<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/NCT02253654</url>
  </required_header>
  <id_info>
    <org_study_id>20110208</org_study_id>
    <nct_id>NCT02253654</nct_id>
  </id_info>
  <brief_title>Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis</brief_title>
  <official_title>A Randomized, Multicenter, Double-blind Study Evaluating Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare two different dosing methods of epoetin alfa and&#xD;
      their effectiveness in maintaining hemoglobin levels between 10.0 to 11.0 g/dL in in patients&#xD;
      with chronic kidney disease (CKD) receiving hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2015</start_date>
  <completion_date type="Actual">May 25, 2016</completion_date>
  <primary_completion_date type="Actual">April 27, 2016</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period</measure>
    <time_frame>The evaluation period (weeks 13-37)</time_frame>
    <description>Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin Concentration at Each Visit</measure>
    <time_frame>Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Transfusion Events Overall and During Each Study Period</measure>
    <time_frame>Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41</time_frame>
    <description>The percentage of participants who received red blood cell (RBC) transfusions during the study and during each study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin Rate of Change at Each Visit</measure>
    <time_frame>Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37</time_frame>
    <description>Hemoglobin rate of change (ROC) was calculated for each visit using the following formula: ROC = (current visit hemoglobin value - previous visit hemoglobin value) / number of days between each visit * 14. A positive value indicates a rate of rise and a negative value indicates a rate of decline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin Intra-subject Variability</measure>
    <time_frame>The evaluation period (weeks 13 to 37)</time_frame>
    <description>Intra-subject variability was defined for each participant as the standard deviation (SD) of all of the hemoglobin concentrations during the evaluation period for the participant. The mean intra-subject SD for all participants is the sum of the intra-subject SDs divided by the total number of participants evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Hemoglobin Excursions at Each Visit</measure>
    <time_frame>Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37</time_frame>
    <description>An excursion is identified as an event when a hemoglobin concentration fell below or exceeded the pre-specified thresholds of: - &lt; 9.0 g/dL, or - &gt; 11.0 g/dL, or - &gt; 12.0 g/dL. The percentage of participants with any excursions and excursions in each subcategory at each time point and overall during the study are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weekly Epoetin Alfa Dose at Each Visit</measure>
    <time_frame>Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of RBC Units Transfused Overall and During Each Study Period</measure>
    <time_frame>Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41</time_frame>
    <description>The number of red blood cell (RBC) units transfused during the study and during each study period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">216</enrollment>
  <condition>Renal Insufficiency, Chronic</condition>
  <condition>Anemia</condition>
  <condition>Renal Dialysis</condition>
  <condition>Erythrocyte Transfusion</condition>
  <arm_group>
    <arm_group_label>Epoetin alfa Alternative Titration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epoetin alfa USPI Titration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epoetin alfa</intervention_name>
    <description>Administered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.</description>
    <arm_group_label>Epoetin alfa Alternative Titration</arm_group_label>
    <arm_group_label>Epoetin alfa USPI Titration</arm_group_label>
    <other_name>Epogen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained prior to initiation of any study-specific&#xD;
             activities/procedures&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Prescribed hemodialysis three times a week (TIW) for ≥ 12 weeks prior to randomization&#xD;
&#xD;
          -  Prescribed IV administration of epoetin alfa TIW for ≥ 12 weeks prior to randomization&#xD;
&#xD;
          -  Prescribed ≥ 3000 Units/week (ie, ≥ 1000 Units/administration) and &lt; 90,000 Units/week&#xD;
             (ie, &lt; 30,000 Units/administration) of epoetin alfa during the 4 weeks prior to&#xD;
             randomization&#xD;
&#xD;
          -  Received ≥ 4 doses of epoetin alfa during the 2 weeks prior to randomization&#xD;
&#xD;
          -  Hemoglobin concentration ≤ 11.0 g/dL, per the most recent local laboratory value&#xD;
             obtained during the 2 weeks prior to randomization&#xD;
&#xD;
          -  Hemoglobin concentration ≤ 11.0 g/dL, at the screening visit, using the hemoglobin&#xD;
             point of care device provided by Amgen&#xD;
&#xD;
          -  Iron replete, defined as a transferrin saturation (TSAT) ≥ 20% and a ferritin ≥ 100&#xD;
             ng/mL, per the most recent local laboratory value obtained during the 4 weeks prior to&#xD;
             randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently receiving treatment in another investigational device or drug study, or less&#xD;
             than 30 days since ending treatment on another investigational device or drug study(s)&#xD;
             prior to randomization&#xD;
&#xD;
          -  Other investigational procedures while participating in this study are excluded&#xD;
&#xD;
          -  Systemic hematologic disease (eg, sickle cell anemia, myelodysplastic syndrome,&#xD;
             hematologic malignancy)&#xD;
&#xD;
          -  Current or prior malignancy within 5 years of randomization, with the exception of&#xD;
             non-melanoma skin cancers, cervical or breast ductal carcinoma in situ&#xD;
&#xD;
          -  Treatment for any malignancy (eg, radiation, chemotherapy, hormone therapy or&#xD;
             biologics) within 5 years of randomization, with the exception of locally excised&#xD;
             non-melanoma skin cancers, cervical or breast ductal carcinoma in situ&#xD;
&#xD;
          -  Subject is currently pregnant or planning to become pregnant during treatment and for&#xD;
             30 days after the end of treatment&#xD;
&#xD;
          -  Subject is currently breast feeding or planning on breast feeding during treatment and&#xD;
             for 30 days after the end of treatment&#xD;
&#xD;
          -  Females of reproductive potential who are not willing to use an acceptable method of&#xD;
