<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/NCT01667380</url>
  </required_header>
  <id_info>
    <org_study_id>ML25617</org_study_id>
    <nct_id>NCT01667380</nct_id>
  </id_info>
  <brief_title>An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)</brief_title>
  <official_title>Non-interventional Study on the Use of Mircera in the Treatment of Chronic Renal Anemia in Patients With Chronic Kidney Disease Stages III-IV Not on Dialysis and in Patients on Stage V on Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene&#xD;
      glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on&#xD;
      dialysis or CKD stage V on dialysis. Patients will be followed during 12 months of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Dosage/schedule of Mircera treatment in clinical practice</measure>
    <time_frame>approximately 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with mean Hb level 10-12 g/dL 10 to 12 months after initiation of treatment</measure>
    <time_frame>approximately 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hb levels</measure>
    <time_frame>from baseline to Month 12</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">78</enrollment>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage&#xD;
        V on dialysis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  Patients with chronic renal anemia with stage III-IV CKD not on dialysis and who are,&#xD;
             in the opinion of the treating physician, not expected at baseline to require dialysis&#xD;
             within 12 months&#xD;
&#xD;
          -  Patients with chronic renal anemia with stage V CKD on dialysis&#xD;
&#xD;
          -  No contraindication to ESA treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Hypersensitivity to the active substance or any other of the excipients of Mircera and&#xD;
             other ESAs&#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>Podgorica</city>
        <zip>81 000</zip>
        <country>Montenegro</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Montenegro</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01667380
org study id: ML25617
nct id: NCT01667380
lead sponsor: 
This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene
      glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on
      dialysis or CKD stage V on dialysis. Patients will be followed during 12 months of treatment.
observational model: Cohort
time perspective: Prospective
measure: Dosage/schedule of Mircera treatment in clinical practice
time frame: approximately 3 years
measure: Proportion of patients with mean Hb level 10-12 g/dL 10 to 12 months after initiation of treatment
time frame: approximately 3 years
measure: Change in Hb levels
time frame: from baseline to Month 12
arm group label: Cohort
study pop: 
sampling method: 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: Montenegro
responsible party type: Sponsor
mesh term: Anemia