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 D 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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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
StatePublished - Mar 15 2000

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Mycophenolic Acid
Azathioprine
Tacrolimus
Kidney Transplantation
Cyclosporine
Graft Survival
Confidence Intervals
Immunosuppressive Agents
Incidence
Steroids
Delayed Graft Function
Hyperlipidemias
Diabetes Mellitus
Adrenal Cortex Hormones
Arm
Therapeutics
Maintenance
Demography
Clinical Trials
Prospective Studies

ASJC Scopus subject areas

  • Transplantation
  • Immunology

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Randomized trial of tacrolimus (Prograf) in combination with azathioprine or mychophenolate mofetil versus cyclosporine (Neoral) with mycophenolate mofetil after cadaveric kidney transplantation. / Johnson, Christopher; Ahsan, Nasimul; Gonwa, Thomas; Halloran, Philip; Stegall, Mark D; Hardy, Mark; Metzger, Robert; Shield, Charles; Rocher, Leslie; Scandling, John; Sorensen, John; Mulloy, Laura; Light, Jimmy; Corwin, Claudia; Danovitch, Gabriel; Wachs, Michael; VanVeldhuisen, Paul; Salm, Kim; Tolzman, Diane; Fitzsimmons, William E.

In: Transplantation, Vol. 69, No. 5, 15.03.2000, p. 834-841.

Research output: Contribution to journalArticle

Johnson, C, Ahsan, N, Gonwa, T, Halloran, P, Stegall, MD, 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, WE 2000, 'Randomized trial of tacrolimus (Prograf) in combination with azathioprine or mychophenolate mofetil versus cyclosporine (Neoral) with mycophenolate mofetil after cadaveric kidney transplantation', Transplantation, vol. 69, no. 5, pp. 834-841.
Johnson, Christopher ; Ahsan, Nasimul ; Gonwa, Thomas ; Halloran, Philip ; Stegall, Mark D ; Hardy, Mark ; Metzger, Robert ; Shield, Charles ; Rocher, Leslie ; Scandling, John ; Sorensen, John ; Mulloy, Laura ; Light, Jimmy ; Corwin, Claudia ; Danovitch, Gabriel ; Wachs, Michael ; VanVeldhuisen, Paul ; Salm, Kim ; Tolzman, Diane ; Fitzsimmons, William E. / Randomized trial of tacrolimus (Prograf) in combination with azathioprine or mychophenolate mofetil versus cyclosporine (Neoral) with mycophenolate mofetil after cadaveric kidney transplantation. In: Transplantation. 2000 ; Vol. 69, No. 5. pp. 834-841.
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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.",
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T1 - Randomized trial of tacrolimus (Prograf) in combination with azathioprine or mychophenolate mofetil versus cyclosporine (Neoral) with mycophenolate mofetil after cadaveric kidney transplantation

AU - Johnson, Christopher

AU - Ahsan, Nasimul

AU - Gonwa, Thomas

AU - Halloran, Philip

AU - Stegall, Mark D

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 - 2000/3/15

Y1 - 2000/3/15

N2 - 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.

AB - 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.

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