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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, 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;

• maintenance hemodialysis or peritoneal dialysis for >=2 weeks before screening, and during screening period.

Exclusion Criteria:

• previous therapy with epoetin within 8 weeks prior to screening;

• overt gastrointestinal bleeding within 8 weeks before screening or during screening period;

• RBC transfusions within 8 weeks before screening or during screening period;

• active malignant disease except non-melanoma skin cancer.