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

Transplantation. 2003 Jun 27;75(12):2048-53. doi: 10.1097/01.TP.0000069831.76067.22.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Azathioprine / therapeutic use*
  • Cadaver
  • Continental Population Groups
  • Creatinine / blood
  • Cyclosporine / therapeutic use*
  • Drug Therapy, Combination
  • Florida
  • Follow-Up Studies
  • Graft Rejection / epidemiology*
  • Graft Survival / immunology
  • Humans
  • Hyperglycemia / epidemiology
  • Kidney Transplantation / immunology*
  • Kidney Transplantation / mortality
  • Kidney Transplantation / physiology
  • Mycophenolic Acid / analogs & derivatives
  • Mycophenolic Acid / therapeutic use*
  • Postoperative Complications / epidemiology
  • Probability
  • Survival Analysis
  • Tacrolimus / therapeutic use*
  • Time Factors
  • Tissue Donors

Substances

  • Cyclosporine
  • Creatinine
  • Mycophenolic Acid
  • Azathioprine
  • Tacrolimus