                    <measurement group_id="O2" value="-0.8" spread="4.07"/>
                    <measurement group_id="O3" value="-0.1" spread="4.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="3.26"/>
                    <measurement group_id="O2" value="-1.2" spread="4.19"/>
                    <measurement group_id="O3" value="-0.2" spread="3.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Red Blood Cell (RBC) Count</title>
        <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline RBC Count was defined as the average of the three samples obtained prior to dosing.</description>
        <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
        <population>MITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Red Blood Cell (RBC) Count</title>
          <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline RBC Count was defined as the average of the three samples obtained prior to dosing.</description>
          <population>MITT Population</population>
          <units>10^6 cells per microliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.34" spread="0.278"/>
                    <measurement group_id="O2" value="3.49" spread="0.446"/>
                    <measurement group_id="O3" value="3.49" spread="0.385"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.235"/>
                    <measurement group_id="O2" value="-0.11" spread="0.346"/>
                    <measurement group_id="O3" value="-0.16" spread="0.276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.357"/>
                    <measurement group_id="O2" value="-0.19" spread="0.482"/>
                    <measurement group_id="O3" value="-0.16" spread="0.432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.325"/>
                    <measurement group_id="O2" value="-0.14" spread="0.473"/>
                    <measurement group_id="O3" value="-0.10" spread="0.464"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="0.309"/>
                    <measurement group_id="O2" value="-0.17" spread="0.453"/>
                    <measurement group_id="O3" value="-0.08" spread="0.412"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Absolute Reticulocyte Count</title>
        <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline absolute reticulocyte count was defined as the last observation before the first dose of study medication.</description>
        <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
        <population>MITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Absolute Reticulocyte Count</title>
          <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline absolute reticulocyte count was defined as the last observation before the first dose of study medication.</description>
          <population>MITT Population</population>
          <units>10^6 cells per microliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0704" spread="0.02548"/>
                    <measurement group_id="O2" value="0.0661" spread="0.02300"/>
                    <measurement group_id="O3" value="0.0742" spread="0.02777"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0059" spread="0.02166"/>
                    <measurement group_id="O2" value="0.0023" spread="0.02597"/>
                    <measurement group_id="O3" value="-0.0001" spread="0.02813"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0054" spread="0.01794"/>
                    <measurement group_id="O2" value="0.0041" spread="0.02492"/>
                    <measurement group_id="O3" value="-0.0018" spread="0.02571"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0001" spread="0.01592"/>
                    <measurement group_id="O2" value="0.0133" spread="0.02734"/>
                    <measurement group_id="O3" value="0.0033" spread="0.02479"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0009" spread="0.02251"/>
                    <measurement group_id="O2" value="0.0048" spread="0.02409"/>
                    <measurement group_id="O3" value="0.0040" spread="0.02470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Percent Reticulocyte Count</title>
        <description>Change from Baseline was calculated as (visit value minus the Baseline value)/ Baseline value x 100. Baseline percent reticulocyte count was defined as the last observation before the first dose of study medication.</description>
        <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
        <population>MITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Percent Reticulocyte Count</title>
          <description>Change from Baseline was calculated as (visit value minus the Baseline value)/ Baseline value x 100. Baseline percent reticulocyte count was defined as the last observation before the first dose of study medication.</description>
          <population>MITT Population</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.14" spread="0.802"/>
                    <measurement group_id="O2" value="1.89" spread="0.572"/>
                    <measurement group_id="O3" value="2.19" spread="0.927"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.16" spread="0.578"/>
                    <measurement group_id="O2" value="0.14" spread="0.787"/>
                    <measurement group_id="O3" value="0.07" spread="0.884"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="0.539"/>
                    <measurement group_id="O2" value="0.24" spread="0.649"/>
                    <measurement group_id="O3" value="0.03" spread="0.710"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.488"/>
                    <measurement group_id="O2" value="0.48" spread="0.704"/>
                    <measurement group_id="O3" value="0.17" spread="0.835"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.586"/>
                    <measurement group_id="O2" value="0.23" spread="0.701"/>
                    <measurement group_id="O3" value="0.15" spread="0.817"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Reticulocyte Hgb Content</title>
        <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline reticulocyte Hgb content was defined as the average of the three samples obtained prior to dosing.</description>
        <time_frame>Baseline, Week 2, Week 4, Week 8, and Week 16</time_frame>
        <population>MITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Reticulocyte Hgb Content</title>
          <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline reticulocyte Hgb content was defined as the average of the three samples obtained prior to dosing.</description>
