drugset / Trial / NCT00077766

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

NCT00077766

Phase 3 Completed 313 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Timeline

Start
2004-03
Primary completion
2005-08
Completion
2005-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Darbepoetin alfa Protein / enzyme biologic Intravenous
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 60 ug Intravenous
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 100 ug Intravenous
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 180 ug Intravenous

Indications