Conditions: Renal Anemia, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 307
Healthy volunteers: no

Brief summary:
This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45 mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is 3-12 months.

Detailed description:

Arms:
arm 1: Participants will receive Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks. arm 2: Participants will receive darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.

Interventions: intervention 1: Methoxy polyethylene glycol-epoetin beta intervention 2: Darbepoetin alfa
Intervention descriptions: intervention 1: 1.2 mcg/kg SC monthly, starting dose intervention 2: 0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose

Protocol document: