Randomized trial of tacrolimus plus mycophenolate mofetil or azathioprine versus cyclosporine oral solution (modified) plus mycophenolate mofetil after cadaveric kidney transplantation: Results at 2 years

Background. A previous report described the I-year results of a prospective , randomized trial designed to investigate the optimal combination of immun osuppressants in kidney transplantation. Recipients of first cadaveric kidn ey allografts were treated with tacrolimus+mycophenolate mofetil (MMF), cyc losporine oral solution (modified) (CsA)+MMF, or tacrolimus+azathioprine (A ZA). Results at I year revealed that optimal efficacy and safety were achie ved with a regimen containing tacrolimus+MMF. The present report describes results at 2 years. Methods. Two hundred twenty-three recipients of first cadaveric kidney allo grafts were randomized to receive tacrolimus+MMF, CsA+MMF, or tacrolimus+AZ A. All regimens contained corticosteroids, and antibody induction was used only in patients who experienced delayed graft function. Patients were foll owed up for 2 years. Results. The results at 2 years corroborate and extend the findings of the previous report. Patients randomized to either treatment arm containing tac rolimus experienced improved kidney function. New-onset insulin dependence remained in four, three, and four patients in the tacrolimus+MMF, CsA+MMF, and tacrolimus+AZA treatment arms, respectively. Furthermore, patients with delayed graft function/acute tubular necrosis who were treated with tacrol imus+MMF experienced a 23% increase in allograft survival compared with pat ients receiving CsA+MMF (P=0.06). Patients randomized to tacrolimus+MMF rec eived significantly lower doses of MMF compared with those administered CsA +MMF. Conclusions. All three immunosuppressive regimens provided excellent safety and efficacy. However, the best results overall were achieved with tacroli mus+MMF. The combination may provide particular benefit to kidney allograft recipients who develop delayed graft function/acute tubular necrosis. Rena l function at 2 years was better in the tacrolimus treatment groups compare d with the CsA group.