Conditions: Anemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 233
Healthy volunteers: no

Brief summary:
This 2 arm study will compare the efficacy and safety of monthly administration of subcutaneous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized to receive either monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera] intervention 2: Epoetin alfa
Intervention descriptions: intervention 1: 120, 200 or 360 micrograms sc monthly (starting dose) intervention 2: As prescribed

Protocol document: