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

1999; Elsevier BV; Volume: 31; Issue: 1-2 Linguagem: Inglês

10.1016/s0041-1345(98)01935-6

1873-2623

R Shapiro, Mark L. Jordan, Velma P. Scantlebury, Carlos Vivas, J. Wallis Marsh, J McCauley, James R. Johnston, Parmjeet Randhawa, William Irish, H. Albin Gritsch, Ramin Naraghi, T.R. Hakala, John J. Fung, Thomas E. Starzl,

Transplantation: Methods and Outcomes

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.