A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. 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: Darbepoetin alfa

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• chronic kidney disease, not requiring dialysis;

• receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.

Exclusion Criteria:

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

• transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;

• active malignant disease;

• previous treatment with Mircera.