Randomized trial of tacrolimus (Prograf) in combination with azathioprine or mychophenolate mofetil versus cyclosporine (Neoral) with mycophenolate mofetil after cadaveric kidney transplantation

Christopher Johnson, Nasimul Ahsan, 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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250 Scopus citations

Abstract

Background. Our clinical trial was designed to investigate the optimal combination of immunosuppressants for renal transplantation. Methods. A randomized three-arm, parallel group, open label, prospective study was performed at 15 North American centers to compare three immunosuppressive regimens: tacrolimus + azathioprine (AZA) versus cyclosporine (Neoral) + mycophenolate mofetil (MMF) versus tacrolimus + MMF. All patients were first cadaveric kidney transplants receiving the same maintenance corticosteroid regimen. Only patients with delayed graft function (32%) received antilymphocyte induction. A total of 223 patients were randomized, transplanted, and followed for 1 year. Results. There were no significant differences in baseline demography between the three treatment groups. At 1 year the results are as follows: acute rejection 17% (95% confidence interval 9%, 26%) in tacrolimus + AZA; 20% (confidence interval 11%, 29%) in cyclosporine + MMF; and 15% (confidence interval 7%, 24%) in tacrolimus + MMF. The incidence of steroid resistant rejection requiring antilymphocyte therapy was 12% in the tacrolimus + AZA group, 11% in the cyclosporine + MMF group, and 4% in the tacrolimus + MMF group. There were no significant differences in overall patient or graft survival. Tacrolimus-treated patients had a lower incidence of hyperlipidemia through 6 months posttransplant. The incidence of posttransplant diabetes mellitus requiring insulin was 14% in the tacrolimus + AZA group, 7% in the cyclosporine + MMF and 7% in the tacrolimus + MMF groups. Conclusions. All regimens yielded similar acute rejection rates and graft survival, but the tacrolimus + MMF regimen was associated with the lowest rate of steroid resistant rejection requiring antilymphocyte therapy.

Original languageEnglish (US)
Pages (from-to)834-841
Number of pages8
JournalTransplantation
Volume69
Issue number5
DOIs
StatePublished - Mar 15 2000

ASJC Scopus subject areas

  • Transplantation

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    Johnson, C., Ahsan, N., 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. (2000). Randomized trial of tacrolimus (Prograf) in combination with azathioprine or mychophenolate mofetil versus cyclosporine (Neoral) with mycophenolate mofetil after cadaveric kidney transplantation. Transplantation, 69(5), 834-841. https://doi.org/10.1097/00007890-200003150-00028