Conditions: Anemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 260
Healthy volunteers: no

Brief summary:
This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: 120-360 micrograms (iv) monthly, starting dose arm 2: As prescribed, (iv), 3 times weekly

Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta intervention 2: Epoetin alfa
Intervention descriptions: intervention 1: 120-360 micrograms intravenous (iv) monthly, starting dose intervention 2: As prescribed, iv, 3 times weekly

Protocol document: