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

• Status: Completed
• Trial end date: 2009-12-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Chronic renal anemia

• Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks

Exclusion Criteria:

• Transfusion of red blood cells during previous 8 weeks

• Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months

• Acute or chronic bleeding requiring therapy within previous 8 weeks