<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/NCT01695746</url>
  </required_header>
  <id_info>
    <org_study_id>ML25476</org_study_id>
    <nct_id>NCT01695746</nct_id>
  </id_info>
  <brief_title>An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage III-IV Chronic Kidney Disease Patients Not on Dialysis With Renal Anemia</brief_title>
  <official_title>Efficacy of Methoxy Poly-Ethylene Glycol Epoetin Beta (C.E.R.A.) for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients in Stage III - IV, Not on Dialysis, Treated According to Routine Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This observational study will evaluate the use in clinical practice and efficacy of Mircera&#xD;
      (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic kidney disease patients&#xD;
      not on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible&#xD;
      patients will be followed for 24 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Height of Participants at Baseline (Week 0)</measure>
    <time_frame>At Baseline (Week 0)</time_frame>
    <description>The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Weight of Participants at Baseline (Week 0)</measure>
    <time_frame>At Baseline (Week 0)</time_frame>
    <description>The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Co-morbidities at Baseline (Week 0)</measure>
    <time_frame>At Baseline (Week 0)</time_frame>
    <description>Co-morbidities were those medical disorders present in the medical history but unresolved at Baseline. The number of participants with different co-morbidities is presented. Baseline is defined as Week 0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Correction of anemia was evaluated in participants with Hb &lt; 10 gram/deciliter (g/dL). Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The mean time required to achieve target Hb range (10-12 g/dL) was calculated using the following formula: Time to achieve target range = (Date of Hb evaluation when participant achieves target range at first time - visit date of first dosing) + 1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Maintenance of Hb levels was to be evaluated for participants on Erythropoiesis stimulating agent (ESA) with Hb levels 10-12 g/dL. None of the participants in the enrolled population had received treatment with other ESAs and had pre-therapy Hb level as 10 g/dL or above. Therefore, the percentage of participants who had received treatment with other ESAs and were maintaining Hb level within 1 g/dL of baseline value during the study could not be evaluated. Baseline is defined as Week 0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Correction of anemia was evaluated in participants with Hb &lt; 10 g/dL at enrollment. Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The percentage of participants achieving the target Hb range (10-12 g/dL) at least once during the study is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter)</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 24. The mean time spent (in weeks) by the participants in the target range (10 - 12 g/dL) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Dose of C.E.R.A. Administered</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>The mean dose of C.E.R.A. administered during the study is reported. This accounts for the study drug injected through subcutaneous route at a frequency of every 4 weeks or once a month and every 2 weeks or fortnightly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Doses of C.E.R.A. Administered by Different Routes</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>The number of doses of C.E.R.A. administered by the intravenous or subcutaneous route is presented. The number of doses for total population is calculated by summation and presented in table below as per routes of administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Concomitant Treatment for Anemia</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Medications that were used during the study treatment period (from the date of first dose of study medication to the end of the study) were included as concomitant medications. The number of participants taking concomitant medications prescribed for the treatment of anemia (for example iron) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events and Serious Adverse Events</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">108</enrollment>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>C.E.R.A.</arm_group_label>
    <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, will be administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) according to routine clinical practice and will be followed up for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment will be at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label are - For correction of anemia: 0.6 microgram per kilogram (mcg/kg) of C.E.R.A. once every two weeks, and for Maintenance of hemoglobin (Hb) levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>C.E.R.A.</intervention_name>
    <description>Participants receiving 0.6 mcg/kg of C.E.R.A. once every two weeks for correction of anemia and conversion to C.E.R.A. dose 120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks for maintenance of Hb according to local clinical practice or prescribing information will be observed.</description>
    <arm_group_label>C.E.R.A.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with stage III-IV chronic kidney disease not on dialysis receiving treatment with&#xD;
        Mircera for chronic renal anemia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, 18 to 65 years of age, inclusive&#xD;
&#xD;
          -  Patients with stage III-IV chronic kidney disease not on dialysis&#xD;
&#xD;
          -  Erythropoiesis stimulating agent (ESA) naïve with Hb &lt; 10 g/dL, or on treatment with&#xD;
             ESAs other than Mircera and Hb within the target range of 10-12 g/dL&#xD;
&#xD;
          -  Adequate iron status as judged by the treating physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any&#xD;
             constituent of the study medication&#xD;
&#xD;
          -  Clinically significant concomitant disease or disorder as defined by protocol&#xD;
&#xD;
          -  Clinical suspicion of pure red cell aplasia (PRCA)&#xD;
&#xD;
          -  Planned elective surgery during the study period , except for cataract surgery or&#xD;
             vascular access surgery&#xD;
&#xD;
          -  Transfusion of red blood cells in the previous 2 months&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Contraindications for Mircera according to local prescribing information or as judged&#xD;
             by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Bhubaneswar</city>
        <zip>751021</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hyderabad</city>
        <zip>500 029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mumbai</city>
        <zip>400012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mumbai</city>
        <zip>400036</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vadodara</city>
        <zip>390005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vellore</city>
        <zip>632006</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <results_first_submitted>March 8, 2016</results_first_submitted>
  <results_first_submitted_qc>April 26, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 2, 2016</results_first_posted>
  <last_update_submitted>April 26, 2016</last_update_submitted>
  <last_update_submitted_qc>April 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 108 participants were enrolled in this study conducted from 30 August 2011 to 13 November 2013 at 6 sites in India.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>C.E.R.A.</title>
          <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</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_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance by the participant</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant not willing to participate</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics were evaluated for the safety population which included all participants entered into the study.</population>
      <group_list>
        <group group_id="B1">
          <title>C.E.R.A.</title>
          <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="108"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.5" spread="7.178"/>
                  </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="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Height of Participants at Baseline (Week 0)</title>
        <description>The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.</description>
        <time_frame>At Baseline (Week 0)</time_frame>
        <population>The safety population included all participants entered into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Height of Participants at Baseline (Week 0)</title>
          <description>The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.</description>
          <population>The safety population included all participants entered into the study.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163.15" spread="7.366"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Weight of Participants at Baseline (Week 0)</title>
        <description>The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.</description>
        <time_frame>At Baseline (Week 0)</time_frame>
        <population>The safety population included all participants entered into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Weight of Participants at Baseline (Week 0)</title>
          <description>The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.</description>
          <population>The safety population included all participants entered into the study.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.23" spread="9.618"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study</title>
        <description>Correction of anemia was evaluated in participants with Hb &lt; 10 g/dL at enrollment. Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The percentage of participants achieving the target Hb range (10-12 g/dL) at least once during the study is presented.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The ITT population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study</title>
          <description>Correction of anemia was evaluated in participants with Hb &lt; 10 g/dL at enrollment. Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The percentage of participants achieving the target Hb range (10-12 g/dL) at least once during the study is presented.</description>
          <population>The ITT population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation.</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="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter)</title>
        <description>The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 24. The mean time spent (in weeks) by the participants in the target range (10 - 12 g/dL) is presented.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The ITT population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter)</title>
          <description>The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 24. The mean time spent (in weeks) by the participants in the target range (10 - 12 g/dL) is presented.</description>
          <population>The ITT population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.</population>
          <units>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="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.69" spread="4.124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Dose of C.E.R.A. Administered</title>
        <description>The mean dose of C.E.R.A. administered during the study is reported. This accounts for the study drug injected through subcutaneous route at a frequency of every 4 weeks or once a month and every 2 weeks or fortnightly.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The safety population included all participants entered into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Dose of C.E.R.A. Administered</title>
          <description>The mean dose of C.E.R.A. administered during the study is reported. This accounts for the study drug injected through subcutaneous route at a frequency of every 4 weeks or once a month and every 2 weeks or fortnightly.</description>
          <population>The safety population included all participants entered into the study.</population>
          <units>mcg per month</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.5" spread="26.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Doses of C.E.R.A. Administered by Different Routes</title>
        <description>The number of doses of C.E.R.A. administered by the intravenous or subcutaneous route is presented. The number of doses for total population is calculated by summation and presented in table below as per routes of administration.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The safety population included all participants entered into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Doses of C.E.R.A. Administered by Different Routes</title>
          <description>The number of doses of C.E.R.A. administered by the intravenous or subcutaneous route is presented. The number of doses for total population is calculated by summation and presented in table below as per routes of administration.</description>
          <population>The safety population included all participants entered into the study.</population>
          <units>Doses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Intravenous route</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subcutaneous route</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="572"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Co-morbidities at Baseline (Week 0)</title>
        <description>Co-morbidities were those medical disorders present in the medical history but unresolved at Baseline. The number of participants with different co-morbidities is presented. Baseline is defined as Week 0.</description>
        <time_frame>At Baseline (Week 0)</time_frame>
        <population>The safety population included all participants entered into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A (Continuous Erythropoietin Receptor Activator)</title>
            <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, receiving therapy with C.E.R.A. according to routine clinical practice were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 μg/kg of C.E.R.A once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 μg either once monthly; or 60, 100, or 180 μg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Co-morbidities at Baseline (Week 0)</title>
          <description>Co-morbidities were those medical disorders present in the medical history but unresolved at Baseline. The number of participants with different co-morbidities is presented. Baseline is defined as Week 0.</description>
          <population>The safety population included all participants entered into the study.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myocardial ischaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Congenital cystic kidney disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal hypoplasia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypothyroidism</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Liver disorder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes mellitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyslipidaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 1 diabetes mellitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 2 diabetes mellitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Osteoarthritis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Osteoporosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rheumatoid arthritis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systemic lupus erythematosus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glomerulonephritis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nephrolithiasis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nephropathy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal failure chronic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tubulointerstitial nephritis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chronic obstructive pulmonary disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coronary angioplasty</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal transplant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)</title>
        <description>Correction of anemia was evaluated in participants with Hb &lt; 10 gram/deciliter (g/dL). Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The mean time required to achieve target Hb range (10-12 g/dL) was calculated using the following formula: Time to achieve target range = (Date of Hb evaluation when participant achieves target range at first time - visit date of first dosing) + 1.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The intent-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)</title>
          <description>Correction of anemia was evaluated in participants with Hb &lt; 10 gram/deciliter (g/dL). Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The mean time required to achieve target Hb range (10-12 g/dL) was calculated using the following formula: Time to achieve target range = (Date of Hb evaluation when participant achieves target range at first time - visit date of first dosing) + 1.</description>
          <population>The intent-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.</population>
          <units>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="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.61" spread="6.130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value</title>
        <description>Maintenance of Hb levels was to be evaluated for participants on Erythropoiesis stimulating agent (ESA) with Hb levels 10-12 g/dL. None of the participants in the enrolled population had received treatment with other ESAs and had pre-therapy Hb level as 10 g/dL or above. Therefore, the percentage of participants who had received treatment with other ESAs and were maintaining Hb level within 1 g/dL of baseline value during the study could not be evaluated. Baseline is defined as Week 0.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The ITT population was the anticipated population for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value</title>
          <description>Maintenance of Hb levels was to be evaluated for participants on Erythropoiesis stimulating agent (ESA) with Hb levels 10-12 g/dL. None of the participants in the enrolled population had received treatment with other ESAs and had pre-therapy Hb level as 10 g/dL or above. Therefore, the percentage of participants who had received treatment with other ESAs and were maintaining Hb level within 1 g/dL of baseline value during the study could not be evaluated. Baseline is defined as Week 0.</description>
          <population>The ITT population was the anticipated population for analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Concomitant Treatment for Anemia</title>
        <description>Medications that were used during the study treatment period (from the date of first dose of study medication to the end of the study) were included as concomitant medications. The number of participants taking concomitant medications prescribed for the treatment of anemia (for example iron) is presented.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The safety population included all participants entered into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Concomitant Treatment for Anemia</title>
          <description>Medications that were used during the study treatment period (from the date of first dose of study medication to the end of the study) were included as concomitant medications. The number of participants taking concomitant medications prescribed for the treatment of anemia (for example iron) is presented.</description>
          <population>The safety population included all participants entered into the study.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Multivitamin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Iron supplement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vitamin B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Iron + multivitamin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events and Serious Adverse Events</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The safety population was defined as all participants entered into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events and Serious Adverse Events</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.</description>
          <population>The safety population was defined as all participants entered into the study.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of participants with any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of participants with any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 24</time_frame>
      <desc>Adverse event data was reported for the safety population which included all participants entered into the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>C.E.R.A.</title>
          <description>Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.1</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="2" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>HIV test positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="108"/>
              </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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Roche Trial Information Hotline</name_or_title>
      <organization>F. Hoffmann-La Roche AG</organization>
      <phone>+41 61 6878333</phone>
      <email>global.trial_information@roche.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01695746
org study id: ML25476
nct id: NCT01695746
lead sponsor: 
This observational study will evaluate the use in clinical practice and efficacy of Mircera
      (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic kidney disease patients
      not on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible
      patients will be followed for 24 weeks.
observational model: Cohort
time perspective: Prospective
measure: Mean Height of Participants at Baseline (Week 0)
time frame: At Baseline (Week 0)
description: The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.
measure: Mean Weight of Participants at Baseline (Week 0)
time frame: At Baseline (Week 0)
description: The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.
measure: Number of Participants With Co-morbidities at Baseline (Week 0)
time frame: At Baseline (Week 0)
description: Co-morbidities were those medical disorders present in the medical history but unresolved at Baseline. The number of participants with different co-morbidities is presented. Baseline is defined as Week 0.
measure: Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)
time frame: Up to Week 24
description: Correction of anemia was evaluated in participants with Hb < 10 gram/deciliter (g/dL). Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The mean time required to achieve target Hb range (10-12 g/dL) was calculated using the following formula: Time to achieve target range = (Date of Hb evaluation when participant achieves target range at first time - visit date of first dosing) + 1.
measure: Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value
time frame: Up to Week 24
description: Maintenance of Hb levels was to be evaluated for participants on Erythropoiesis stimulating agent (ESA) with Hb levels 10-12 g/dL. None of the participants in the enrolled population had received treatment with other ESAs and had pre-therapy Hb level as 10 g/dL or above. Therefore, the percentage of participants who had received treatment with other ESAs and were maintaining Hb level within 1 g/dL of baseline value during the study could not be evaluated. Baseline is defined as Week 0.
measure: Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study
time frame: Up to Week 24
description: Correction of anemia was evaluated in participants with Hb < 10 g/dL at enrollment. Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The percentage of participants achieving the target Hb range (10-12 g/dL) at least once during the study is presented.
measure: Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter)
time frame: Up to Week 24
description: The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 24. The mean time spent (in weeks) by the participants in the target range (10 - 12 g/dL) is presented.
measure: Mean Dose of C.E.R.A. Administered
time frame: Up to Week 24
description: The mean dose of C.E.R.A. administered during the study is reported. This accounts for the study drug injected through subcutaneous route at a frequency of every 4 weeks or once a month and every 2 weeks or fortnightly.
measure: Number of Doses of C.E.R.A. Administered by Different Routes
time frame: Up to Week 24
description: The number of doses of C.E.R.A. administered by the intravenous or subcutaneous route is presented. The number of doses for total population is calculated by summation and presented in table below as per routes of administration.
measure: Number of Participants Who Received Concomitant Treatment for Anemia
time frame: Up to Week 24
description: Medications that were used during the study treatment period (from the date of first dose of study medication to the end of the study) were included as concomitant medications. The number of participants taking concomitant medications prescribed for the treatment of anemia (for example iron) is presented.
measure: Number of Participants With Adverse Events and Serious Adverse Events
time frame: Up to Week 24
description: An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
arm group label: C.E.R.A.
description: Participants with chronic renal anemia Stage III-IV, not on dialysis, will be administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) according to routine clinical practice and will be followed up for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment will be at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label are - For correction of anemia: 0.6 microgram per kilogram (mcg/kg) of C.E.R.A. once every two weeks, and for Maintenance of hemoglobin (Hb) levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
intervention type: Drug
intervention name: C.E.R.A.
description: Participants receiving 0.6 mcg/kg of C.E.R.A. once every two weeks for correction of anemia and conversion to C.E.R.A. dose 120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks for maintenance of Hb according to local clinical practice or prescribing information will be observed.
arm group label: C.E.R.A.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: India
responsible party type: Sponsor
mesh term: Anemia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 