A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia
Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
Participant gender:
Summary
This single arm study will assess the efficacy, safety and tolerability of once-monthly
administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the
maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia.
Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will
receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on
the erythropoietin stimulating agent [ESA] dose administered on week -1). Subsequent doses
will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per
deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample
size is 100-500 individuals.