drugset / Trial / NCT00642967

A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

NCT00642967

Phase 3 Completed 127 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.

Timeline

Start
2008-06
Primary completion
2010-08
Completion
2010-08

Drugs

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

Indications