Evaluating Safety and Efficacy of MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Combination With Low-Dose CsA, Tac or Sir in Comparison to Current Standard Immunosuppression (MMF, CsA and Corticosteroids) in Renal Tx

NCT00231764 Phase 4 COMPLETED

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.

Details

Lead sponsor	Ekberg, Henrik, M.D.
Phase	Phase 4
Status	COMPLETED
Enrolment	1760
Start date	2002-11
Completion	2008-02

Conditions

• Kidney Transplantation

Interventions

• daclizumab

Primary outcomes

• GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation