A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary. Participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been receiving.

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

Details

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

Criteria

Inclusion Criteria:

• Adults greater than or equal to (≥) 18 years of age

• Chronic renal anemia

• Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month

• Regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months

Exclusion Criteria:

• Transfusion of red blood cells during previous 2 months

• Poorly controlled hypertension

• Significant acute or chronic bleeding