Anemia Clinical Trial
Official title:
A Randomized, Open-label Study Comparing the Pharmacoeconomic (Time and Motion) Benefit of Mircera and Epoetin Alfa in Patients With Chronic Kidney Disease (Stage V) on Dialysis.
This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. 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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