drugset / Trial / NCT00661505

A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia

NCT00661505

Phase 3 Completed 132 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Timeline

Start
2008-05-14
Primary completion
2010-06-22
Completion
2010-06-22

Drugs

EvaluationDrugModalityDoseRoute
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 120 ug Intravenous
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 200 ug Intravenous
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 360 ug Intravenous

Indications