<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/NCT02263833</url>
  </required_header>
  <id_info>
    <org_study_id>ML22560</org_study_id>
    <nct_id>NCT02263833</nct_id>
  </id_info>
  <brief_title>An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical Practice</brief_title>
  <official_title>Post Marketing Surveillance of 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 national study was a post-marketing surveillance study conducted in Korea from 29 August&#xD;
      2008 to 28 August 2012 to meet local regulatory requirements for Mircera&#xD;
      (monopegylated-epoetin beta). Prospective participant-based data collection was evaluated for&#xD;
      safety/risk assessments and effectiveness. No specific study-related procedures are required.&#xD;
      Participants were to be followed up as long as possible at the physician's discretion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 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>Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event</measure>
    <time_frame>At physician's discretion, up to 4 years</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With an Adverse Drug Reaction (ADR)</measure>
    <time_frame>At physician's discretion, up to 4 years</time_frame>
    <description>ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as &quot;definitely related&quot;,&quot;probably related&quot;, &quot;possibly related&quot;, and &quot;unknown&quot; by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as &quot;Unexpected&quot;. An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Percentage of ESA Naïve Participants Having an Increase in Hemoglobin (Hb) Level of at Least 1 g/dL From Baseline and Reaching the Hb Level Greater Than or Equal to (&gt;/=) 11 g/dL Without Red Blood Cell Transfusion</measure>
    <time_frame>Up to 4 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants on ESA Therapy Who Were Switched to Mircera Having a Hemoglobin Concentration in the Range of 10 to 12 g/dL</measure>
    <time_frame>Up to 4 years</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">748</enrollment>
  <condition>Kidney Disease, Chronic</condition>
  <arm_group>
    <arm_group_label>Overall Participants</arm_group_label>
    <description>Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were switched to Mircera</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mircera</intervention_name>
    <description>Participants received Mircera according to individualized physician-prescribed regimen.</description>
    <arm_group_label>Overall Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with chronic renal anemia regardless of pre-dialysis / dialysis in Korea.&#xD;
        Participants who were prescribed Mircera by their physician according to the local Korean&#xD;
        Mircera label, for the treatment of anemia associated with chronic kidney disease who&#xD;
        require ESA therapy could be included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult, aged &gt;18 years&#xD;
&#xD;
          -  Participants with stage 3-5 chronic kidney disease and hemodialyzed participants&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current participation in a clinical study&#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>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <results_first_submitted>June 17, 2016</results_first_submitted>
  <results_first_submitted_qc>June 17, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 28, 2016</results_first_posted>
  <last_update_submitted>July 29, 2016</last_update_submitted>
  <last_update_submitted_qc>July 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>In total, 748 participants were enrolled from 27 sites, of which only 742 participants were used for safety and efficacy analysis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Overall Participants</title>
          <description>Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were prescribed Mircera either subcutaneously (SC) or intravenously (IV) according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="742"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="742"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Overall Participants</title>
          <description>Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="742"/>
          </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="58.7" spread="14.2"/>
                  </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="376"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="366"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event</title>
        <description>An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.</description>
        <time_frame>At physician's discretion, up to 4 years</time_frame>
        <population>Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.</population>
        <group_list>
          <group group_id="O1">
            <title>Overall Participants</title>
            <description>Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event</title>
          <description>An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.</description>
          <population>Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.</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="742"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With an Adverse Drug Reaction (ADR)</title>
        <description>ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as &quot;definitely related&quot;,&quot;probably related&quot;, &quot;possibly related&quot;, and &quot;unknown&quot; by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as &quot;Unexpected&quot;. An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.</description>
        <time_frame>At physician's discretion, up to 4 years</time_frame>
        <population>Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.</population>
        <group_list>
          <group group_id="O1">
            <title>Overall Participants</title>
            <description>Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Adverse Drug Reaction (ADR)</title>
          <description>ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as &quot;definitely related&quot;,&quot;probably related&quot;, &quot;possibly related&quot;, and &quot;unknown&quot; by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as &quot;Unexpected&quot;. An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.</description>
          <population>Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.</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="742"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of ESA Naïve Participants Having an Increase in Hemoglobin (Hb) Level of at Least 1 g/dL From Baseline and Reaching the Hb Level Greater Than or Equal to (&gt;/=) 11 g/dL Without Red Blood Cell Transfusion</title>
        <time_frame>Up to 4 years</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants on ESA Therapy Who Were Switched to Mircera Having a Hemoglobin Concentration in the Range of 10 to 12 g/dL</title>
        <time_frame>Up to 4 years</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 4 years</time_frame>
      <desc>An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.</desc>
      <group_list>
        <group group_id="E1">
          <title>Overall Participants</title>
          <description>Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="742"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="742"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="742"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="742"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="742"/>
              </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>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/NCT02263833
org study id: ML22560
nct id: NCT02263833
lead sponsor: 
has dmc: No
This national study was a post-marketing surveillance study conducted in Korea from 29 August
      2008 to 28 August 2012 to meet local regulatory requirements for Mircera
      (monopegylated-epoetin beta). Prospective participant-based data collection was evaluated for
      safety/risk assessments and effectiveness. No specific study-related procedures are required.
      Participants were to be followed up as long as possible at the physician's discretion.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event
time frame: At physician's discretion, up to 4 years
description: An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.
measure: Percentage of Participants With an Adverse Drug Reaction (ADR)
time frame: At physician's discretion, up to 4 years
description: ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as "definitely related","probably related", "possibly related", and "unknown" by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as "Unexpected". An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.
measure: Percentage of ESA Naïve Participants Having an Increase in Hemoglobin (Hb) Level of at Least 1 g/dL From Baseline and Reaching the Hb Level Greater Than or Equal to (>/=) 11 g/dL Without Red Blood Cell Transfusion
time frame: Up to 4 years
measure: Percentage of Participants on ESA Therapy Who Were Switched to Mircera Having a Hemoglobin Concentration in the Range of 10 to 12 g/dL
time frame: Up to 4 years
arm group label: Overall Participants
description: Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were switched to Mircera
intervention type: Drug
intervention name: Mircera
description: Participants received Mircera according to individualized physician-prescribed regimen.
arm group label: Overall Participants
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
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 