A Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms [mcg] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa 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:

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

• Chronic renal anemia

• Stable epoetin alfa or darbepoetin alfa therapy for past 2 months

• Hemodialysis therapy for ≥3 months

Exclusion Criteria:

• Transfusion of red blood cells during previous 2 months

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

• Acute or chronic bleeding