<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/NCT03236246</url>
  </required_header>
  <id_info>
    <org_study_id>KRX-0502-402</org_study_id>
    <nct_id>NCT03236246</nct_id>
  </id_info>
  <brief_title>KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)</brief_title>
  <acronym>COMPASS</acronym>
  <official_title>Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and Iron-Deficiency Anemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Keryx Biopharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Keryx Biopharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to assess the long-term efficacy and safety of different&#xD;
      dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects&#xD;
      with non-dialysis dependent chronic kidney disease (CKD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 4, 48-week, randomized, open-label, multicenter clinical study comprised of 2&#xD;
      periods: a 24-week Dose Titration Period, followed by a 24-week Dose Maintenance Period. The&#xD;
      study will consist of 12 scheduled clinic visits over a period of 48 weeks and additional&#xD;
      visits as needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">September 27, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Hemoglobin (Hgb) at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from a mixed model of repeated measures (MMRM), including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hgb at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Randomization to the First Increase From Baseline Hgb of at Least 0.5 Grams Per Deciliter (g/dL) During the Dose Titration Period</measure>
    <time_frame>from Randomization to Week 24</time_frame>
    <description>The Kaplan-Meier estimator of the survival function of time from randomization to the first increase from Baseline Hgb of at least 0.5 g/dL for each of the two starting dose treatment groups were obtained.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Transferrin Saturation (TSAT) at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in TSAT at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ferritin at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ferritin at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Phosphate at Week 24</measure>
    <time_frame>Baseline; up to Week 24</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Phosphate at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in eGFR at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Bicarbonate at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Bicarbonate at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Intact Parathyroid Hormone (iPTH) at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope analysis of covariance (ANCOVA) model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in iPTH at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in C-terminal Fibroblast Growth Factor 23 (FGF23) at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in C-terminal FGF23 at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Scores for the Work Productivity and Activity Impairment (WPAI) Questionnaire Adapted for Anemia Associated With Chronic Kidney Disease (CKD) at Week 24: Work-associated Measures</measure>
    <time_frame>Baseline; Week 24</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Work-associated Measures</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 24: Activity Impairment</measure>
    <time_frame>Baseline; Week 24</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Activity Impairment</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Score at Week 24</measure>
    <time_frame>Baseline; Week 24</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue Scale Score at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hospitalizations for Participants Who Entered the Dose Maintenance Period</measure>
    <time_frame>up to Week 48</time_frame>
    <description>A hospitalization is defined as admission to the hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Hospitalizations for Participants Who Entered the Dose Maintenance Period</measure>
    <time_frame>up to Week 48</time_frame>
    <description>A hospitalization is defined as admission to the hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Treatment-emergent Adverse Event (TEAE) for Participants Who Entered the Dose Maintenance Period</measure>
    <time_frame>up to Week 48</time_frame>
    <description>Treatment-emergent adverse events are defined as adverse events that began after the first administration of study medication or pre-existing conditions that worsened after the first dose of study medication.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">206</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <condition>Iron Deficiency Anemia</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>KRX-0502 1 tablet thrice daily (TID) with meals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KRX-0502</intervention_name>
    <description>Oral ferric citrate with meals</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <other_name>ferric citrate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Estimated glomerular filtration rate ≥20 mL/min and &lt;60 mL/min&#xD;
&#xD;
          -  Hgb ≥8.5 g/dL and ≤11.5 g/dL&#xD;
&#xD;
          -  Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%&#xD;
&#xD;
          -  Serum intact parathyroid hormone ≤600 pg/mL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serum phosphate &lt;3.0 mg/dL&#xD;
&#xD;
          -  Intravenous (IV) iron administered within 4 weeks prior to Screening&#xD;
&#xD;
          -  Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening&#xD;
&#xD;
          -  Blood transfusion within 4 weeks prior to Screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Keryx Biopharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Kidney Disease and Hypertension center: AKDHC Medical Research Services, LLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Institute of Renal Research</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Institute of Renal Research</name>
      <address>
        <city>El Centro</city>
        <state>California</state>
        <zip>92243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Institute of Renal Research</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <zip>92064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Denver Nephrologists, P.C.</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Kidney Group</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kidney and Hypertension Specialists of Miami, P.A.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Clinical Research Institute, LLC</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renal Associates, LLC</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research by Design, LLC</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60643</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Mississippi Medical Research, LLC</name>
      <address>
        <city>Gulfport</city>
        <state>Mississippi</state>
        <zip>39501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Consultants</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sierra Nevada Nephrology Consultants</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hypertension and Nephrology Association</name>
      <address>
        <city>Eatontown</city>
        <state>New Jersey</state>
        <zip>07724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Kidney/HTN Research</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain Kidney &amp; Hypertension Associates</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metrolina Nephrology Associates, PA</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Nephrology Associates</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Nephrology Associates</name>
      <address>
        <city>Jacksonville</city>
        <state>North Carolina</state>
        <zip>28546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Nephrology Associates</name>
      <address>
        <city>New Bern</city>
        <state>North Carolina</state>
        <zip>28562</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Nephrology</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia Nephrology Associates, PA</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Carolina Nephrology &amp; Hypertension Center, Inc</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nephrology Associates, P.C.</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Management, Inc.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Management, Inc.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P &amp; I Clinical Research, LLC</name>
      <address>
        <city>Lufkin</city>
        <state>Texas</state>
        <zip>75904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Advancement Center, PLLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <results_first_submitted>February 2, 2021</results_first_submitted>
  <results_first_submitted_qc>March 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 12, 2021</results_first_posted>
  <last_update_submitted>March 10, 2021</last_update_submitted>
  <last_update_submitted_qc>March 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT03236246/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 4, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT03236246/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>KRX-0502 3 g/Day</title>
          <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
        </group>
        <group group_id="P2">
          <title>KRX-0502 4 g/Day</title>
          <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>24-Week Dose Titration Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="104"/>
                <participants group_id="P2" count="102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Drug Non-Compliance</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator Judgement</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Prohibited Therapy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Start Chronic Dialysis/Kidney Transplant</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" 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="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Captured as Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>24-Week Dose Maintenance Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="76">Not all participants completing the Dose Titration Period opted to enter the Dose Maintenance Period</participants>
                <participants group_id="P2" count="72">Not all participants completing the Dose Titration Period opted to enter the Dose Maintenance Period</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Prohibited Therapy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set: all participants who took at least 1 dose of study medication</population>
      <group_list>
        <group group_id="B1">
          <title>KRX-0502 3 g/Day</title>
          <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
        </group>
        <group group_id="B2">
          <title>KRX-0502 4 g/Day</title>
          <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="104"/>
            <count group_id="B2" value="101"/>
            <count group_id="B3" value="205"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="104"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="205"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.3" spread="11.22"/>
                    <measurement group_id="B2" value="69.9" spread="9.81"/>
                    <measurement group_id="B3" value="69.1" spread="10.55"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="104"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="205"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="69"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="104"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="205"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="125"/>
                  </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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Continous: Dose Maintenance Period</title>
          <population>Baseline data are reported for the Dose Maintenance Period, a subset of participants in the Safety Analysis Set starting the Dose Titration Period.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="76"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.6" spread="11.57"/>
                    <measurement group_id="B2" value="69.6" spread="8.94"/>
                    <measurement group_id="B3" value="68.6" spread="10.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male: Dose Maintenance Period</title>
          <population>Baseline data are reported for the Dose Maintenance Period, a subset of participants in the Safety Analysis Set starting the Dose Titration Period.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="76"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB): Dose Maintenance Period</title>
          <population>Baseline data are reported for the Dose Maintenance Period, a subset of participants in the Safety Analysis Set starting the Dose Titration Period.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="76"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin</title>
          <population>Data are reported for Per-Protocol Analysis Set members, comprised of participants in the Full Analysis Set (FAS) (randomized participants who took &gt;=1 dose of study medication and had &gt;=1 post-randomization efficacy measurement) who met the study eligibility requirements and had no major protocol deviations that affected the validity of the efficacy measurements.</population>
          <units>grams per deciliter (g/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="97"/>
                    <count group_id="B2" value="86"/>
                    <count group_id="B3" value="183"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.40" spread="0.749"/>
                    <measurement group_id="B2" value="10.51" spread="0.739"/>
