TY - JOUR
T1 - Randomized trial of tacrolimus plus mycophenolate mofetil or azathioprine versus cyclosporine oral solution (MODIFIED) plus mycophenolate mofetil after cadaveric kidney transplantation
T2 - Results at 2 years
AU - Ahsan, Nasimul
AU - Johnson, Christopher
AU - Gonwa, Thomas
AU - Halloran, Philip
AU - Stegall, Mark
AU - Hardy, Mark
AU - Metzger, Robert
AU - Shield, Charles
AU - Rocher, Leslie
AU - Scandling, John
AU - Sorensen, John
AU - Mulloy, Laura
AU - Light, Jimmy
AU - Corwin, Claudia
AU - Danovitch, Gabriel
AU - Wachs, Michael
AU - VanVeldhuisen, Paul
AU - Salm, Kim
AU - Tolzman, Diane
AU - Fitzsimmons, William E.
PY - 2001
Y1 - 2001
N2 - 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.
AB - 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.
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U2 - 10.1097/00007890-200107270-00014
DO - 10.1097/00007890-200107270-00014
M3 - Article
C2 - 11477347
AN - SCOPUS:0034905252
SN - 0041-1337
VL - 72
SP - 245
EP - 250
JO - Transplantation
JF - Transplantation
IS - 2
ER -