          <population>MITT Population</population>
          <units>μg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.39" spread="1.799"/>
                    <measurement group_id="O2" value="32.12" spread="1.675"/>
                    <measurement group_id="O3" value="30.99" spread="2.372"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="1.302"/>
                    <measurement group_id="O2" value="-0.03" spread="0.972"/>
                    <measurement group_id="O3" value="1.01" spread="1.621"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.859"/>
                    <measurement group_id="O2" value="-0.21" spread="1.023"/>
                    <measurement group_id="O3" value="1.02" spread="1.425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" spread="1.159"/>
                    <measurement group_id="O2" value="-0.27" spread="1.308"/>
                    <measurement group_id="O3" value="1.13" spread="1.301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15" spread="1.026"/>
                    <measurement group_id="O2" value="0.58" spread="1.284"/>
                    <measurement group_id="O3" value="-0.18" spread="1.494"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Ferritin</title>
        <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline ferritin was defined as the last observation before the first dose of study medication.</description>
        <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
        <population>MITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ferritin</title>
          <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline ferritin was defined as the last observation before the first dose of study medication.</description>
          <population>MITT Population</population>
          <units>Nanograms per milliliter (ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="762.88" spread="470.462"/>
                    <measurement group_id="O2" value="781.96" spread="465.148"/>
                    <measurement group_id="O3" value="807.75" spread="430.981"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-48.80" spread="205.733"/>
                    <measurement group_id="O2" value="-61.21" spread="217.068"/>
                    <measurement group_id="O3" value="-10.29" spread="254.574"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.85" spread="529.361"/>
                    <measurement group_id="O2" value="-99.11" spread="240.436"/>
                    <measurement group_id="O3" value="-48.71" spread="289.063"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.70" spread="316.387"/>
                    <measurement group_id="O2" value="-61.81" spread="302.719"/>
                    <measurement group_id="O3" value="0.92" spread="342.188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-56.67" spread="317.098"/>
                    <measurement group_id="O2" value="-115.36" spread="276.640"/>
                    <measurement group_id="O3" value="-39.03" spread="484.937"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hepcidin</title>
        <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline hepcidin was defined as the last observation before the first dose of study medication.</description>
        <time_frame>Baseline, Week 8, and Week 16</time_frame>
        <population>MITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hepcidin</title>
          <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline hepcidin was defined as the last observation before the first dose of study medication.</description>
          <population>MITT Population</population>
          <units>Nanograms per milliliter (ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102.59" spread="58.938"/>
                    <measurement group_id="O2" value="119.61" spread="54.766"/>
                    <measurement group_id="O3" value="105.35" spread="46.805"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.46" spread="49.002"/>
                    <measurement group_id="O2" value="-27.80" spread="56.752"/>
                    <measurement group_id="O3" value="-9.14" spread="46.498"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.11" spread="46.526"/>
                    <measurement group_id="O2" value="-21.66" spread="45.381"/>
                    <measurement group_id="O3" value="-4.87" spread="50.379"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Iron-Binding Capacity (TIBC)</title>
        <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline TIBC was defined as the last observation before the first dose of study medication.</description>
        <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
        <population>MITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Iron-Binding Capacity (TIBC)</title>
          <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline TIBC was defined as the last observation before the first dose of study medication.</description>
          <population>MITT Population</population>
          <units>Micrograms per deciliter (μg/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="204.5" spread="39.72"/>
                    <measurement group_id="O2" value="196.7" spread="29.42"/>
                    <measurement group_id="O3" value="188.8" spread="32.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.7" spread="21.95"/>
                    <measurement group_id="O2" value="22.0" spread="32.18"/>
                    <measurement group_id="O3" value="18.7" spread="22.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.4" spread="28.13"/>
                    <measurement group_id="O2" value="30.3" spread="28.30"/>
                    <measurement group_id="O3" value="22.0" spread="25.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.6" spread="30.05"/>
                    <measurement group_id="O2" value="34.8" spread="28.69"/>
                    <measurement group_id="O3" value="23.9" spread="19.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7" spread="35.27"/>
                    <measurement group_id="O2" value="24.9" spread="29.10"/>
                    <measurement group_id="O3" value="25.7" spread="21.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Transferrin Saturation (TSAT)</title>
        <description>Change from Baseline was calculated as (visit value minus the Baseline value)/ Baseline value x 100. Baseline TSAT was defined as the last observation before the first dose of study medication.</description>
