Conditions: Anemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 75
Healthy volunteers: no

Brief summary:
This single arm study will assess the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous injections of Mircera at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: Eligible participants will be administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. will be 1.2 micrograms/kilogram. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin within the target range of 10.0 and 12.0 grams/deciliter.

Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: sc every month (starting dose 1.2 micrograms/kg)

Protocol document: