The introduction of new
immunosuppressants has prompted trials of
steroid withdrawal. However, several groups have reported a higher incidence of rejection. We conducted a randomized two-arm, parallel-group, open-label, prospective study to compare
steroid withdrawal (at 6 months posttransplant) from the regimens of
tacrolimus +
mycophenolate mofetil (MMF) (FK group) versus
cyclosporine + MMF (CSA group). The entry criteria were recipients of first living donor transplants with no
diabetes mellitus (DM),
congestive heart failure, chronic
liver disease, or acute rejection within 6 months posttransplant. The primary endpoint was a biopsy-proven acute rejection episode or treatment failure within 1 year posttransplant. While 87 recipients were assigned to FK (n = 43) and CSA groups (n = 44) before
transplantation, 76 recipients (FK 39, CSA 37) could be tapered off
steroids at 6 months posttransplant, since 11 were excluded due to acute rejection within 6 months posttransplant (FK two, CSA three) or protocol violations (FK two, CSA four). After
steroid withdrawal, the incidence of acute rejection episodes was 0% in the FK group and 13.5% in the CSA group (P < .05). Other results at 12 months posttransplantation were comparable: the incidences of DM 7.8% versus 0% (FK group vs CSA group),
hypercholesterolemia 41.0% versus 59.5%, hypertensives 48.7% versus 59.6% as well as the levels of plasma
creatinine 1.21 +/- 0.24 versus 1.31 +/- 0.50 mg/dL (P > .05 in every variable). These data suggest that
steroid withdrawal is successful in first living donor renal transplant recipients.
Tacrolimus may be significantly more effective than
cyclosporine to prevent acute rejection after
steroid withdrawal.