TY - JOUR
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
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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U2 - 10.1097/00007890-200003150-00028
DO - 10.1097/00007890-200003150-00028
M3 - Article
C2 - 10755536
AN - SCOPUS:0034654005
SN - 0041-1337
VL - 69
SP - 834
EP - 841
JO - Transplantation
JF - Transplantation
IS - 5
ER -