             effective contraception during treatment and for at least 30 days after the end of&#xD;
             treatment&#xD;
&#xD;
          -  Currently receiving IV antibiotics&#xD;
&#xD;
          -  Currently receiving systemic immunosuppressive therapy known to cause anemia,&#xD;
             including treatment for active hepatitis (eg, azathioprine, mycophenolate mofetil, ≥&#xD;
             10 mg prednisone [or equivalent]/day, interferon)&#xD;
&#xD;
          -  Known human immunodeficiency virus (HIV) positive&#xD;
&#xD;
          -  Known neutralizing anti-erythropoietic protein antibodies&#xD;
&#xD;
          -  Known sensitivity to epoetin alfa&#xD;
&#xD;
          -  Subject likely to not be available to complete all protocol-required study visits or&#xD;
             procedures, and/or to comply with all required study procedures (eg, planned vacations&#xD;
             where away from dialysis unit for more than 2 weeks) to the best of the subject and&#xD;
             investigator's knowledge&#xD;
&#xD;
          -  History or evidence of any other clinically significant disorder, condition or disease&#xD;
             (with the exception of those outlined above) that, in the opinion of the investigator&#xD;
             or Amgen physician, if consulted, would pose a risk to subject safety or interfere&#xD;
             with the study evaluation, procedures or completion&#xD;
&#xD;
          -  Previously entered this study&#xD;
&#xD;
          -  Occurrence of any of the following within 8 weeks prior to randomization:&#xD;
&#xD;
               -  Seizure&#xD;
&#xD;
               -  Clinically relevant active bleeding (eg, gastrointestinal bleed)&#xD;
&#xD;
               -  RBC transfusion&#xD;
&#xD;
               -  Any hospitalization or observational stay &gt; 24 hours&#xD;
&#xD;
          -  Uncontrolled hypertension, per the investigator within the 4 weeks prior to&#xD;
             randomization&#xD;
&#xD;
          -  Expected or scheduled solid organ transplant(eg, kidney) within 40 weeks after&#xD;
             randomization&#xD;
&#xD;
          -  Expected or scheduled to change dialysis modality (eg, peritoneal dialysis, home&#xD;
             hemodialysis) within 40 weeks after randomization&#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>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cerritos</city>
        <state>California</state>
        <zip>90703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montebello</city>
        <state>California</state>
        <zip>90640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Simi Valley</city>
        <state>California</state>
        <zip>93065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vacaville</city>
        <state>California</state>
        <zip>95687</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami Gardens</city>
        <state>Florida</state>
        <zip>33169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Statesboro</city>
        <state>Georgia</state>
        <zip>30458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Merrillville</city>
        <state>Indiana</state>
        <zip>46410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Michigan City</city>
        <state>Indiana</state>
        <zip>46360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pontiac</city>
        <state>Michigan</state>
        <zip>48341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Roseville</city>
        <state>Michigan</state>
        <zip>48066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Astoria</city>
        <state>New York</state>
        <zip>11102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rosedale</city>
        <state>New York</state>
        <zip>11422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>The Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Carrboro</city>
        <state>North Carolina</state>
        <zip>27510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Meadville</city>
        <state>Pennsylvania</state>
        <zip>16335</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hampton</city>
        <state>Virginia</state>
        <zip>23666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toa Baja</city>
        <zip>00949</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <results_first_submitted>April 3, 2017</results_first_submitted>
  <results_first_submitted_qc>April 3, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 12, 2017</results_first_posted>
  <last_update_submitted>May 18, 2017</last_update_submitted>
  <last_update_submitted_qc>May 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Kidney Disease</keyword>
  <keyword>Anemia</keyword>
  <keyword>Hemodialysis</keyword>
  <keyword>Red Blood Cell Transfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at 31 centers in the United States. Participants were enrolled from 01 April 2015 to 17 August 2015.</recruitment_details>
      <pre_assignment_details>Eligible participants with anemia and chronic kidney disease who were receiving hemodialysis were randomized in a 1:1 ratio to 1 of 2 dosing algorithms.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Epoetin Alfa Alternative Titration</title>
          <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.</description>
        </group>
        <group group_id="P2">
          <title>Epoetin Alfa USPI Titration</title>
          <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="104"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Decision by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did Not Receive Study Treatment</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants</population>
      <group_list>
        <group group_id="B1">
          <title>Epoetin Alfa Alternative Titration</title>
          <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.</description>
        </group>
        <group group_id="B2">
          <title>Epoetin Alfa USPI Titration</title>
          <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.</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="108"/>
            <count group_id="B2" value="108"/>
            <count group_id="B3" value="216"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.9" spread="13.3"/>
                    <measurement group_id="B2" value="58.7" spread="14.2"/>
                    <measurement group_id="B3" value="59.8" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hispanic/Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic/Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period</title>
        <description>Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant.</description>
        <time_frame>The evaluation period (weeks 13-37)</time_frame>