                    <measurement group_id="B3" value="10.45" spread="0.744"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hemoglobin (Hgb) at Week 24</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from a mixed model of repeated measures (MMRM), including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Per-Protocol Analysis Set: participants in the Full Analysis Set (FAS) (randomized par. who took &gt;=1 dose of study medication and had &gt;=1 post-randomization efficacy measurement) who met the study eligibility requirements and had no major protocol deviations that affected the validity of the efficacy measurements. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin (Hgb) at Week 24</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from a mixed model of repeated measures (MMRM), including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
          <population>Per-Protocol Analysis Set: participants in the Full Analysis Set (FAS) (randomized par. who took &gt;=1 dose of study medication and had &gt;=1 post-randomization efficacy measurement) who met the study eligibility requirements and had no major protocol deviations that affected the validity of the efficacy measurements. Only participants with available data were analyzed.</population>
          <units>grams per deciliter (g/dL)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="0.101"/>
                    <measurement group_id="O2" value="0.70" spread="0.104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hgb at Week 48</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hgb at Week 48</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>g/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.61" spread="0.114"/>
                    <measurement group_id="O2" value="0.58" spread="0.119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Randomization to the First Increase From Baseline Hgb of at Least 0.5 Grams Per Deciliter (g/dL) During the Dose Titration Period</title>
        <description>The Kaplan-Meier estimator of the survival function of time from randomization to the first increase from Baseline Hgb of at least 0.5 g/dL for each of the two starting dose treatment groups were obtained.</description>
        <time_frame>from Randomization to Week 24</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with data available at Week 24 were analyzed. A participant's time to first hemoglobin value &gt;= 0.5 above the Baseline value was censored at the study day of the participant's last hemoglobin assessment on or before the Week 24 visit.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomization to the First Increase From Baseline Hgb of at Least 0.5 Grams Per Deciliter (g/dL) During the Dose Titration Period</title>
          <description>The Kaplan-Meier estimator of the survival function of time from randomization to the first increase from Baseline Hgb of at least 0.5 g/dL for each of the two starting dose treatment groups were obtained.</description>
          <population>Per-Protocol Analysis Set. Only participants with data available at Week 24 were analyzed. A participant's time to first hemoglobin value &gt;= 0.5 above the Baseline value was censored at the study day of the participant's last hemoglobin assessment on or before the Week 24 visit.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.0" lower_limit="57.0" upper_limit="89.0"/>
                    <measurement group_id="O2" value="57.0" lower_limit="29.0" upper_limit="85.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Transferrin Saturation (TSAT) at Week 24</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Transferrin Saturation (TSAT) at Week 24</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>percentage of transferrin saturation</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.30" spread="1.023"/>
                    <measurement group_id="O2" value="6.85" spread="1.073"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in TSAT at Week 48</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in TSAT at Week 48</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>percentage of transferrin saturation</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.97" spread="1.053"/>
                    <measurement group_id="O2" value="10.63" spread="1.113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Ferritin at Week 24</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ferritin at Week 24</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>nanograms per millilier (ng/mL)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136.63" spread="13.315"/>
                    <measurement group_id="O2" value="155.28" spread="14.037"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Ferritin at Week 48</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ferritin at Week 48</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>ng/mL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="251.44" spread="29.417"/>
                    <measurement group_id="O2" value="343.27" spread="31.148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Phosphate at Week 24</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
        <time_frame>Baseline; up to Week 24</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Phosphate at Week 24</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>milligrams per deciliter (mg/dL)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.19" spread="0.065"/>
                    <measurement group_id="O2" value="-0.25" spread="0.069"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Phosphate at Week 48</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Phosphate at Week 48</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.075"/>
                    <measurement group_id="O2" value="-0.20" spread="0.079"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>ml/minute/1.73 meters cubed (m^3)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.08" spread="0.836"/>
                    <measurement group_id="O2" value="-1.53" spread="0.0882"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in eGFR at Week 48</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in eGFR at Week 48</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>ml/minute/1.73 m^3</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.85" spread="0.977"/>
                    <measurement group_id="O2" value="-2.20" spread="1.035"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Bicarbonate at Week 24</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Bicarbonate at Week 24</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>milliquivalent (mEq)/Liter (L)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="0.296"/>
                    <measurement group_id="O2" value="-0.05" spread="0.312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Bicarbonate at Week 48</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Bicarbonate at Week 48</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>mEq/L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.328"/>
