A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.
Status:
Withdrawn
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
This single arm study will assess the long-term maintenance of hemoglobin levels, safety and
tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients
with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa
maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360
micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be
adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. The
anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
individuals.