drugset / Trial / NCT00081484

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

NCT00081484

Phase 3 Completed 336 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Timeline

Start
2004-06
Primary completion
2006-03
Completion
2006-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator epoetin alfa Protein / enzyme biologic Intravenous
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 30 ug Intravenous
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 50 ug Intravenous
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 90 ug Intravenous

Indications