                    <measurement group_id="O2" value="-0.51" spread="0.345"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Intact Parathyroid Hormone (iPTH) at Week 24</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope analysis of covariance (ANCOVA) model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.</description>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Intact Parathyroid Hormone (iPTH) at Week 24</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope analysis of covariance (ANCOVA) model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>picograms per milliliter (pg/mL)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.64" spread="4.547"/>
                    <measurement group_id="O2" value="0.39" spread="4.647"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in iPTH at Week 48</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Per-Protocol Analysis Set. Only participants who completed their Week 48 Visit were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in iPTH at Week 48</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.</description>
          <population>Per-Protocol Analysis Set. Only participants who completed their Week 48 Visit were included in this analysis.</population>
          <units>pg/mL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.49" spread="5.385"/>
                    <measurement group_id="O2" value="5.74" spread="5.824"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in C-terminal Fibroblast Growth Factor 23 (FGF23) at Week 24</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.</description>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in C-terminal Fibroblast Growth Factor 23 (FGF23) at Week 24</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>relative units (RU)/mL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-94.78" spread="26.393"/>
                    <measurement group_id="O2" value="-63.22" spread="26.392"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in C-terminal FGF23 at Week 48</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Per-Protocol Analysis Set. Only participants who completed their Week 48 Visit were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in C-terminal FGF23 at Week 48</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.</description>
          <population>Per-Protocol Analysis Set. Only participants who completed their Week 48 Visit were included in this analysis.</population>
          <units>RU/mL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-85.70" spread="23.029"/>
                    <measurement group_id="O2" value="-80.34" spread="24.370"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 24</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.</description>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 24</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>pg/mL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.23" spread="8.106"/>
                    <measurement group_id="O2" value="-2.01" spread="8.286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 48</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Per-Protocol Analysis Set. Only participants who completed their Week 48 Visit are included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 48</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.</description>
          <population>Per-Protocol Analysis Set. Only participants who completed their Week 48 Visit are included in this analysis.</population>
          <units>pg/mL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.52" spread="14.741"/>
                    <measurement group_id="O2" value="10.15" spread="16.086"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Scores for the Work Productivity and Activity Impairment (WPAI) Questionnaire Adapted for Anemia Associated With Chronic Kidney Disease (CKD) at Week 24: Work-associated Measures</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.</description>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data who were currently employed (working for pay) were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Scores for the Work Productivity and Activity Impairment (WPAI) Questionnaire Adapted for Anemia Associated With Chronic Kidney Disease (CKD) at Week 24: Work-associated Measures</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data who were currently employed (working for pay) were analyzed.</population>
          <units>percentage of score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percent Work Time Missed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.000"/>
                    <measurement group_id="O2" value="-3.19" spread="9.222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent Impairment while Working</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.00" spread="25.884"/>
                    <measurement group_id="O2" value="4.00" spread="30.258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent Overall Work Impairment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.00" spread="25.884"/>
                    <measurement group_id="O2" value="1.40" spread="26.842"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Work-associated Measures</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data who were currently employed (working for pay) were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Work-associated Measures</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data who were currently employed (working for pay) were analyzed.</population>
          <units>percentage of score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percent Work Time Missed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.000"/>
                    <measurement group_id="O2" value="-3.48" spread="7.412"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent Impairment while Working</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.43" spread="16.762"/>
                    <measurement group_id="O2" value="7.78" spread="29.486"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percent Overall Work Impairment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.43" spread="16.762"/>
                    <measurement group_id="O2" value="4.71" spread="24.601"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 24: Activity Impairment</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.</description>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 24: Activity Impairment</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>percentage of score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.03" spread="28.753"/>
                    <measurement group_id="O2" value="-6.34" spread="31.769"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Activity Impairment</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Activity Impairment</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>percentage of score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.71" spread="36.859"/>
                    <measurement group_id="O2" value="-6.72" spread="36.227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Score at Week 24</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.</description>
        <time_frame>Baseline; Week 24</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Score at Week 24</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.22" spread="10.986"/>
