drugset / Trial / NCT00550680

A Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia

NCT00550680

Phase 3 Completed 208 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms \[mcg\] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.

Timeline

Start
2008-01
Primary completion
2009-09
Completion
2009-09

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