A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. FK506 Kidney Transplant Study Group

Transplantation. 1997 Apr 15;63(7):977-83. doi: 10.1097/00007890-199704150-00013.


Background: Tacrolimus (FK506), a macrolide molecule that potently inhibits the expression of interleukin 2 by T lymphocytes, represents a potential major advance in the management of rejection following solid-organ transplantation. This randomized, open-label study compared the efficacy and safety of tacrolimus-based versus cyclosporine-based immunosuppression in patients receiving cadaveric kidney transplants.

Methods: A total of 412 patients were randomized to tacrolimus (n=205) or cyclosporine (n=207) after cadaveric renal transplantation and were followed for 1 year for patient and graft survival and the incidence of acute rejection.

Results: One-year patient survival rates were 95.6% for tacrolimus and 96.6% for cyclosporine (P=0.576). Corresponding 1-year graft survival rates were 91.2% and 87.9% (P=0.289). There was a significant reduction in the incidence of biopsy-confirmed acute rejection in the tacrolimus group (30.7%) compared with the cyclosporine group (46.4%, P=0.001), which was confirmed by blinded review, and in the use of antilymphocyte therapy for rejection (10.7% and 25.1%, respectively; P<0.001). Impaired renal function, gastrointestinal disorders, and neurological complications were commonly reported in both treatment groups, but tremor and paresthesia were more frequent in the tacrolimus group. The incidence of posttransplant diabetes mellitus was 19.9% in the tacrolimus group and 4.0% in the cyclosporine group (P<0.001), and was reversible in some patients.

Conclusions: Tacrolimus is more effective than cyclosporine in preventing acute rejection in cadaveric renal allograft recipients, and significantly reduces the use of antilymphocyte antibody preparations. Tacrolimus was associated with a higher incidence of neurologic events, which were rarely treatment limiting, and with posttransplant diabetes mellitus, which was reversible in some patients.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Adult
  • Antilymphocyte Serum / adverse effects
  • Antilymphocyte Serum / therapeutic use
  • Cadaver
  • Cause of Death
  • Clinical Protocols
  • Creatinine / blood
  • Cross-Over Studies
  • Cyclosporine / adverse effects
  • Cyclosporine / therapeutic use*
  • Diabetes Mellitus / drug therapy
  • Diabetes Mellitus / etiology
  • Female
  • Graft Rejection / blood
  • Graft Rejection / prevention & control*
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Insulin / therapeutic use
  • Kidney Transplantation / immunology*
  • Kidney Transplantation / mortality
  • Male
  • Patient Selection
  • Regression Analysis
  • Tacrolimus / adverse effects
  • Tacrolimus / therapeutic use*


  • Antilymphocyte Serum
  • Immunosuppressive Agents
  • Insulin
  • Cyclosporine
  • Creatinine
  • Tacrolimus