MIRACLE Study: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Participants With Chronic Renal Anemia
Status:
Completed
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
participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin
alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting
dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating
agent [ESA] dose administered on Week -1). Subsequent doses will be adjusted to maintain
hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter
[g/dL] for Switzerland and 10 to 12 g/dL for Austria).