<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/NCT02238080</url>
  </required_header>
  <id_info>
    <org_study_id>ML22556</org_study_id>
    <nct_id>NCT02238080</nct_id>
  </id_info>
  <brief_title>An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis</brief_title>
  <acronym>IMPACT</acronym>
  <official_title>Inflammatory Markers and Mircera® Prospective Assessment of Correlation (IMPACT): A Multi-Center Observational Study Investigating the Correlation Between Inflammatory Marker Levels and ESA Dosage in CKD Patients on Dialysis Treated With Mircera®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational, multi-center, open-label, prospective study will evaluate the&#xD;
      relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and&#xD;
      methoxy polyethylene glycol-epoetin beta dosage in participants with chronic kidney disease&#xD;
      (CKD) on dialysis. Participants will be recruited who are on stable methoxy polyethylene&#xD;
      glycol-epoetin beta maintenance therapy or will initiate therapy with methoxy polyethylene&#xD;
      glycol-epoetin beta.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2009</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose</measure>
    <time_frame>Day 1</time_frame>
    <description>Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose</measure>
    <time_frame>Day 1</time_frame>
    <description>Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than [&gt;] 200 micrograms per kilogram [mcg/kg]), and (c) Dose decrease (1 to &gt;200 mcg/kg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6</measure>
    <time_frame>Baseline, Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum CRP Level</measure>
    <time_frame>Baseline, Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum IL-6 Level</measure>
    <time_frame>Baseline, Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Hemoglobin Level</measure>
    <time_frame>Baseline, Month 6</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">197</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>Methoxy Polyethylene Glycol-Epoetin Beta</arm_group_label>
    <description>Participants with anemia and CKD who are on dialysis therapy, and who initiate erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta or who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, will be treated according to the usual standard of care and current best practice guidelines, and will be observed during the study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methoxy Polyethylene Glycol-Epoetin Beta</intervention_name>
    <description>Methoxy polyethylene glycol-epoetin beta will be administered according to the usual standard of care and current best practice guidelines and will be observed during the study period.</description>
    <arm_group_label>Methoxy Polyethylene Glycol-Epoetin Beta</arm_group_label>
    <other_name>Mircera®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult participants with CKD on dialysis therapy, either initiating ESA treatment with&#xD;
        methoxy polyethylene glycol-epoetin beta or on stable methoxy polyethylene glycol-epoetin&#xD;
        beta maintenance therapy. The study is to be conducted in Israel.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CKD participants undergoing dialysis&#xD;
&#xD;
          -  Participants initiating ESA treatment with methoxy polyethylene glycol-epoetin beta or&#xD;
             participants on stable methoxy polyethylene glycol-epoetin beta maintenance therapy&#xD;
&#xD;
          -  Adequate iron status defined as: serum ferritin above or equal to 100 micrograms per&#xD;
             liter (mcg/L) or transferrin saturation above or equal to 20 percent (%)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Conditions known to cause inadequate response to ESA treatment&#xD;
&#xD;
          -  Anemia other than symptomatic anemia associated with CKD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haemek Hospital; Nephrology</name>
      <address>
        <city>Afula</city>
        <zip>18101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barzilai Medical Centre ; Nephrology and Hypertension</name>
      <address>
        <city>Ashkelon</city>
        <zip>78306</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka Medical Center; Nephrology</name>
      <address>
        <city>Beer Sheva</city>
        <zip>84101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bnai Zion MC; Nephrology</name>
      <address>
        <city>Haifa</city>
        <zip>31048</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carmel Medical Center; Nephrology</name>
      <address>
        <city>Haifa</city>
        <zip>34362</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wolfson MC; Nephrology</name>
      <address>
        <city>Holon</city>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center; Nrphrology Dept.</name>
      <address>
        <city>Jerusalem</city>
        <zip>91031</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Orgainastion; Nephrology</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center; Nephrology Dept.</name>
      <address>
        <city>Kfar Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Galilee Hospital; Nrphrology Dept.</name>
      <address>
        <city>Nahariya</city>
        <zip>22100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EMMS Nazareth; Nephrology</name>
      <address>
        <city>Nazareth</city>
        <zip>16100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Family Hospital; Nephrology</name>
      <address>
        <city>Nazareth</city>
        <zip>16100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beilinson Medical Center; Nephrology</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba MC; Nephrology</name>
      <address>
        <city>Ramat-Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rebecca Sief Hospital; Nephrology</name>
      <address>
        <city>Safed</city>
        <zip>13100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sourasky MC; Dept. of Nephrology</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poria Hospital; Nephrology</name>
      <address>
        <city>Tiberias</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assaf-Harofeh MC; Nephrology</name>
      <address>
        <city>Zrifin</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>February 20, 2017</results_first_submitted>
  <results_first_submitted_qc>February 20, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 6, 2017</results_first_posted>
  <last_update_submitted>April 10, 2017</last_update_submitted>
  <last_update_submitted_qc>April 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 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>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Methoxy Polyethylene Glycol-Epoetin Beta</title>
          <description>Participants with anemia and chronic kidney disease (CKD) who were on dialysis therapy, and who initiated erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta (Mircera) or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="197"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Treatment interrupted</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intention-to-Treat (ITT) population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Methoxy Polyethylene Glycol-Epoetin Beta</title>
          <description>Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="197"/>
          </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="66.7" spread="12.3"/>
                  </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="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose</title>
        <description>Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).</description>
        <time_frame>Day 1</time_frame>
        <population>ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Methoxy Polyethylene Glycol-Epoetin Beta</title>
            <description>Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose</title>
          <description>Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).</description>
          <population>ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1485"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose</title>
        <description>Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).</description>
        <time_frame>Day 1</time_frame>
        <population>ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Methoxy Polyethylene Glycol-Epoetin Beta</title>
            <description>Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose</title>
          <description>Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).</description>
          <population>ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05557"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6</title>
        <description>Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than [&gt;] 200 micrograms per kilogram [mcg/kg]), and (c) Dose decrease (1 to &gt;200 mcg/kg).</description>
        <time_frame>Month 6</time_frame>
        <population>ITT population. Participants with stable maintenance treatment were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Methoxy Polyethylene Glycol-Epoetin Beta</title>
            <description>Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6</title>
          <description>Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than [&gt;] 200 micrograms per kilogram [mcg/kg]), and (c) Dose decrease (1 to &gt;200 mcg/kg).</description>
          <population>ITT population. Participants with stable maintenance treatment were included in this analysis.</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="189"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose decrease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6</title>
        <time_frame>Baseline, Month 6</time_frame>
        <population>ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure. 'Number analyzed' included participants evaluable for individual categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Methoxy Polyethylene Glycol-Epoetin Beta</title>
            <description>Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6</title>
          <population>ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure. 'Number analyzed' included participants evaluable for individual categories.</population>
          <units>mcg/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="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="175.2" spread="109.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6" spread="100.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum CRP Level</title>
        <time_frame>Baseline, Month 6</time_frame>
        <population>ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Methoxy Polyethylene Glycol-Epoetin Beta</title>
            <description>Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum CRP Level</title>
          <population>ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories.</population>
          <units>milligrams per liter (mg/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="189"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.7" spread="18.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3" spread="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum IL-6 Level</title>
        <time_frame>Baseline, Month 6</time_frame>
        <population>ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Methoxy Polyethylene Glycol-Epoetin Beta</title>
            <description>Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum IL-6 Level</title>
          <population>ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories.</population>
          <units>picograms per milliliter (pg/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="189"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" spread="18.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6</title>
        <description>Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).</description>
        <time_frame>Month 6</time_frame>
        <population>ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Methoxy Polyethylene Glycol-Epoetin Beta</title>
            <description>Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6</title>
          <description>Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).</description>
          <population>ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12684"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6</title>
        <description>Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).</description>
        <time_frame>Month 6</time_frame>
        <population>ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Methoxy Polyethylene Glycol-Epoetin Beta</title>
            <description>Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6</title>
          <description>Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).</description>
          <population>ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19473"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose</title>
        <time_frame>Day 1</time_frame>
        <population>As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Methoxy Polyethylene Glycol-Epoetin Beta</title>
            <description>Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.</description>
          </group>
        </group_list>
        <measure>
          <title>Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose</title>
          <population>As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome.</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>Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose</title>
        <time_frame>Day 1</time_frame>
        <population>As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Methoxy Polyethylene Glycol-Epoetin Beta</title>
            <description>Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.</description>
          </group>
        </group_list>
        <measure>
          <title>Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose</title>
          <population>As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome.</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>Serum Hemoglobin Level</title>
        <time_frame>Baseline, Month 6</time_frame>
        <population>ITT population. 'Number analyzed' included participants evaluable for individual categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Methoxy Polyethylene Glycol-Epoetin Beta</title>
            <description>Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Hemoglobin Level</title>
          <population>ITT population. 'Number analyzed' included participants evaluable for individual categories.</population>
          <units>grams per deciliter (g/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 6 months</time_frame>
      <desc>Safety population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta after enrollment in the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Methoxy Polyethylene Glycol-Epoetin Beta</title>
          <description>Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 19.1</default_vocab>
        <default_assessment>Non-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="48" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous graft site infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Bacteremia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Localized infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Peritonitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Laryngeal cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Hemiplegia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Hepatic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Ischemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Transient ischemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Leg amputation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Femoral artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Microscopic polyangiitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA Version 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Breast cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Venous pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Food intolerance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </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="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula operation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Leg amputation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Toe amputation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
              </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>
    <limitations_and_caveats>The study was completed as defined in the protocol. Only 197 participants (out of planned 400) were enrolled due to slow recruitment during the study period.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.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/NCT02238080
org study id: ML22556
nct id: NCT02238080
lead sponsor: 
has dmc: No
This observational, multi-center, open-label, prospective study will evaluate the
      relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and
      methoxy polyethylene glycol-epoetin beta dosage in participants with chronic kidney disease
      (CKD) on dialysis. Participants will be recruited who are on stable methoxy polyethylene
      glycol-epoetin beta maintenance therapy or will initiate therapy with methoxy polyethylene
      glycol-epoetin beta.
observational model: Cohort
time perspective: Prospective
measure: Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose
time frame: Day 1
description: Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
measure: Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose
time frame: Day 1
description: Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
measure: Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
time frame: Month 6
description: Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than [>] 200 micrograms per kilogram [mcg/kg]), and (c) Dose decrease (1 to >200 mcg/kg).
measure: Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
time frame: Baseline, Month 6
measure: Serum CRP Level
time frame: Baseline, Month 6
measure: Serum IL-6 Level
time frame: Baseline, Month 6
measure: Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
time frame: Month 6
description: Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
measure: Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
time frame: Month 6
description: Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
measure: Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose
time frame: Day 1
measure: Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose
time frame: Day 1
measure: Serum Hemoglobin Level
time frame: Baseline, Month 6
arm group label: Methoxy Polyethylene Glycol-Epoetin Beta
description: Participants with anemia and CKD who are on dialysis therapy, and who initiate erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta or who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, will be treated according to the usual standard of care and current best practice guidelines, and will be observed during the study period.
intervention type: Drug
intervention name: Methoxy Polyethylene Glycol-Epoetin Beta
description: Methoxy polyethylene glycol-epoetin beta will be administered according to the usual standard of care and current best practice guidelines and will be observed during the study period.
arm group label: Methoxy Polyethylene Glycol-Epoetin Beta
other name: Mircera®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Israel
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Epoetin Alfa
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was completed as defined in the protocol. Only 197 participants (out of planned 400) were enrolled due to slow recruitment during the study period.
point of contact: 