drugset / Trial / NCT00737477

A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis

NCT00737477

Phase 3 Completed 96 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving.

Timeline

Start
2008-09-30
Primary completion
2011-07-31
Completion
2011-07-31

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