        <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
        <population>MITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Transferrin Saturation (TSAT)</title>
          <description>Change from Baseline was calculated as (visit value minus the Baseline value)/ Baseline value x 100. Baseline TSAT was defined as the last observation before the first dose of study medication.</description>
          <population>MITT Population</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.6" spread="11.63"/>
                    <measurement group_id="O2" value="33.7" spread="11.14"/>
                    <measurement group_id="O3" value="37.5" spread="13.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="15.49"/>
                    <measurement group_id="O2" value="2.1" spread="16.97"/>
                    <measurement group_id="O3" value="3.6" spread="15.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="15.92"/>
                    <measurement group_id="O2" value="1.2" spread="17.31"/>
                    <measurement group_id="O3" value="3.3" spread="14.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" spread="19.71"/>
                    <measurement group_id="O2" value="1.3" spread="17.18"/>
                    <measurement group_id="O3" value="3.7" spread="14.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="14.86"/>
                    <measurement group_id="O2" value="1.7" spread="17.44"/>
                    <measurement group_id="O3" value="2.5" spread="13.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Iron</title>
        <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline iron was defined as the last observation before the first dose of study medication.</description>
        <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
        <population>MITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Iron</title>
          <description>Change from Baseline was calculated as the visit value minus the Baseline value. Baseline iron was defined as the last observation before the first dose of study medication.</description>
          <population>MITT Population</population>
          <units>μg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.6" spread="26.25"/>
                    <measurement group_id="O2" value="66.6" spread="23.74"/>
                    <measurement group_id="O3" value="75.4" spread="32.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" spread="32.47"/>
                    <measurement group_id="O2" value="18.5" spread="40.91"/>
                    <measurement group_id="O3" value="13.3" spread="30.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3" spread="33.38"/>
                    <measurement group_id="O2" value="11.6" spread="39.10"/>
                    <measurement group_id="O3" value="15.0" spread="30.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.7" spread="46.73"/>
                    <measurement group_id="O2" value="10.8" spread="31.44"/>
                    <measurement group_id="O3" value="15.5" spread="28.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline to Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" spread="34.43"/>
                    <measurement group_id="O2" value="10.3" spread="37.16"/>
                    <measurement group_id="O3" value="14.0" spread="28.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Erythropoiesis-stimulating Agent (ESA) Rescue Therapy</title>
        <description>ESA rescue therapy was administered in participants with Hgb ≤12.5 g/dL, and was stopped when Hgb reached ≥13.0 g/dL.</description>
        <time_frame>Up to Week 16</time_frame>
        <population>Intent-to-treat (ITT) Population: All participants who were assigned to study medication and received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Erythropoiesis-stimulating Agent (ESA) Rescue Therapy</title>
          <description>ESA rescue therapy was administered in participants with Hgb ≤12.5 g/dL, and was stopped when Hgb reached ≥13.0 g/dL.</description>
          <population>Intent-to-treat (ITT) Population: All participants who were assigned to study medication and received at least 1 dose of study medication.</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="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Blood Transfusion Rescue Therapy</title>
        <description>Blood transfusion rescue therapy was administered in participants with Hgb ≤12.5 g/dL, and was stopped when Hgb reached ≥13.0 g/dL.</description>
        <time_frame>Up to Week 16</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Blood Transfusion Rescue Therapy</title>
          <description>Blood transfusion rescue therapy was administered in participants with Hgb ≤12.5 g/dL, and was stopped when Hgb reached ≥13.0 g/dL.</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Plasma Concentrations of Vadadustat</title>
        <description>Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session.</description>
        <time_frame>Pre-dialysis and post-dialysis on Week 2 and Week 16</time_frame>
        <population>ITT Population. Participants with available data were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Plasma Concentrations of Vadadustat</title>
          <description>Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session.</description>
          <population>ITT Population. Participants with available data were included in the analysis.</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2 pre-dialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.89" spread="13.876"/>
                    <measurement group_id="O2" value="17.27" spread="12.741"/>
                    <measurement group_id="O3" value="5.329" spread="5.0281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 post-dialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.72" spread="13.728"/>
                    <measurement group_id="O2" value="18.69" spread="15.601"/>
                    <measurement group_id="O3" value="5.287" spread="5.2117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 pre-dialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.41" spread="8.7716"/>
                    <measurement group_id="O2" value="15.98" spread="12.059"/>
