Conditions: Anemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 673
Healthy volunteers: no

Brief summary:
This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: Participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram \[mcg\]) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 International units \[IU\]/Week) administered during the week preceding the switch to the study drug. arm 2: Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 IU/Week) administered during the week preceding the switch to the study drug. arm 3: Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.

Interventions: intervention 1: Epoetin alfa or beta intervention 2: RO0503821 (1x/2 Weeks) intervention 3: RO0503821 (1x/4 Weeks)
Intervention descriptions: intervention 1: intravenously 3 times weekly for 52 weeks, as prescribed intervention 2: 60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks. intervention 3: 120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.

Protocol document: