A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Darbepoetin alfa; Epoetin Alfa

Criteria

Inclusion Criteria:

• adult patients >=18 years of age;

• chronic renal anemia;

• on dialysis therapy for at least 12 weeks before screening;

• receiving darbepoetin alfa iv for at least 8 weeks before screening.

Exclusion Criteria:

• women who are pregnant, breastfeeding or using unreliable birth control methods;

• administration of another investigational drug within 4 weeks before screening, or during the study period.