drugset / Trial / NCT00642304

A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.

NCT00642304

Phase 3 Completed 20 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms \[mcg\] subcutaneously \[SC\]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.

Timeline

Start
2008-03-27
Primary completion
2009-12-09
Completion
2009-12-09

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
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 300 ug Subcutaneous

Indications