        <population>The Primary Analysis Set which consists of all randomized participants who had at least 6 hemoglobin measurements during the evaluation period while on study and receiving investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Epoetin Alfa Alternative Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.</description>
          </group>
          <group group_id="O2">
            <title>Epoetin Alfa USPI Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period</title>
          <description>Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant.</description>
          <population>The Primary Analysis Set which consists of all randomized participants who had at least 6 hemoglobin measurements during the evaluation period while on study and receiving investigational product.</population>
          <units>percentage of hemoglobin measurements</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.41" spread="2.39"/>
                    <measurement group_id="O2" value="46.02" spread="2.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The difference between treatment groups for the percent of hemoglobin measurements within 10.0 to 11.0 g/dL during the evaluation period was tested using a 1-sided t-test with a significance level of 0.025.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.46</p_value>
            <method>t-test, 1 sided</method>
            <param_type>Treatment difference</param_type>
            <param_value>0.39</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.53</dispersion_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>-6.58</ci_lower_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemoglobin Concentration at Each Visit</title>
        <time_frame>Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37</time_frame>
        <population>Primary analysis set with available data at each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Epoetin Alfa Alternative Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.</description>
          </group>
          <group group_id="O2">
            <title>Epoetin Alfa USPI Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Hemoglobin Concentration at Each Visit</title>
          <population>Primary analysis set with available data at each time point</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.15" spread="0.66"/>
                    <measurement group_id="O2" value="10.04" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.54" spread="0.88"/>
                    <measurement group_id="O2" value="10.34" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5 (n = 89, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.66" spread="0.93"/>
                    <measurement group_id="O2" value="10.51" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7 (n = 88, 97)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.45" spread="1.02"/>
                    <measurement group_id="O2" value="10.28" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.32" spread="1.16"/>
                    <measurement group_id="O2" value="9.97" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11 (n = 88, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.33" spread="1.05"/>
                    <measurement group_id="O2" value="10.15" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.28" spread="1.04"/>
                    <measurement group_id="O2" value="9.99" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.46" spread="1.38"/>
                    <measurement group_id="O2" value="9.98" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.20" spread="1.05"/>
                    <measurement group_id="O2" value="10.01" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 19 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.37" spread="1.14"/>
                    <measurement group_id="O2" value="9.94" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 21 (n = 87, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.33" spread="1.01"/>
                    <measurement group_id="O2" value="9.92" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 23 (n = 88, 98)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.46" spread="1.05"/>
                    <measurement group_id="O2" value="10.03" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25 (n = 87, 98)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.56" spread="1.00"/>
                    <measurement group_id="O2" value="9.94" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 27 (n = 88, 94)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.32" spread="1.10"/>
                    <measurement group_id="O2" value="9.97" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 29 (n =89, 92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.34" spread="1.01"/>
                    <measurement group_id="O2" value="10.02" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 31 (n = 85, 89)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.34" spread="0.95"/>
                    <measurement group_id="O2" value="9.96" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 33 (n = 86, 90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.18" spread="1.00"/>
                    <measurement group_id="O2" value="10.05" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 35 (n = 87, 88)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.12" spread="1.23"/>
                    <measurement group_id="O2" value="9.94" spread="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 37 (n = 87, 93)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.10" spread="1.11"/>
                    <measurement group_id="O2" value="9.86" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Transfusion Events Overall and During Each Study Period</title>
        <description>The percentage of participants who received red blood cell (RBC) transfusions during the study and during each study period.</description>
        <time_frame>Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41</time_frame>
        <population>Primary analysis set with available data in each study period</population>
        <group_list>
          <group group_id="O1">
            <title>Epoetin Alfa Alternative Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.</description>
          </group>
          <group group_id="O2">
            <title>Epoetin Alfa USPI Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Transfusion Events Overall and During Each Study Period</title>
          <description>The percentage of participants who received red blood cell (RBC) transfusions during the study and during each study period.</description>
          <population>Primary analysis set with available data in each study period</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                    <measurement group_id="O2" value="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Titration Period (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Evaluation Period (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6"/>
                    <measurement group_id="O2" value="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Safety Follow-up Period (n = 83, 90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                    <measurement group_id="O2" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemoglobin Rate of Change at Each Visit</title>
        <description>Hemoglobin rate of change (ROC) was calculated for each visit using the following formula: ROC = (current visit hemoglobin value - previous visit hemoglobin value) / number of days between each visit * 14. A positive value indicates a rate of rise and a negative value indicates a rate of decline.</description>
        <time_frame>Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37</time_frame>
        <population>Primary analysis set with available data at each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Epoetin Alfa Alternative Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.</description>
          </group>
          <group group_id="O2">
            <title>Epoetin Alfa USPI Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Hemoglobin Rate of Change at Each Visit</title>
          <description>Hemoglobin rate of change (ROC) was calculated for each visit using the following formula: ROC = (current visit hemoglobin value - previous visit hemoglobin value) / number of days between each visit * 14. A positive value indicates a rate of rise and a negative value indicates a rate of decline.</description>
          <population>Primary analysis set with available data at each time point</population>
          <units>g/dL/2 weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 3 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.36" spread="0.79"/>
                    <measurement group_id="O2" value="0.27" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5 (n = 89, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.81"/>
                    <measurement group_id="O2" value="0.13" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7 (n = 88, 97)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.22" spread="0.90"/>
                    <measurement group_id="O2" value="-0.19" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="0.93"/>
                    <measurement group_id="O2" value="-0.28" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11 (n = 88, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="1.01"/>
                    <measurement group_id="O2" value="0.19" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="0.93"/>
                    <measurement group_id="O2" value="-0.19" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="1.01"/>
                    <measurement group_id="O2" value="-0.01" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.22" spread="1.08"/>
                    <measurement group_id="O2" value="0.02" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 19 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.97"/>
                    <measurement group_id="O2" value="-0.06" spread="1.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 21 (n = 87, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.74"/>
                    <measurement group_id="O2" value="-0.06" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 23 (n = 88, 98)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="0.87"/>
                    <measurement group_id="O2" value="0.09" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25 (n = 87, 98)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.78"/>
                    <measurement group_id="O2" value="-0.06" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 27 (n = 88, 94)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="0.77"/>
                    <measurement group_id="O2" value="0.01" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 29 (n =89, 92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.86"/>
                    <measurement group_id="O2" value="0.05" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 31 (n = 85, 89)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.72"/>
                    <measurement group_id="O2" value="-0.03" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 33 (n = 86, 90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.16" spread="0.82"/>
                    <measurement group_id="O2" value="0.06" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 35 (n = 87, 88)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="0.98"/>
                    <measurement group_id="O2" value="-0.13" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 37 (n = 87, 93)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="1.00"/>
                    <measurement group_id="O2" value="-0.03" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemoglobin Intra-subject Variability</title>
        <description>Intra-subject variability was defined for each participant as the standard deviation (SD) of all of the hemoglobin concentrations during the evaluation period for the participant. The mean intra-subject SD for all participants is the sum of the intra-subject SDs divided by the total number of participants evaluated.</description>
        <time_frame>The evaluation period (weeks 13 to 37)</time_frame>
        <population>Primary analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Epoetin Alfa Alternative Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.</description>
          </group>
          <group group_id="O2">
            <title>Epoetin Alfa USPI Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Hemoglobin Intra-subject Variability</title>
          <description>Intra-subject variability was defined for each participant as the standard deviation (SD) of all of the hemoglobin concentrations during the evaluation period for the participant. The mean intra-subject SD for all participants is the sum of the intra-subject SDs divided by the total number of participants evaluated.</description>
          <population>Primary analysis set</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.74" spread="0.30"/>
                    <measurement group_id="O2" value="0.70" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Hemoglobin Excursions at Each Visit</title>
        <description>An excursion is identified as an event when a hemoglobin concentration fell below or exceeded the pre-specified thresholds of: - &lt; 9.0 g/dL, or - &gt; 11.0 g/dL, or - &gt; 12.0 g/dL. The percentage of participants with any excursions and excursions in each subcategory at each time point and overall during the study are reported.</description>
        <time_frame>Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37</time_frame>
        <population>Primary analysis set with available data at each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Epoetin Alfa Alternative Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.</description>
          </group>
          <group group_id="O2">
            <title>Epoetin Alfa USPI Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Hemoglobin Excursions at Each Visit</title>
          <description>An excursion is identified as an event when a hemoglobin concentration fell below or exceeded the pre-specified thresholds of: - &lt; 9.0 g/dL, or - &gt; 11.0 g/dL, or - &gt; 12.0 g/dL. The percentage of participants with any excursions and excursions in each subcategory at each time point and overall during the study are reported.</description>
          <population>Primary analysis set with available data at each time point</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall Excursions (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.0"/>
                    <measurement group_id="O2" value="93.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Excursions &lt; 9.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.3"/>
                    <measurement group_id="O2" value="61.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Excursions &gt; 11.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.9"/>
                    <measurement group_id="O2" value="83.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Excursions &gt; 12.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.8"/>
                    <measurement group_id="O2" value="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Excursions (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Excursions &lt; 9.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Excursions &gt; 11.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Excursions &gt; 12.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 Excursions (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.2"/>
                    <measurement group_id="O2" value="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 Excursions &lt; 9.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2"/>
                    <measurement group_id="O2" value="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 Excursions &gt; 11.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0"/>
                    <measurement group_id="O2" value="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 Excursions &gt; 12.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6"/>
                    <measurement group_id="O2" value="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5 Excursions (n = 89, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.0"/>
                    <measurement group_id="O2" value="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5 Excursions &lt; 9.0 (n = 89, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1"/>
                    <measurement group_id="O2" value="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5 Excursions &gt; 11.0 (n = 89, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.8"/>
                    <measurement group_id="O2" value="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5 Excursions &gt; 12.0 (n = 89, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6"/>
                    <measurement group_id="O2" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7 Excursions (n = 88, 97)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3"/>
                    <measurement group_id="O2" value="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7 Excursions &lt; 9.0 (n = 88, 97)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8"/>
                    <measurement group_id="O2" value="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7 Excursions &gt; 11.0 (n = 88, 97)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.5"/>
                    <measurement group_id="O2" value="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7 Excursions &gt; 12.0 (n = 88, 97)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 Excursions (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.2"/>
                    <measurement group_id="O2" value="17.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 Excursions &lt; 9.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0"/>
                    <measurement group_id="O2" value="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 Excursions &gt; 11.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2"/>
                    <measurement group_id="O2" value="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 Excursions &gt; 12.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11 Excursions (n = 88, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.7"/>
                    <measurement group_id="O2" value="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11 Excursions &lt; 9.0 (n = 88, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                    <measurement group_id="O2" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11 Excursions &gt; 11.0 (n = 88, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2"/>
                    <measurement group_id="O2" value="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11 Excursions &gt; 12.0 (n = 88, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13 Excursions (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.8"/>
                    <measurement group_id="O2" value="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13 Excursions &lt; 9.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9"/>
                    <measurement group_id="O2" value="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13 Excursions &gt; 11.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.0"/>
                    <measurement group_id="O2" value="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13 Excursions &gt; 12.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15 Excursions (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0"/>
                    <measurement group_id="O2" value="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15 Excursions &lt; 9.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6"/>
                    <measurement group_id="O2" value="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15 Excursions &gt; 11.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3"/>
                    <measurement group_id="O2" value="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15 Excursions &gt; 12.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17 Excursions (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.6"/>
                    <measurement group_id="O2" value="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17 Excursions &lt; 9.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0"/>
                    <measurement group_id="O2" value="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17 Excursions &gt; 11.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6"/>
                    <measurement group_id="O2" value="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17 Excursions &gt; 12.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                    <measurement group_id="O2" value="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 19 Excursions (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.1"/>
                    <measurement group_id="O2" value="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 19 Excursions &lt; 9.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0"/>
                    <measurement group_id="O2" value="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 19 Excursions &gt; 11.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1"/>
                    <measurement group_id="O2" value="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 19 Excursions &gt; 12.0 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 21 Excursions (n = 87, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.6"/>
                    <measurement group_id="O2" value="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 21 Excursions &lt; 9.0 (n = 87, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0"/>
                    <measurement group_id="O2" value="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 21 Excursions &gt; 11.0 (n = 87, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.5"/>
                    <measurement group_id="O2" value="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 21 Excursions &gt; 12.0 (n = 87, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 23 Excursions (n = 88, 98)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.5"/>
                    <measurement group_id="O2" value="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 23 Excursions &lt; 9.0 (n = 88, 98)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8"/>
                    <measurement group_id="O2" value="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 23 Excursions &gt; 11.0 (n = 88, 98)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.7"/>
                    <measurement group_id="O2" value="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 23 Excursions &gt; 12.0 (n = 88, 98)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25 Excursions (n = 87, 98)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.7"/>
                    <measurement group_id="O2" value="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25 Excursions &lt; 9.0 (n = 87, 98)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25 Excursions &gt; 11.0 (n = 87, 98)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.4"/>
                    <measurement group_id="O2" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25 Excursions &gt; 12.0 (n = 87, 98)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7"/>
                    <measurement group_id="O2" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 27 Excursions (n = 88, 94)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.5"/>
                    <measurement group_id="O2" value="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 27 Excursions &lt; 9.0 (n = 88, 94)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2"/>
                    <measurement group_id="O2" value="16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 27 Excursions &gt; 11.0 (n = 88, 94)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.3"/>
                    <measurement group_id="O2" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 27 Excursions &gt; 12.0 (n = 88, 94)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 29 Excursions (n = 89, 92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.8"/>
                    <measurement group_id="O2" value="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 29 Excursions &lt; 9.0 (n = 89, 92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6"/>
                    <measurement group_id="O2" value="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 29 Excursions &gt; 11.0 (n = 89, 92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2"/>
                    <measurement group_id="O2" value="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 29 Excursions &gt; 12.0 (n = 89, 92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                    <measurement group_id="O2" value="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 31 Excursions (n = 85, 89)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0"/>
                    <measurement group_id="O2" value="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 31 Excursions &lt; 9.0 (n = 85, 89)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7"/>
                    <measurement group_id="O2" value="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 31 Excursions &gt; 11.0 (n = 85, 89)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.3"/>
                    <measurement group_id="O2" value="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 31 Excursions &gt; 12.0 (n = 85, 89)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9"/>
                    <measurement group_id="O2" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 33 Excursions (n = 86, 90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.1"/>
                    <measurement group_id="O2" value="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 33 Excursions &lt; 9.0 (n = 86, 90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0"/>
                    <measurement group_id="O2" value="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 33 Excursions &gt; 11.0 (n = 86, 90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1"/>
                    <measurement group_id="O2" value="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 33 Excursions &gt; 12.0 (n = 86, 90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5"/>
                    <measurement group_id="O2" value="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 35 Excursions (n = 87, 88)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.4"/>
                    <measurement group_id="O2" value="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 35 Excursions &lt; 9.0 (n = 87, 88)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5"/>
                    <measurement group_id="O2" value="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 35 Excursions &gt; 11.0 (n = 87, 88)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9"/>
                    <measurement group_id="O2" value="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 35 Excursions &gt; 12.0 (n = 87, 88)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 37 Excursions (n = 87, 93)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7"/>
                    <measurement group_id="O2" value="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 37 Excursions &lt; 9.0 (n = 87, 93)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0"/>
                    <measurement group_id="O2" value="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 37 Excursions &gt; 11.0 (n = 87, 93)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6"/>
                    <measurement group_id="O2" value="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 37 Excursions &gt; 12.0 (n = 87, 93)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weekly Epoetin Alfa Dose at Each Visit</title>
        <time_frame>Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35</time_frame>
        <population>Primary analysis set with available data at each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Epoetin Alfa Alternative Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.</description>
          </group>
          <group group_id="O2">
            <title>Epoetin Alfa USPI Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Weekly Epoetin Alfa Dose at Each Visit</title>
          <population>Primary analysis set with available data at each time point</population>
          <units>units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13139.9" spread="9360.1"/>
                    <measurement group_id="O2" value="10400" spread="8439.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9683.7" spread="9162.9"/>
                    <measurement group_id="O2" value="6912.5" spread="7459.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8324.2" spread="8689.7"/>
                    <measurement group_id="O2" value="6874.0" spread="8204.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9319.1" spread="7977.5"/>
                    <measurement group_id="O2" value="6411.0" spread="7040.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9253.4" spread="8536.9"/>
                    <measurement group_id="O2" value="8003.0" spread="7292.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10039.3" spread="9194.1"/>
                    <measurement group_id="O2" value="6483.0" spread="6854.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10358.4" spread="10247.7"/>
                    <measurement group_id="O2" value="7387.5" spread="7271.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8889.3" spread="8316.8"/>
                    <measurement group_id="O2" value="6874.5" spread="5952.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10251.7" spread="9973.7"/>
                    <measurement group_id="O2" value="6924.5" spread="6211.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 19 (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10475.8" spread="10437.0"/>
                    <measurement group_id="O2" value="7112.5" spread="6300.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 21 (n = 89, 99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9605.1" spread="8225.0"/>
                    <measurement group_id="O2" value="6909.6" spread="6102.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 23 (n = 89, 98)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8905.1" spread="7748.3"/>
                    <measurement group_id="O2" value="6830.1" spread="6397.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25 (n = 89, 98)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7543.8" spread="7225.1"/>
                    <measurement group_id="O2" value="7486.7" spread="6676.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 27 (n = 89, 96)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9765.7" spread="12013.7"/>
                    <measurement group_id="O2" value="6662.5" spread="6362.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 29 (n =89, 94)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9088.8" spread="10146.9"/>
                    <measurement group_id="O2" value="6083.0" spread="6149.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 31 (n = 88, 91)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8543.2" spread="10821.7"/>
                    <measurement group_id="O2" value="6673.1" spread="6277.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 33 (n = 87, 90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9019.0" spread="10466.9"/>
                    <measurement group_id="O2" value="6235.6" spread="6041.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 35 (n = 87, 90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8709.2" spread="8631.9"/>
                    <measurement group_id="O2" value="5950.6" spread="5364.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of RBC Units Transfused Overall and During Each Study Period</title>
        <description>The number of red blood cell (RBC) units transfused during the study and during each study period.</description>
        <time_frame>Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41</time_frame>
        <population>Primary analysis set with available data in each study period</population>
        <group_list>
          <group group_id="O1">
            <title>Epoetin Alfa Alternative Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.</description>
          </group>
          <group group_id="O2">
            <title>Epoetin Alfa USPI Titration</title>
            <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of RBC Units Transfused Overall and During Each Study Period</title>
          <description>The number of red blood cell (RBC) units transfused during the study and during each study period.</description>
          <population>Primary analysis set with available data in each study period</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall Study: 1 RBC Unit (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Study: 2 RBC Units (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Study: 3 RBC Units (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Study: &gt; 3 RBC Units (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Titration Period: 1 RBC Unit (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Titration Period: 2 RBC Units (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Titration Period: 3 RBC Units (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Titration Period: &gt; 3 RBC Units (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Evaluation Period: 1 RBC Unit (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Evaluation Period: 2 RBC Units (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Evaluation Period: 3 RBC Units (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Evaluation Period: &gt; 3 RBC Units (n = 89, 100)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Safety Follow-up Period: 1 RBC Unit (n = 83, 90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Safety Follow-up Period: 2 RBC Units (n = 83, 90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Safety Follow-up Period: 3 RBC Units (n = 83, 90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Safety Follow-up Period: &gt;3 RBC Units (n = 83, 90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>41 Weeks</time_frame>