                    <measurement group_id="O3" value="4.813" spread="3.6094"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 post-dialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.85" spread="11.921"/>
                    <measurement group_id="O2" value="17.38" spread="12.516"/>
                    <measurement group_id="O3" value="3.998" spread="2.9709"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Plasma Concentrations of Vadadustat-O-Glucuronide Metabolite</title>
        <description>Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session.</description>
        <time_frame>Pre-dialysis and post-dialysis on Week 2 and Week 16</time_frame>
        <population>ITT Population. Participants with available data were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Plasma Concentrations of Vadadustat-O-Glucuronide Metabolite</title>
          <description>Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session.</description>
          <population>ITT Population. Participants with available data were included in the analysis.</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2 pre-dialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.66" spread="13.508"/>
                    <measurement group_id="O2" value="26.36" spread="21.111"/>
                    <measurement group_id="O3" value="6.295" spread="4.8326"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 post-dialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.725" spread="7.6786"/>
                    <measurement group_id="O2" value="13.26" spread="13.154"/>
                    <measurement group_id="O3" value="3.101" spread="2.2190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 pre-dialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.74" spread="14.356"/>
                    <measurement group_id="O2" value="17.19" spread="13.266"/>
                    <measurement group_id="O3" value="7.843" spread="8.0807"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 post-dialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.833" spread="5.5438"/>
                    <measurement group_id="O2" value="8.408" spread="6.4361"/>
                    <measurement group_id="O3" value="2.998" spread="2.5811"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Plasma Concentrations of Vadadustat-Acyl-Glucuronide Metabolite</title>
        <description>Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session.</description>
        <time_frame>Pre-dialysis and post-dialysis on Week 2 and Week 16</time_frame>
        <population>ITT Population. Participants with available data were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Plasma Concentrations of Vadadustat-Acyl-Glucuronide Metabolite</title>
          <description>Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session.</description>
          <population>ITT Population. Participants with available data were included in the analysis.</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2 pre-dialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0136" spread="0.00611"/>
                    <measurement group_id="O2" value="0.0224" spread="0.01889"/>
                    <measurement group_id="O3" value="0.0800" spread="NA">Dispersion data is not available for a single participant</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 post-dialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0142" spread="0.01016"/>
                    <measurement group_id="O2" value="0.0095" spread="0.00246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 pre-dialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0129" spread="0.01083"/>
                    <measurement group_id="O2" value="0.0210" spread="0.00700"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 post-dialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0100" spread="0.00603"/>
                    <measurement group_id="O2" value="0.0087" spread="0.00351"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. A TEAE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. A SAE included AEs that met one or more of the following criteria/outcomes: death, lifethreatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, and congenital anomaly/birth defect.</description>
        <time_frame>Up to Week 20</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. A TEAE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. A SAE included AEs that met one or more of the following criteria/outcomes: death, lifethreatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, and congenital anomaly/birth defect.</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Changes From Baseline in Vital Signs</title>
        <description>Parameters assessed for vital signs included sitting blood pressure, pulse, respiratory rate, and body temperature. The investigator was responsible for reviewing laboratory results for clinically significant changes.</description>
        <time_frame>Up to Week 20</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Changes From Baseline in Vital Signs</title>
          <description>Parameters assessed for vital signs included sitting blood pressure, pulse, respiratory rate, and body temperature. The investigator was responsible for reviewing laboratory results for clinically significant changes.</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values</title>
        <description>Parameters assessed for laboratory values included hematology, serum chemistry, urinalysis, iron indices, C-reactive protein, lipid profile, biomarkers, and pregnancy tests. The investigator was responsible for reviewing laboratory results for clinically significant changes.</description>
        <time_frame>Up to Week 20</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values</title>
          <description>Parameters assessed for laboratory values included hematology, serum chemistry, urinalysis, iron indices, C-reactive protein, lipid profile, biomarkers, and pregnancy tests. The investigator was responsible for reviewing laboratory results for clinically significant changes.</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings</title>
        <description>A standard 12-lead ECG was performed following dosing in a supine position for approximately 5 minutes. ECGs were taken prior to vital sign assessments, circulatory access cannulation, and blood draws when possible. Clinical significance was determined by the investigator.</description>
        <time_frame>Up to Week 20</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg Once Daily (QD)</title>
