A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This two arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. 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, > or = 18 years of age;

• kidney transplant recipients with stage 3 or stage 4 chronic kidney disease;

• functioning graft of > 6 months and < 10 years after kidney transplantation, with no signs of acute rejection;

• stable maintenance subcutaneous darbepoetin alfa therapy every 2 weeks.

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months;

• poorly controlled hypertension;

• significant acute or chronic bleeding;

• need for dialysis therapy expected in next 6 months.