A comparison of MIRCERA with reference erythropoiesis-stimulating agents (ESAs) for the treatment of anemia in chronic kidney disease (MIRCERA)

A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs) (MIRCERA)

  • Chronic Kidney Disease
Trial Status:

Completed

This trial runs in
Countries
Trial Identifier:

NCT00773513

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving ESA treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs in accordance with their prescribed dosing information.

      F. Hoffmann-La Roche Ltd Sponsor
      Phase 4 Phase
      NCT00773513 Trial Identifier
      Darbepoetin Alfa, Epoetin Alfa, Epoetin Beta, methoxy polyethylene glycol-epoetin beta Treatments
      Chronic Renal Anemia Condition
      Official Title

      A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)

      Eligibility Criteria

      All Gender
      18 Years and older Age
      No Healthy Volunteers
      Inclusion Criteria
      • Male or female participants with symptomatic anemia associated with CKD
      • Participants with renal anemia who are not treated with an ESA:
      • Anemia was defined as hemoglobin (Hb) concentration less than (<) 11.0 grams per deciliter (g/dL) (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements) with clinical indication for ESA treatment
      • Participants with renal anemia who are on maintenance ESA therapy:
      • If on dialysis: regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 3 months before screening
      • Hb concentration between 10 and 12 g/dL (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements)
      • Participants with adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter or transferrin saturation above or equal to 20 percent
      Exclusion Criteria
      • Contraindications to ESA treatment: uncontrolled hypertension, hypersensitivity to the active substance or any of the excipients, any other contraindication to ESA therapy
      • Conditions known to cause inadequate response to ESA treatment or anemia other than symptomatic anemia associated with CKD:
      • History of hemoglobinopathy
      • Anemia due to hemolysis
      • Pure red cell aplasia
      • High likelihood of early withdrawal (for example, within 1 year) or interruption of the study
      • Pregnancy or breast-feeding
      • Women of childbearing potential without effective contraception
      • Administration of another investigational drug within 1 month before screening or planned during the study period

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