drugset / Trial / NCT00422513

A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

NCT00422513

Phase 3 Terminated 260 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2007-03
Primary completion
2007-12
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator epoetin alfa Protein / enzyme biologic Intravenous
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 120 ug Intravenous
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 360 ug Intravenous

Indications