drugset / Trial / NCT00737711

A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.

NCT00737711

Phase 4 Completed 189 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Timeline

Start
2008-07
Primary completion
2009-10
Completion
2009-10

Drugs

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

Indications