drugset / Trial / NCT00546481

A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.

NCT00546481

Phase 3 Completed 80 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Timeline

Start
2007-11
Primary completion
2009-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator epoetin alfa Protein / enzyme biologic Intravenous
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 0.6 ug/kg Intravenous

Indications