                    <measurement group_id="O2" value="4.35" spread="10.047"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue Scale Score at Week 48</title>
        <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue Scale Score at Week 48</title>
          <description>Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.</description>
          <population>Per-Protocol Analysis Set. Only participants with available data were analyzed.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.49" spread="11.817"/>
                    <measurement group_id="O2" value="3.68" spread="9.954"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Hospitalizations for Participants Who Entered the Dose Maintenance Period</title>
        <description>A hospitalization is defined as admission to the hospital.</description>
        <time_frame>up to Week 48</time_frame>
        <population>Per-Protocol Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Hospitalizations for Participants Who Entered the Dose Maintenance Period</title>
          <description>A hospitalization is defined as admission to the hospital.</description>
          <population>Per-Protocol Analysis Set</population>
          <units>hospitalizations</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Hospitalizations for Participants Who Entered the Dose Maintenance Period</title>
        <description>A hospitalization is defined as admission to the hospital.</description>
        <time_frame>up to Week 48</time_frame>
        <population>Per-Protocol Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Hospitalizations for Participants Who Entered the Dose Maintenance Period</title>
          <description>A hospitalization is defined as admission to the hospital.</description>
          <population>Per-Protocol Analysis Set</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.08" spread="2.499"/>
                    <measurement group_id="O2" value="3.91" spread="0.980"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Treatment-emergent Adverse Event (TEAE) for Participants Who Entered the Dose Maintenance Period</title>
        <description>Treatment-emergent adverse events are defined as adverse events that began after the first administration of study medication or pre-existing conditions that worsened after the first dose of study medication.</description>
        <time_frame>up to Week 48</time_frame>
        <population>Safety Analysis Set: all participants who took at least 1 dose of study medication</population>
        <group_list>
          <group group_id="O1">
            <title>KRX-0502 3 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
          <group group_id="O2">
            <title>KRX-0502 4 g/Day</title>
            <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Treatment-emergent Adverse Event (TEAE) for Participants Who Entered the Dose Maintenance Period</title>
          <description>Treatment-emergent adverse events are defined as adverse events that began after the first administration of study medication or pre-existing conditions that worsened after the first dose of study medication.</description>
          <population>Safety Analysis Set: all participants who took 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="104"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>from the time of informed consent up to 48 weeks</time_frame>
      <desc>Treatment-emergent adverse events, defined as adverse events that began after the first administration of study medication or pre-existing conditions that worsened after the first dose of study medication, were collected in members of the Safety Analysis Set (comprised as all participants who took at least 1 dose of study medication). Data are reported for those participants who entered the Dose Maintenance Period.</desc>
      <group_list>
        <group group_id="E1">
          <title>KRX-0502 3 g/Day</title>
          <description>Participants were randomized to receive KRX-0502 3 grams per day (g/day), administered as 1 tablet 3 times daily (TID) (total of 3 tablets/day) with meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the hemoglobin (Hgb) increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
        </group>
        <group group_id="E2">
          <title>KRX-0502 4 g/Day</title>
          <description>Participants were randomized to receive KRX-0502 4 g/day, administered as 2 tablets twice daily (BID) with the larger of 2 daily meals, in the 24-week Dose Titration Period. Scheduled study drug dose adjustment occurred at Week 12 and was based upon the Hgb increase relative to Baseline and an Hgb threshold. Participants who completed the 24-week Dose Titration Period were eligible to enter the 24-week Dose Maintenance Period. During the Dose Maintenance Period, participants continued on the dose determined during the Dose Titration Period. The maximum dose was the dose determined at Week 12.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Non-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="3" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Ileus paralytic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Internal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Chest wall abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Cystitis escherichia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Enterobacter sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Escherichia pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Gastritis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Gastroenteritis salmonella</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Infectious colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Necrotising fasciitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Viral sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Procedural intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Ureteric injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Anticoagulation drug level above therapeutic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Hyperglycaemic hyperosmolar nonketotic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain stem stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>End stage renal disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Malignant hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Non-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="58" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="59" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Faeces discoloured</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="101"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Keryx Medical Information</name_or_title>
      <organization>Keryx</organization>
      <phone>1-844-44-KERYX (844-445-3799)</phone>
      <email>medicalinfo@keryx.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/NCT03236246
org study id: KRX-0502-402
nct id: NCT03236246
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The objectives of this study are to assess the long-term efficacy and safety of different
      dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects
      with non-dialysis dependent chronic kidney disease (CKD).
This is a Phase 4, 48-week, randomized, open-label, multicenter clinical study comprised of 2
      periods: a 24-week Dose Titration Period, followed by a 24-week Dose Maintenance Period. The
      study will consist of 12 scheduled clinic visits over a period of 48 weeks and additional
      visits as needed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Hemoglobin (Hgb) at Week 24
time frame: Baseline; Week 24
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from a mixed model of repeated measures (MMRM), including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
measure: Change From Baseline in Hgb at Week 48
time frame: Baseline; Week 48
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
measure: Time From Randomization to the First Increase From Baseline Hgb of at Least 0.5 Grams Per Deciliter (g/dL) During the Dose Titration Period
time frame: from Randomization to Week 24
description: The Kaplan-Meier estimator of the survival function of time from randomization to the first increase from Baseline Hgb of at least 0.5 g/dL for each of the two starting dose treatment groups were obtained.
measure: Change From Baseline in Transferrin Saturation (TSAT) at Week 24
time frame: Baseline; Week 24
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
measure: Change From Baseline in TSAT at Week 48
time frame: Baseline; Week 48
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
measure: Change From Baseline in Ferritin at Week 24
time frame: Baseline; Week 24
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
measure: Change From Baseline in Ferritin at Week 48
time frame: Baseline; Week 48
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
measure: Change From Baseline in Serum Phosphate at Week 24
time frame: Baseline; up to Week 24
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
measure: Change From Baseline in Serum Phosphate at Week 48
time frame: Baseline; Week 48
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
measure: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
time frame: Baseline; Week 24
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
measure: Change From Baseline in eGFR at Week 48
time frame: Baseline; Week 48
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
measure: Change From Baseline in Bicarbonate at Week 24
time frame: Baseline; Week 24
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
measure: Change From Baseline in Bicarbonate at Week 48
time frame: Baseline; Week 48
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
measure: Change From Baseline in Intact Parathyroid Hormone (iPTH) at Week 24
time frame: Baseline; Week 24
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope analysis of covariance (ANCOVA) model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.
measure: Change From Baseline in iPTH at Week 48
time frame: Baseline; Week 48
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
measure: Change From Baseline in C-terminal Fibroblast Growth Factor 23 (FGF23) at Week 24
time frame: Baseline; Week 24
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
measure: Change From Baseline in C-terminal FGF23 at Week 48
time frame: Baseline; Week 48
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
measure: Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 24
time frame: Baseline; Week 24
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.
measure: Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 48
time frame: Baseline; Week 48
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
measure: Change From Baseline Scores for the Work Productivity and Activity Impairment (WPAI) Questionnaire Adapted for Anemia Associated With Chronic Kidney Disease (CKD) at Week 24: Work-associated Measures
time frame: Baseline; Week 24
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
measure: Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Work-associated Measures
time frame: Baseline; Week 48
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
measure: Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 24: Activity Impairment
time frame: Baseline; Week 24
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
measure: Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Activity Impairment
time frame: Baseline; Week 48
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Score at Week 24
time frame: Baseline; Week 24
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue Scale Score at Week 48
time frame: Baseline; Week 48
description: Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.
measure: Number of Hospitalizations for Participants Who Entered the Dose Maintenance Period
time frame: up to Week 48
description: A hospitalization is defined as admission to the hospital.
measure: Duration of Hospitalizations for Participants Who Entered the Dose Maintenance Period
time frame: up to Week 48
description: A hospitalization is defined as admission to the hospital.
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) for Participants Who Entered the Dose Maintenance Period
time frame: up to Week 48
description: Treatment-emergent adverse events are defined as adverse events that began after the first administration of study medication or pre-existing conditions that worsened after the first dose of study medication.
arm group label: Group 1
arm group type: Experimental
description: KRX-0502 1 tablet thrice daily (TID) with meals
arm group label: Group 2
arm group type: Experimental
description: KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals
intervention type: Drug
intervention name: KRX-0502
description: Oral ferric citrate with meals
arm group label: Group 1
arm group label: Group 2
other name: ferric citrate
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Keryx Biopharmaceuticals
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country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 