BACKGROUND:Between September 20, 1995 and September 20, 1997, 208 adult patients undergoing renal transplantation were randomized to receive tacrolimus/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. The mean donor age was 34.5+/-21.7 years. The mean cold ischemia time was 30.5+/-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 survival 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 97%, and the corresponding 1-year actuarial graft survival was 93%. There were no differences between the two groups. The overall incidence of rejection was 36%; in the double-therapy group, it was 44%, whereas in the triple therapy 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 taken off prednisone; 32% of the patients were taken off antihypertensive medications. The incidence of delayed graft function was 21%, the incidence of cytomegalovirus was 12.5%, and the initial and final incidences of posttransplant insulin-dependent diabetes mellitus were 7.0% and 2.9%; again, there was no difference between the two groups. CONCLUSIONS: This trial suggests that the combination of tacrolimus, steroids, and mycophenolate mofetil is associated with excellent patient and graft survival and a lower incidence of rejection than the combination of tacrolimus and steroids.
RCT Entities:
BACKGROUND: Between September 20, 1995 and September 20, 1997, 208 adult patients undergoing renal transplantation were randomized to receive tacrolimus/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. The mean donor age was 34.5+/-21.7 years. The mean cold ischemia time was 30.5+/-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 survival 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 97%, and the corresponding 1-year actuarial graft survival was 93%. There were no differences between the two groups. The overall incidence of rejection was 36%; in the double-therapy group, it was 44%, whereas in the triple therapy 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 taken off prednisone; 32% of the patients were taken off antihypertensive medications. The incidence of delayed graft function was 21%, the incidence of cytomegalovirus was 12.5%, and the initial and final incidences of posttransplant insulin-dependent diabetes mellitus were 7.0% and 2.9%; again, there was no difference between the two groups. CONCLUSIONS: This trial suggests that the combination of tacrolimus, steroids, and mycophenolate mofetil is associated with excellent patient and graft survival and a lower incidence of rejection than the combination of tacrolimus and steroids.
Authors: R Shapiro; M L Jordan; V P Scantlebury; C Vivas; J J Fung; J McCauley; P Randhawa; A J Demetris; W Irish; A Jain Journal: Transplant Proc Date: 1995-02 Impact factor: 1.066
Authors: F Vincenti; R Kirkman; S Light; G Bumgardner; M Pescovitz; P Halloran; J Neylan; A Wilkinson; H Ekberg; R Gaston; L Backman; J Burdick Journal: N Engl J Med Date: 1998-01-15 Impact factor: 91.245
Authors: R Shapiro; V P Scantlebury; M L Jordan; C A Vivas; A Jain; T R Hakala; J McCauley; J Johnston; P Randhawa; S Fedorek; E Gray; A Chesky; I Dvorchik; J Donaldson; J J Fung; T E Starzl Journal: Transplant Proc Date: 2002-08 Impact factor: 1.066
Authors: R Shapiro; M L Jordan; V P Scantlebury; C Vivas; J W Marsh; J McCauley; J Johnston; P Randhawa; W Irish; H A Gritsch; R Naraghi; T R Hakala; J J Fung; T E Starzl Journal: Transplantation Date: 1999-02-15 Impact factor: 4.939
Authors: R Shapiro; M Nalesnik; J McCauley; S Fedorek; M L Jordan; V P Scantlebury; A Jain; C Vivas; D Ellis; S Lombardozzi-Lane; P Randhawa; J Johnston; T R Hakala; R L Simmons; J J Fung; T E Starzl Journal: Transplantation Date: 1999-12-27 Impact factor: 4.939
Authors: Serge Cremers; Rik Schoemaker; Eduard Scholten; Jan den Hartigh; Jacqueline König-Quartel; Eric van Kan; Leendert Paul; Johan de Fijter Journal: Br J Clin Pharmacol Date: 2005-09 Impact factor: 4.335
Authors: R Shapiro; P Randhawa; M L Jordan; V P Scantlebury; C Vivas; A Jain; R J Corry; J McCauley; J Johnston; J Donaldson; E A Gray; I Dvorchik; T R Hakala; J J Fung; T E Starzl Journal: Am J Transplant Date: 2001-05 Impact factor: 8.086