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

Phase 4 Completed 1760 enrolled Ekberg, Henrik, M.D. Hoffmann-La Roche · collab Prof. Flavio Vincenti, San Francisco, USA (Ass. Steering Committee Member) · collab Prof. Josep Grinyo, Barcelona, Spain (Ass. Steering Committee Member) · collab Prof. Philip Halloran, Edmonton, Canada (sponsor) · collab Prof. Pierre Daloze, Montréal, Canada (Steering Committee Member) · collab Prof. Thomas C. Pearson, Atlanta, USA (Steering Committee Member) · collab Prof. Ulrich Frei, Berlin, Germany (Steering Committee Member) · collab Prof. Yves Vanrenterghem, Leuven, Belgium (Steering Committee Member) · collab

RandomizedParallel-groupOpen-label

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.

Timeline

Start: 2002-11
Primary completion: 2006-05
Completion: 2008-02

Publications

Ekberg H, Tedesco-Silva H, Demirbas A, Vitko S, Nashan B, Gurkan A, Margreiter R, Hugo C, Grinyo JM, Frei U, Vanrenterghem Y, Daloze P, Halloran PF; ELITE-Symphony Study. Reduced exposure to calcineurin inhibitors in renal transplantation. N Engl J Med. 2007 Dec 20;357(25):2562-75. doi: 10.1056/NEJMoa067411.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daclizumab	Monoclonal antibody	—	—

Indications

No indication recorded.