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

Nasimul Ahsan, Christopher Johnson, Thomas Gonwa, Philip Halloran, Mark Stegall, Mark Hardy, Robert Metzger, Charles Shield, Leslie Rocher, John Scandling, John Sorensen, Laura Mulloy, Jimmy Light, Claudia Corwin, Gabriel Danovitch, Michael Wachs, Paul VanVeldhuisen, Kim Salm, Diane Tolzman, William E. Fitzsimmons

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125 Scopus citations

Abstract

Background. A previous report described the 1-year results of a prospective, randomized trial designed to investigate the optimal combination of immunosuppressants in kidney transplantation. Recipients of first cadaveric kidney allografts were treated with tacrolimus+mycophenolate mofetil (MMF), cyclosporine oral solution (modified) (CsA)+MMF, or tacrolimus+azathioprine (AZA). Results at 1 year revealed that optimal efficacy and safety were achieved with a regimen containing tacrolimus+MMF. The present report describes results at 2 years. Methods. Two hundred twenty-three recipients of first cadaveric kidney allografts were randomized to receive tacrolimus+MMF, CsA+MMF, or tacrolimus+AZA. All regimens contained corticosteroids, and antibody induction was used only in patients who experienced delayed graft function. Patients were followed 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 tacrolimus 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 tacrolimus+MMF experienced a 23% increase in allograft survival compared with patients receiving CsA+MMF (P=0.06). Patients randomized to tacrolimus+MMF received 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 tacrolimus+MMF. The combination may provide particular benefit to kidney allograft recipients who develop delayed graft function/acute tubular necrosis. Renal function at 2 years was better in the tacrolimus treatment groups compared with the CsA group.

Original languageEnglish (US)
Pages (from-to)245-250
Number of pages6
JournalTransplantation
Volume72
Issue number2
DOIs
StatePublished - Jan 1 2001

ASJC Scopus subject areas

  • Transplantation

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    Ahsan, N., Johnson, C., Gonwa, T., 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., Salm, K., Tolzman, D., & Fitzsimmons, W. E. (2001). 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. Transplantation, 72(2), 245-250. https://doi.org/10.1097/00007890-200107270-00014