Conditions: Anemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 35
Healthy volunteers: no

Brief summary:
This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.

Detailed description:

Arms:
arm 1: Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.

Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta
Intervention descriptions: intervention 1: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)

Protocol document: