<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/NCT01677767</url>
  </required_header>
  <id_info>
    <org_study_id>ML25475</org_study_id>
    <nct_id>NCT01677767</nct_id>
  </id_info>
  <brief_title>An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia</brief_title>
  <official_title>Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients 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 chronic kidney disease patients on dialysis&#xD;
      receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be&#xD;
      followed for 24 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2011</start_date>
  <completion_date type="Actual">September 30, 2013</completion_date>
  <primary_completion_date type="Actual">September 30, 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 Age of Participants Treated With C.E.R.A</measure>
    <time_frame>Baseline (Week 0)</time_frame>
    <description>Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Weight of Participants Treated With C.E.R.A</measure>
    <time_frame>Baseline (Week 0)</time_frame>
    <description>Weight of the participants was measured at the Baseline and summarized with descriptive statistics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Co-morbidity Treated With C.E.R.A</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Time Required to Achieve Target Hemoglobin Range</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieved Target Range of Hemoglobin</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb &lt; 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Time Spent by Participants in the Hb Target Range</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Route of Administration for C.E.R.A</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Dose Per Injection of C.E.R.A</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Received Concomitant Medications</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">127</enrollment>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic kidney disease on dialysis receiving treatment with Mircera for&#xD;
        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 chronic kidney disease on dialysis&#xD;
&#xD;
          -  ESA naïve with Hb &lt; 10 g/dL, or on treatment with ESAs other than Mircera and Hb&#xD;
             within the target range of 10-12 g/dL&#xD;
&#xD;
          -  Adequate irons 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>
      <name>Sir Gangaram Hospital</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ahmedabad Dialysis Centre</name>
      <address>
        <city>Ahmedabad</city>
        <zip>380005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Excel Center</name>
      <address>
        <city>Guwahati</city>
        <zip>781007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ESIS Hospital; Department of Nephrology</name>
      <address>
        <city>Kolkata</city>
        <zip>600054</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vertex Hospital</name>
      <address>
        <city>Mumbai</city>
        <zip>400083</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apollo Indraprastha Hospitals; Nephrology</name>
      <address>
        <city>New Delhi</city>
        <zip>110076</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aditya Birla Memorial Hospital</name>
      <address>
        <city>Pune</city>
        <zip>411033</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <results_first_submitted>January 6, 2016</results_first_submitted>
  <results_first_submitted_qc>January 6, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 5, 2016</results_first_posted>
  <last_update_submitted>June 13, 2017</last_update_submitted>
  <last_update_submitted_qc>June 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2017</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 127 participants were enrolled from 7 centers in India. This study was conducted between 14 April 2011 and 23 September 2013.</recruitment_details>
      <pre_assignment_details>Out of 127 participants enrolled in the study, 1 participant was enrolled wrongly and data for 2 participants were not available at the study Centre. Therefore, 124 participants were evaluated in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>C.E.R.A.</title>
          <description>Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="124"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </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>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance by the participants</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>Intention-to-Treat (ITT) population included all the participants who received at least 1 dose of C.E.R.A and for whom data for at least one follow-up variable was available</population>
      <group_list>
        <group group_id="B1">
          <title>C.E.R.A.</title>
          <description>Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="124"/>
          </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="48.1" spread="12.26"/>
                  </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="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <description>For mean height of participants n = 112 as height of some participants was not captured.</description>
          <units>Centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="157.83" spread="10.056"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Age of Participants Treated With C.E.R.A</title>
        <description>Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25</description>
        <time_frame>Baseline (Week 0)</time_frame>
        <population>The safety population included all participants enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Age of Participants Treated With C.E.R.A</title>
          <description>Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25</description>
          <population>The safety population included all participants enrolled into the study.</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.1" spread="12.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Weight of Participants Treated With C.E.R.A</title>
        <description>Weight of the participants was measured at the Baseline and summarized with descriptive statistics.</description>
        <time_frame>Baseline (Week 0)</time_frame>
        <population>The safety population included all participants enrolled into the study. The analysis population reflects those participants whose weights were assessed at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Weight of Participants Treated With C.E.R.A</title>
          <description>Weight of the participants was measured at the Baseline and summarized with descriptive statistics.</description>
          <population>The safety population included all participants enrolled into the study. The analysis population reflects those participants whose weights were assessed at baseline.</population>
          <units>Kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.44" spread="13.269"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Co-morbidity Treated With C.E.R.A</title>
        <description>Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The safety population included all participants enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Co-morbidity Treated With C.E.R.A</title>
          <description>Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.</description>
          <population>The safety population included all participants enrolled into the study.</population>
          <units>Number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total comorbid participants</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Comorbidity, renal and urinary disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Comorbidity, vascular disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Comorbidity, metabolism and nutrition disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Time Required to Achieve Target Hemoglobin Range</title>
        <description>The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1</description>
        <time_frame>Up to Week 24</time_frame>
        <population>ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (&lt;) 10 g/dL at enrollment.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with Hb less than (&lt;) 10 g/dL at enrollment were evaluated for correction of anemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Time Required to Achieve Target Hemoglobin Range</title>
          <description>The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1</description>
          <population>ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (&lt;) 10 g/dL at enrollment.</population>
          <units>Week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.66" spread="5.652"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieved Target Range of Hemoglobin</title>
        <description>The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb &lt; 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (&lt;) 10 g/dL at enrollment.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with Hb less than (&lt;) 10 g/dL at enrollment were evaluated for correction of anemia.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieved Target Range of Hemoglobin</title>
          <description>The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb &lt; 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.</description>
          <population>ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (&lt;) 10 g/dL at enrollment.</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="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study</title>
        <description>For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study</title>
          <description>For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.</description>
          <population>ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.</population>
          <units>Number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Time Spent by Participants in the Hb Target Range</title>
        <description>Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>ITT population included the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Time Spent by Participants in the Hb Target Range</title>
          <description>Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.</description>
          <population>ITT population included the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.</population>
          <units>Week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.54" spread="6.143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Route of Administration for C.E.R.A</title>
        <description>C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The safety population included all participants enrolled into the study</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Route of Administration for C.E.R.A</title>
          <description>C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.</description>
          <population>The safety population included all participants enrolled into the study</population>
          <units>Number of injections</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Intravenous administration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subcutaneous administration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="647"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Dose Per Injection of C.E.R.A</title>
        <description>The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The safety population included all participants enrolled into the study</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Dose Per Injection of C.E.R.A</title>
          <description>The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.</description>
          <population>The safety population included all participants enrolled into the study</population>
          <units>Microgram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.0" spread="21.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Received Concomitant Medications</title>
        <description>Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The safety population included all participants enrolled into the study</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Received Concomitant Medications</title>
          <description>Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.</description>
          <population>The safety population included all participants enrolled into the study</population>
          <units>Number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.</title>
        <description>Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>C.E.R.A.</title>
            <description>Participants with chronic renal anemia who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.</title>
          <description>Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.</description>
          <population>ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.</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="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 24</time_frame>
      <desc>An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.</desc>
      <group_list>
        <group group_id="E1">
          <title>C.E.R.A.</title>
          <description>Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <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="6" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <description>General Disorders And Administrations</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <description>General Disorders And Administrations</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic renal failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="124"/>
              </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="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <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="21" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <description>General Disorders And Administrations</description>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <description>General Disorders And Administrations</description>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="124"/>
              </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 616878333</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/NCT01677767
org study id: ML25475
nct id: NCT01677767
lead sponsor: 
This observational study will evaluate the use in clinical practice and efficacy of Mircera
      (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients 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 Age of Participants Treated With C.E.R.A
time frame: Baseline (Week 0)
description: Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25
measure: Mean Weight of Participants Treated With C.E.R.A
time frame: Baseline (Week 0)
description: Weight of the participants was measured at the Baseline and summarized with descriptive statistics.
measure: Number of Participants With Co-morbidity Treated With C.E.R.A
time frame: Up to Week 24
description: Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.
measure: Mean Time Required to Achieve Target Hemoglobin Range
time frame: Up to Week 24
description: The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1
measure: Percentage of Participants Achieved Target Range of Hemoglobin
time frame: Up to Week 24
description: The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.
measure: Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.
time frame: Up to Week 24
description: Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.
measure: Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study
time frame: Up to Week 24
description: For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.
measure: Mean Time Spent by Participants in the Hb Target Range
time frame: Up to Week 24
description: Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.
measure: Evaluation of Route of Administration for C.E.R.A
time frame: Up to Week 24
description: C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.
measure: Evaluation of Dose Per Injection of C.E.R.A
time frame: Up to Week 24
description: The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.
measure: Number of Participants Received Concomitant Medications
time frame: Up to Week 24
description: Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.
arm group label: Cohort
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: 
facility: 
country: India
responsible party type: Sponsor
mesh term: Anemia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 