drugset / Trial / NCT00737464

A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

NCT00737464

Phase 4 Completed 132 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 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
2008-08-26
Primary completion
2009-09-12
Completion
2009-09-12

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