MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Renal Transplant Patients

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the renal function, as expressed by the glomerular filtration rate at 12 months, in renal transplant recipients receiving mycophenolate mofetil, daclizumab, and corticosteroids as mainstay immunosuppression in combination with low-dose cyclosporine, tacrolimus, or sirolimus, and compare it to that of renal transplant recipients receiving standard immunosuppression with mycophenolate mofetil, normal dose cyclosporine and corticosteroids.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ekberg, Henrik, M.D.
• Collaborators: Hoffmann-La Roche; Prof. Flavio Vincenti, San Francisco, USA (Ass. Steering Committee Member); Prof. Josep Grinyo, Barcelona, Spain (Ass. Steering Committee Member); Prof. Philip Halloran, Edmonton, Canada (sponsor); Prof. Pierre Daloze, Montréal, Canada (Steering Committee Member); Prof. Thomas C. Pearson, Atlanta, USA (Steering Committee Member); Prof. Ulrich Frei, Berlin, Germany (Steering Committee Member); Prof. Yves Vanrenterghem, Leuven, Belgium (Steering Committee Member)
• Treatments: Daclizumab; Immunoglobulin G

Criteria

Inclusion Criteria:

• Male or female patients between 18 - 75 years

• Recipients of single-organ renal primary allograft or second renal transplants (provided that the previous graft was not lost from acute rejection within the first year) from living or cadaver donors

• Patients who provide written informed consent.

Exclusion Criteria:

• PRA > 20% within 6 months prior to enrollment

• Cold ischemia time > 30 hours

• Previous treatment with daclizumab

• History of malignancy (except localized skin cancer)

• Active peptic ulcer disease.