Randomized trial of tacrolimus plus mycophenolate mofetil or azathioprine versus cyclosporine plus mycophenolate mofetill after cadaveric kidney transplantation: Results at three years. TRANSPLANTATION Gonwa, T., Johnson, C., Ahsan, N., Alfrey, E. J., Halloran, P., Stegall, M., Hardy, M., Metzger, R., Shield, C., Rocher, L., Scandling, J., Sorensen, J., Mulloy, L., Light, J., Corwin, C., Danovitch, G., WACHS, M., VanVeldhuisen, P., Leonhardt, M., Fitzsimmons, W. E. 2003; 75 (12): 2048-2053

Abstract

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.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.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.

View details for DOI 10.1097/01.TP.0000069831.76067.22

View details for Web of Science ID 000183910400023

View details for PubMedID 12829910