Conditions: Anemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 140
Healthy volunteers: no

Brief summary:
This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Participants currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 grams per deciliter (g/dL).

Detailed description:

Arms:
arm 1: Participants will receive methoxy polyethylene glycol-epoetin beta once monthly by subcutaneous (SC) injection for 28 weeks.

Interventions: intervention 1: Methoxy Polyethylene Glycol-Epoetin Beta
Intervention descriptions: intervention 1: 120, 200 or 360 micrograms every 4 weeks by subcutaneous injection.

Protocol document: