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 L Mulloy, Jimmy Light, Claudia Corwin, Gabriel Danovitch, Michael Wachs, Paul VanVeldhuisen, Kim Salm, Diane Tolzman, William E. Fitzsimmons

Research output: Contribution to journalArticle

123 Citations (Scopus)

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

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Mycophenolic Acid
Azathioprine
Tacrolimus
Kidney Transplantation
Cyclosporine
Delayed Graft Function
Allografts
Kidney
Immunosuppressive Agents
Arm
Necrosis
Safety

ASJC Scopus subject areas

  • Transplantation

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

In: Transplantation, Vol. 72, No. 2, 01.01.2001, p. 245-250.

Research output: Contribution to journalArticle

Ahsan, N, Johnson, C, Gonwa, T, Halloran, P, Stegall, M, Hardy, M, Metzger, R, Shield, C, Rocher, L, Scandling, J, Sorensen, J, Mulloy, LL, Light, J, Corwin, C, Danovitch, G, Wachs, M, VanVeldhuisen, P, Salm, K, Tolzman, D & Fitzsimmons, WE 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, vol. 72, no. 2, pp. 245-250. https://doi.org/10.1097/00007890-200107270-00014
Ahsan, Nasimul ; Johnson, Christopher ; Gonwa, Thomas ; Halloran, Philip ; Stegall, Mark ; Hardy, Mark ; Metzger, Robert ; Shield, Charles ; Rocher, Leslie ; Scandling, John ; Sorensen, John ; Mulloy, Laura L ; Light, Jimmy ; Corwin, Claudia ; Danovitch, Gabriel ; Wachs, Michael ; VanVeldhuisen, Paul ; Salm, Kim ; Tolzman, Diane ; Fitzsimmons, William E. / 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. In: Transplantation. 2001 ; Vol. 72, No. 2. pp. 245-250.
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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.",
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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 L

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.

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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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