A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
Summary
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the
treatment of anemia in patients with chronic kidney disease who are not on dialysis and who
are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized
either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly
subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the
weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The
anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
individuals.