Conditions: Anemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 424
Healthy volunteers: no

Brief summary:
This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa

Protocol document: