Randomized trial of early corticosteroid reduction vs. regular-dose corticosteroid maintenance in combination with tacrolimus and mycophenolate mofetil in living donor kidney transplant recipients: the Brazilian CORRETA trial.
This multicenter, randomized trial aimed to compare the safety and efficacy of an early reduction in corticosteroid dose vs. long-term maintenance in Brazilian patients on an immunosuppressive regimen based on tacrolimus and mycophenolate mofetil (MMF). In the control arm, prednisone was progressively reduced from days 8 to 90 and then kept for 12 months. In the experimental arm, prednisone was given for 12 months at the dose of 5 mg every other day. Endpoints were the composite occurrence of death, graft loss, or Banff III acute rejection, and safety. A total of 83 patients were enrolled, and 77 were analyzed for efficacy safety. One death occurred in each group. There were no cases of graft loss and one case of grade 3 acute rejection in the early reduction arm. There was no difference in the rate of the composite primary endpoint between both arms (p=0.215), and there were no significant differences between both arms in terms of adverse events. Except for higher incidence of hypertriglyceridemia levels among patients in the regular-dose arm, there were no significant differences between both arms in terms of adverse events. The results of this trial suggest that early reduction of corticosteroid can be feasible and safe within a timeframe of 12 months in patients receiving tacrolimus and MMF.
Garcia
Valter D
VD
Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil. vdurogarcia@terra.com.br
Carvalho
Deise B M
DB
Gonçalves
Renato T
RT
Cavalcanti
Ruy L
RL
Campos
Henry H
HH
Abbud-Filho
Mário
M
Lobao-Neto
Abner A
AA
D000293:Adolescent; D000328:Adult; D000368:Aged; D001938:Brazil; D018592:Cross-Over Studies; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006084:Graft Rejection / Q000188:drug therapy*; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D019520:Living Donors; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011241:Prednisone / Q000008:administration & dosage*; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors; D014018:Tissue Distribution; D016896:Treatment Outcome; D055815:Young Adult
D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D011241:Prednisone; D016559:Tacrolimus