A prospective, randomized trial of tacrolimus/prednisone versus tacrolimus/prednisone mycophenolate mofetil in renal transplant recipients

Background. Between September 20, 1995 and September 20, 1997, 208 adult pa tients undergoing renal transplantation were randomized to receive tacrolim us/prednisone (n=106) or tacrolimus/prednisone/mycophenolate mofetil (n=102 ), with the goal of reducing the incidence of rejection. Methods. The mean recipient age was 50.7 +/- 13.7 years. Sixty-three (30.3% ) patients were 60 years of age or older at the time of transplantation. Th e mean donor age was 34.5 +/- 21.7 years. The mean cold ischemia time was 3 0.5 +/- 9.2 hr, The mean follow-up is 15 +/- 7 months. Results. The overall 1-year actuarial patient survival was 94%; the overall 1-year actuarial graft survival was 87%. When the patient and graft surviv al data were stratified to recipients under the age of 60 who did not have delayed graft function, the overall 1-year actuarial patient survival was 9 7%, and the corresponding 1-year actuarial graft survival was 93%. There we re no differences between the two groups. The overall incidence of rejectio n was 36%; in the double-therapy group, it was 44%, whereas in the triple t herapy group, it was 27% (P = 0.014). The mean serum creatinine was 1.6 +/- 0.8 mg/dl. A total of 36% of the successfully transplanted patients were t aken off prednisone; 32% of the patients were taken off antihypertensive me dications. The incidence of delayed graft function was 21%, the incidence o f cytomegalovirus was 12.5%, and the initial and final incidences of posttr ansplant insulin-dependent diabetes mellitus were 7.0% and 2.9%; again, the re was no difference between the two groups. Conclusions. This trial suggests that the combination of tacrolimus, steroi ds, and mycophenolate mofetil is associated with excellent patient and graf t survival and a lower incidence of rejection than the combination of tacro limus and steroids.