Randomized trial of tacrolimus plus mycophenolate mofetil or azathioprine versus cyclosporine plus mycophenolate mofetill after cadaveric kidney transplantation: Results at three years.

Methods. Two hundred twenty-three recipients of first cadaveric kidney allografts were randomized to receive tacrolimus (TAC) + mycophenolate mofetil (MMF), TAC + azathioprine (AZA), or cyclosporine (Neoral; CsA) + MMF. All regimens contained corticosteroids, and antibody induction was used only in patients who experienced delayed graft function (DGF). Patients were followed-up for 3 years. Results. The results at 3 years corroborate and extend the findings of the 2-year results. Patients with DGF treated with TAC + MMF experienced an increase in 3-year allograft survival compared with patients receiving CsA + MMF (84.1% vs. 49.9%, P = 0.02). Patients randomized to either treatment arm containing TAC exhibited numerically superior kidney function when compared with CsA. During the 3 years, new-onset insulin dependence occurred in 6, 3, and 11 patients in the TAC + MMF, CsA + MMF, and TAC + AZA treatment arms, respectively. Furthermore, patients randomized to TAC + MMF received significantly lower doses of MMF as compared with those who received CsA + MMF. Conclusion. All three immunosuppressive regimens provided excellent safety and efficacy. However, the best results overall were achieved with TAC + MMF. The combination may provide particular benefit to kidney allograft recipients with DGF. In patients who experienced DGF, graft survival was better at 3 years in those patients receiving TAC in combination with either MMF or AZA as compared with the patients receiving CsA with MMF.