Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived from the dose of darbepoetin alfa or epoetin alfa 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

• Hemoglobin concentration between 10.5 gram per deciliter (g/dL) and 12.5 g/dL

• Adequate iron status (serum ferritin greater than [>] 100 nanogram per milliliter and Transferrin Saturation >20 percent [%] or hypochromic red cells less than [<] 10%)

• Continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months

Exclusion Criteria:

• Transfusion of red blood cells during previous 2 months

• Poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months

• Acute or chronic bleeding

• Active malignant disease (except non-melanoma skin cancer)