Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation: Results at three years

Thomas Gonwa, Christopher Johnson, Nasimul Ahsan, Edward J. Alfrey, 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, Maryanne Leonhardt, William E. Fitzsimmons

Research output: Contribution to journalArticle

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Abstract

Methods. Two hundred twenty-three recipients of first cadaveric kidney allografts were randomized to receive tacrolimus (TAC) + mycophenolate mofetil (MMF), TAC + azathioprine (AZA), or cyclosporine (Neoral; CsA) + MMF. All regimens contained corticosteroids, and antibody induction was used only in patients who experienced delayed graft function (DGF). Patients were followed-up for 3 years. Results. The results at 3 years corroborate and extend the findings of the 2-year results. Patients with DGF treated with TAC+MMF experienced an increase in 3-year allograft survival compared with patients receiving CsA+MMF (84.1% vs. 49.9%, P=0.02). Patients randomized to either treatment arm containing TAC exhibited numerically superior kidney function when compared with CsA. During the 3 years, new-onset insulin dependence occurred in 6, 3, and 11 patients in the TAC+MMF, CsA+MMF, and TAC+AZA treatment arms, respectively. Furthermore, patients randomized to TAC+MMF received significantly lower doses of MMF as compared with those who received CsA+MMF. Conclusion. All three immunosuppressive regimens provided excellent safety and efficacy. However, the best results overall were achieved with TAC+MMF. The combination may provide particular benefit to kidney allograft recipients with DGF. In patients who experienced DGF, graft survival was better at 3 years in those patients receiving TAC in combination with either MMF or AZA as compared with the patients receiving CsA with MMF.

Original languageEnglish (US)
Pages (from-to)2048-2053
Number of pages6
JournalTransplantation
Volume75
Issue number12
DOIs
StatePublished - Jun 27 2003

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Mycophenolic Acid
Azathioprine
Tacrolimus
Kidney Transplantation
Cyclosporine
Delayed Graft Function
Allografts
Kidney
Arm
Graft Survival
Immunosuppressive Agents
Adrenal Cortex Hormones

ASJC Scopus subject areas

  • Transplantation

Cite this

Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation : Results at three years. / Gonwa, Thomas; Johnson, Christopher; Ahsan, Nasimul; Alfrey, Edward J.; 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; Leonhardt, Maryanne; Fitzsimmons, William E.

In: Transplantation, Vol. 75, No. 12, 27.06.2003, p. 2048-2053.

Research output: Contribution to journalArticle

Gonwa, T, Johnson, C, Ahsan, N, Alfrey, EJ, 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, Leonhardt, M & Fitzsimmons, WE 2003, 'Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation: Results at three years', Transplantation, vol. 75, no. 12, pp. 2048-2053. https://doi.org/10.1097/01.TP.0000069831.76067.22
Gonwa, Thomas ; Johnson, Christopher ; Ahsan, Nasimul ; Alfrey, Edward J. ; 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 ; Leonhardt, Maryanne ; Fitzsimmons, William E. / Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation : Results at three years. In: Transplantation. 2003 ; Vol. 75, No. 12. pp. 2048-2053.
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abstract = "Methods. Two hundred twenty-three recipients of first cadaveric kidney allografts were randomized to receive tacrolimus (TAC) + mycophenolate mofetil (MMF), TAC + azathioprine (AZA), or cyclosporine (Neoral; CsA) + MMF. All regimens contained corticosteroids, and antibody induction was used only in patients who experienced delayed graft function (DGF). Patients were followed-up for 3 years. Results. The results at 3 years corroborate and extend the findings of the 2-year results. Patients with DGF treated with TAC+MMF experienced an increase in 3-year allograft survival compared with patients receiving CsA+MMF (84.1{\%} vs. 49.9{\%}, P=0.02). Patients randomized to either treatment arm containing TAC exhibited numerically superior kidney function when compared with CsA. During the 3 years, new-onset insulin dependence occurred in 6, 3, and 11 patients in the TAC+MMF, CsA+MMF, and TAC+AZA treatment arms, respectively. Furthermore, patients randomized to TAC+MMF received significantly lower doses of MMF as compared with those who received CsA+MMF. Conclusion. All three immunosuppressive regimens provided excellent safety and efficacy. However, the best results overall were achieved with TAC+MMF. The combination may provide particular benefit to kidney allograft recipients with DGF. In patients who experienced DGF, graft survival was better at 3 years in those patients receiving TAC in combination with either MMF or AZA as compared with the patients receiving CsA with MMF.",
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T1 - Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation

T2 - Results at three years

AU - Gonwa, Thomas

AU - Johnson, Christopher

AU - Ahsan, Nasimul

AU - Alfrey, Edward J.

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 - Leonhardt, Maryanne

AU - Fitzsimmons, William E.

PY - 2003/6/27

Y1 - 2003/6/27

N2 - Methods. Two hundred twenty-three recipients of first cadaveric kidney allografts were randomized to receive tacrolimus (TAC) + mycophenolate mofetil (MMF), TAC + azathioprine (AZA), or cyclosporine (Neoral; CsA) + MMF. All regimens contained corticosteroids, and antibody induction was used only in patients who experienced delayed graft function (DGF). Patients were followed-up for 3 years. Results. The results at 3 years corroborate and extend the findings of the 2-year results. Patients with DGF treated with TAC+MMF experienced an increase in 3-year allograft survival compared with patients receiving CsA+MMF (84.1% vs. 49.9%, P=0.02). Patients randomized to either treatment arm containing TAC exhibited numerically superior kidney function when compared with CsA. During the 3 years, new-onset insulin dependence occurred in 6, 3, and 11 patients in the TAC+MMF, CsA+MMF, and TAC+AZA treatment arms, respectively. Furthermore, patients randomized to TAC+MMF received significantly lower doses of MMF as compared with those who received CsA+MMF. Conclusion. All three immunosuppressive regimens provided excellent safety and efficacy. However, the best results overall were achieved with TAC+MMF. The combination may provide particular benefit to kidney allograft recipients with DGF. In patients who experienced DGF, graft survival was better at 3 years in those patients receiving TAC in combination with either MMF or AZA as compared with the patients receiving CsA with MMF.

AB - Methods. Two hundred twenty-three recipients of first cadaveric kidney allografts were randomized to receive tacrolimus (TAC) + mycophenolate mofetil (MMF), TAC + azathioprine (AZA), or cyclosporine (Neoral; CsA) + MMF. All regimens contained corticosteroids, and antibody induction was used only in patients who experienced delayed graft function (DGF). Patients were followed-up for 3 years. Results. The results at 3 years corroborate and extend the findings of the 2-year results. Patients with DGF treated with TAC+MMF experienced an increase in 3-year allograft survival compared with patients receiving CsA+MMF (84.1% vs. 49.9%, P=0.02). Patients randomized to either treatment arm containing TAC exhibited numerically superior kidney function when compared with CsA. During the 3 years, new-onset insulin dependence occurred in 6, 3, and 11 patients in the TAC+MMF, CsA+MMF, and TAC+AZA treatment arms, respectively. Furthermore, patients randomized to TAC+MMF received significantly lower doses of MMF as compared with those who received CsA+MMF. Conclusion. All three immunosuppressive regimens provided excellent safety and efficacy. However, the best results overall were achieved with TAC+MMF. The combination may provide particular benefit to kidney allograft recipients with DGF. In patients who experienced DGF, graft survival was better at 3 years in those patients receiving TAC in combination with either MMF or AZA as compared with the patients receiving CsA with MMF.

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