Anemia Clinical Trial
Official title:
An Open-label, Randomized, Multicenter, Parallel-group Study to Demonstrate Correction of Anemia Using Once Every 4 Weeks Subcutaneous Injections of Mircera in Patients With Chronic Kidney Disease Who Are Not on Dialysis.
This 2 arm study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Patients will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kg, or darbepoetin alfa once weekly, at a starting dose of 0.45 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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