drugset / Trial / NCT01191983

A Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) for the Treatment of Chronic Renal Anemia in Participants With Diabetic Nephropathy

NCT01191983

Phase 4 Completed 102 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single arm, open label study will assess the efficacy, safety and tolerability of methoxy polyethylene glycol-epoetin beta for the treatment of chronic renal anemia in participants with chronic kidney disease (CKD) secondary to diabetes. Participants who are not on dialysis and not currently treated with erythropoiesis stimulating agents (ESAs) will receive methoxy polyethylene glycol-epoetin beta subcutaneously every 4 weeks (Q4W). The starting dose of 1.2 microgram/kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta will be adjusted according to hemoglobin levels. Anticipated time on study treatment is 28 weeks.

Timeline

Start
2010-08-13
Primary completion
2018-04-23
Completion
2018-04-23

Drugs

EvaluationDrugModalityDoseRoute
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 1.2 ug/kg Subcutaneous

Indications