Overview

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 Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. 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;

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

- receiving IV epoetin 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.