A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
Status:
Completed
Trial end date:
2009-12-31
Target enrollment:
Participant gender:
Summary
This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene
glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for
correction and/or maintenance of hemoglobin levels in participants with chronic kidney
disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA)
or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy
polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram
(mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size
was 200 individuals.