A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients
Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
Participant gender:
Summary
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa,
administered at extended dosing intervals, in the maintenance treatment of anemia in patients
with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving
once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to
receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360
micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study)
or intravenous darbepoetin alfa every 2 weeks before switching to once monthly
administration. The anticipated time on study treatment is 3-12 months, and the target sample
size is 100-500 individuals.