A prospective, randomized trial of tacrolimus/prednisone vs tacrolimus/prednisone/mycophenolate mofetil in renal transplantation: 1-year actuarial follow-up

Abstract

BETWEEN September 10, 1995, and September 20, 1997, a total of 208 adult patients undergoing their first or second cadaveric renal transplantation alone were randomized to receive tacrolimus!prednisone (n = 106) or tacrolimus/prednisone/mycophenolate mofetil (n = 102), without induction antilymphocyte antibody therapy. The mean recipient age was 50.8 ::!:: 13.7 years (range 19 to 84). Thirty-one (14.9%) patients were undergoing their second transplant, and 11 (5.3%) had a panel-reactive antibody level of over 40%. Sixty-three (30.3%) patients were 60 years of age or older at the time of transplantation, and 16 (7.7%) patients had undergone previous liver or heart transplantation. The mean donor age was 34.5 ::!:: 21.7 years (range 0.01 to 76.5). Twenty-eight (13.5%) donors were 60 years of age or older, and 25 (12.0%) donors were 3 years of age or younger, and were transplanted en bloc. The mean cold ischemia time was 30.5 ::!:: 9.2 hours (range 4.7 to 57.!). The mean number of HLA matches and mismatches was 2.5 ::!:: 1.4 and 3.1 ::!:: 1.5, respectively. There were 17 (8.2%) 0 antigen mismatches. The mean follow-up was 15 ::!:: 17 months. The data were analyzed by intention-to-treat. The overall I-year actuarial patient survival was 94%; in the double therapy group, it was 93%, and in the triple therapy group, it was 96%. Overall I-year actuarial graft survival was 87%; in the double therapy group, it was 85%, and in the triple therapy group, it was 89%. When the patient and graft survival data were stratified to recipients under the age of 60 who did not have delayed graft function, the overall I-year actuarial patient survival was 97%, 95% in the double therapy group, and 98% in the triple therapy group. The corresponding l-year actuarial graft survival was 93%,92% in the double therapy group, and 93% in the triple therapy group. The mean serum creatinine was 1.6 ::!:: 0.8 mg/dL, 1.6 ::!:: 0.9 mg/dL in the double therapy group and 1.7 ::!:: 0.7 mg/dL in the triple therapy group. The mean tacrolimus dose was 8.7 ::!:: 6.6 mg/d; in the double therapy group it was 8.4 ::!:: 6.0 mg/d, and in the triple therapy group, it was 9.0 ::!:: 7.1 mg/d. The mean tacrolimus level was 10.1 ::!:: 4.4 ng/mL; in the double therapy group, it was 10.2 ::!:: 4.5 ng/mL, while in the triple therapy group, it was 10.1 ::!:: 4.2 ng/mL. The mean MMF dose in the patients taking MMF was 1142 ::!:: 493 mg/d. Thirty-six percent of the successfully transplanted patients were taken off prednisone. 34% in the double therapy