            <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg QD</title>
            <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
            <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings</title>
          <description>A standard 12-lead ECG was performed following dosing in a supine position for approximately 5 minutes. ECGs were taken prior to vital sign assessments, circulatory access cannulation, and blood draws when possible. Clinical significance was determined by the investigator.</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Mean Intravenous Iron Replacement Therapy</title>
        <description>Intravenous iron was administered throughout the study to maintain ferritin levels in the range of ≥100 ng/mL to ≤1200 ng/mL.</description>
        <time_frame>Baseline, Week 8, and Week 16</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 20 (from the time of the first dose of study medication to last dose + 4 weeks of follow-up)</time_frame>
      <desc>Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, were reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>Vadadustat 300 mg Once Daily (QD)</title>
          <description>Participants received a starting dose of Vadadustat 300 milligrams (mg) QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in hemoglobin (Hgb) levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
        </group>
        <group group_id="E2">
          <title>Vadadustat 450 mg QD</title>
          <description>Participants received a starting dose of Vadadustat 450 mg QD orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
        </group>
        <group group_id="E3">
          <title>Vadadustat 450 mg 3 Times Per Week (TIW)</title>
          <description>Participants received a starting dose of Vadadustat 450 mg TIW orally for 8 weeks. Dose increases (up to a maximum of 600 mg) were allowed once every 4 weeks after the initial 8 weeks of treatment up to Week 12, based on the changes in Hgb levels for the participant. Dose of Vadadustat were reduced at any time during the 16-week treatment period, if intolerance or an excessive increase in Hgb level (Hgb level ≥13.0 g/dL) was observed.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDra 16.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula site infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Arteriovenous graft site infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Vestibular neuronitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Delayed recovery from anaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.1</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="22" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperparathyroidism secondary</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula site complication</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula site haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula thrombosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Procedural hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Akebia Therapeutics, Inc.</name_or_title>
      <organization>Akebia Therapeutics, Inc.</organization>
      <phone>+1 617-844-6128</phone>
      <email>trials@akebia.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/NCT02260193
org study id: AKB-6548-CI-0011
nct id: NCT02260193
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and
      tolerability of orally administered AKB-6548 in participants with end stage renal disease
      undergoing chronic hemodialysis.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average
time frame: Pre-dose (Screening, Second Screening, and Baseline), Week 7, and Week 8
description: Change from pre-dose average was calculated by the mid-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits.
measure: Change From Pre-dose Average in Hgb Level to The End-of-study Average
time frame: Pre-dose, Week 15, and Week 16
description: Change from pre-dose average was calculated by the end-of-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.
measure: Change From Mid-study Average in Hgb Level to The End-of-study Average
time frame: Week 7, Week 8, Week 15, and Week 16
description: Change from mid-study average was calculated by the end-of-study average minus the mid-study average. The mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits.
measure: Change From Baseline in Hgb
time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
description: Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hgb was defined as the average of the three samples obtained prior to dosing.
measure: Change From Baseline in Hematocrit
time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
description: Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hematocrit was defined as the last observation before the first dose of study medication.
measure: Change From Baseline in Red Blood Cell (RBC) Count
time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
description: Change from Baseline was calculated as the visit value minus the Baseline value. Baseline RBC Count was defined as the average of the three samples obtained prior to dosing.
measure: Change From Baseline in Absolute Reticulocyte Count
time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
description: Change from Baseline was calculated as the visit value minus the Baseline value. Baseline absolute reticulocyte count was defined as the last observation before the first dose of study medication.
measure: Change From Baseline in Percent Reticulocyte Count
time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
description: Change from Baseline was calculated as (visit value minus the Baseline value)/ Baseline value x 100. Baseline percent reticulocyte count was defined as the last observation before the first dose of study medication.
measure: Change From Baseline in Reticulocyte Hgb Content
time frame: Baseline, Week 2, Week 4, Week 8, and Week 16
description: Change from Baseline was calculated as the visit value minus the Baseline value. Baseline reticulocyte Hgb content was defined as the average of the three samples obtained prior to dosing.
measure: Change From Baseline in Ferritin
time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
description: Change from Baseline was calculated as the visit value minus the Baseline value. Baseline ferritin was defined as the last observation before the first dose of study medication.
