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

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. 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: Epoetin Alfa

Criteria

Inclusion Criteria:

• adult patients >=18 years of age;

• chronic renal anemia;

• dialysis therapy for at least 2 weeks before screening.

Exclusion Criteria:

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

• administration of any investigational drug within 4 weeks before screening.