CompletedPhase 3

A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

France127 participantsStarted 2008-06

Plain-language summary

This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis; * continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month. Exclusion Criteria: * transfusion of red blood cells during previous 2 months; * significant acute or chronic bleeding; * poorly controlled hypertension.

What they're measuring

Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period

Timeframe: Weeks 16-24

Trial details

NCT IDNCT00642967

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-08

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