measure: Change From Baseline in Hepcidin
time frame: Baseline, Week 8, and Week 16
description: Change from Baseline was calculated as the visit value minus the Baseline value. Baseline hepcidin was defined as the last observation before the first dose of study medication.
measure: Change From Baseline in Total Iron-Binding Capacity (TIBC)
time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
description: Change from Baseline was calculated as the visit value minus the Baseline value. Baseline TIBC was defined as the last observation before the first dose of study medication.
measure: Change From Baseline in Transferrin Saturation (TSAT)
time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
description: Change from Baseline was calculated as (visit value minus the Baseline value)/ Baseline value x 100. Baseline TSAT was defined as the last observation before the first dose of study medication.
measure: Change From Baseline in Iron
time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
description: Change from Baseline was calculated as the visit value minus the Baseline value. Baseline iron was defined as the last observation before the first dose of study medication.
measure: Number of Participants Who Received Erythropoiesis-stimulating Agent (ESA) Rescue Therapy
time frame: Up to Week 16
description: ESA rescue therapy was administered in participants with Hgb ≤12.5 g/dL, and was stopped when Hgb reached ≥13.0 g/dL.
measure: Number of Participants Who Received Blood Transfusion Rescue Therapy
time frame: Up to Week 16
description: Blood transfusion rescue therapy was administered in participants with Hgb ≤12.5 g/dL, and was stopped when Hgb reached ≥13.0 g/dL.
measure: Mean Plasma Concentrations of Vadadustat
time frame: Pre-dialysis and post-dialysis on Week 2 and Week 16
description: Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session.
measure: Mean Plasma Concentrations of Vadadustat-O-Glucuronide Metabolite
time frame: Pre-dialysis and post-dialysis on Week 2 and Week 16
description: Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session.
measure: Mean Plasma Concentrations of Vadadustat-Acyl-Glucuronide Metabolite
time frame: Pre-dialysis and post-dialysis on Week 2 and Week 16
description: Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session.
measure: Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
time frame: Up to Week 20
description: An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. A TEAE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. A SAE included AEs that met one or more of the following criteria/outcomes: death, lifethreatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, and congenital anomaly/birth defect.
measure: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
time frame: Up to Week 20
description: Parameters assessed for vital signs included sitting blood pressure, pulse, respiratory rate, and body temperature. The investigator was responsible for reviewing laboratory results for clinically significant changes.
measure: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
time frame: Up to Week 20
description: Parameters assessed for laboratory values included hematology, serum chemistry, urinalysis, iron indices, C-reactive protein, lipid profile, biomarkers, and pregnancy tests. The investigator was responsible for reviewing laboratory results for clinically significant changes.
measure: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
time frame: Up to Week 20
description: A standard 12-lead ECG was performed following dosing in a supine position for approximately 5 minutes. ECGs were taken prior to vital sign assessments, circulatory access cannulation, and blood draws when possible. Clinical significance was determined by the investigator.
measure: Mean Intravenous Iron Replacement Therapy
time frame: Baseline, Week 8, and Week 16
description: Intravenous iron was administered throughout the study to maintain ferritin levels in the range of ≥100 ng/mL to ≤1200 ng/mL.
arm group label: AKB-6548, starting dose 1
arm group type: Experimental
arm group label: AKB-6548, starting dose 2
arm group type: Experimental
arm group label: AKB-6548, starting dose 3
arm group type: Experimental
intervention type: Drug
intervention name: AKB-6548
description: Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
arm group label: AKB-6548, starting dose 1
intervention type: Drug
intervention name: AKB-6548
description: Starting dose 2. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
arm group label: AKB-6548, starting dose 2
intervention type: Drug
intervention name: AKB-6548
description: Starting dose 3. Oral dose administered three times weekly for 16 weeks. Dose adjustment based on hemoglobin levels as defined in the protocol.
arm group label: AKB-6548, starting dose 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Chief Medical Officer
role: Study Director
affiliation: Akebia Therapeutics Inc.
facility: 
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facility: 
country: United States
url: https://ir.akebia.com/static-files/0c2473ab-894a-44de-9ee9-22734dca47bf
description: Vadadustat, a Novel, Oral Treatment for Anemia of CKD, Maintains Stable Hemoglobin Levels in Dialysis Patients Converting from Erythropoiesis-Stimulating Agents
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Anemia
mesh term: Glycine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 