      <desc>Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.</desc>
      <group_list>
        <group group_id="E1">
          <title>Epoetin Alfa Alternative Titration</title>
          <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.</description>
        </group>
        <group group_id="E2">
          <title>Epoetin Alfa USPI Titration</title>
          <description>Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Immune thrombocytopenic purpura</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </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="107"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Cardiac valve disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperparathyroidism secondary</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Diabetic gastroparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>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="107"/>
              </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="107"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>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="107"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Vascular stent restenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Haemorrhagic hepatic cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Cystitis escherichia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hepatitis C</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Infected skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Scrotal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Sepsis syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Graft haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Bone disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Joint instability</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastatic neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hemiplegia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </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="107"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <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="107"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Bronchitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </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="3" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>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="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Steal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Superior vena cava syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Haemoglobin increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="104"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Amgen Inc.</organization>
      <phone>866-572-6436</phone>
    </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/NCT02253654
org study id: 20110208
nct id: NCT02253654
lead sponsor: 
has dmc: No
The purpose of this study is to compare two different dosing methods of epoetin alfa and
      their effectiveness in maintaining hemoglobin levels between 10.0 to 11.0 g/dL in in patients
      with chronic kidney disease (CKD) receiving hemodialysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period
time frame: The evaluation period (weeks 13-37)
description: Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant.
measure: Hemoglobin Concentration at Each Visit
time frame: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
measure: Percentage of Participants With Transfusion Events Overall and During Each Study Period
time frame: Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41
description: The percentage of participants who received red blood cell (RBC) transfusions during the study and during each study period.
measure: Hemoglobin Rate of Change at Each Visit
time frame: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
description: Hemoglobin rate of change (ROC) was calculated for each visit using the following formula: ROC = (current visit hemoglobin value - previous visit hemoglobin value) / number of days between each visit * 14. A positive value indicates a rate of rise and a negative value indicates a rate of decline.
measure: Hemoglobin Intra-subject Variability
time frame: The evaluation period (weeks 13 to 37)
description: Intra-subject variability was defined for each participant as the standard deviation (SD) of all of the hemoglobin concentrations during the evaluation period for the participant. The mean intra-subject SD for all participants is the sum of the intra-subject SDs divided by the total number of participants evaluated.
measure: Percentage of Participants With Hemoglobin Excursions at Each Visit
time frame: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
description: An excursion is identified as an event when a hemoglobin concentration fell below or exceeded the pre-specified thresholds of: - < 9.0 g/dL, or - > 11.0 g/dL, or - > 12.0 g/dL. The percentage of participants with any excursions and excursions in each subcategory at each time point and overall during the study are reported.
measure: Weekly Epoetin Alfa Dose at Each Visit
time frame: Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
measure: Number of RBC Units Transfused Overall and During Each Study Period
time frame: Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41
description: The number of red blood cell (RBC) units transfused during the study and during each study period.
arm group label: Epoetin alfa Alternative Titration
arm group type: Experimental
description: Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
arm group label: Epoetin alfa USPI Titration
arm group type: Active Comparator
description: Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
intervention type: Drug
intervention name: Epoetin alfa
description: Administered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.
arm group label: Epoetin alfa Alternative Titration
arm group label: Epoetin alfa USPI Titration
other name: Epogen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Puerto Rico
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Renal Insufficiency
mesh term: Epoetin Alfa
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 