A prospective, randomized, multicenter, double-blind study of early corticosteroid cessation versus long-term maintenance of corticosteroid therapy with tacrolimus and mycophenolate mofetil in primary renal transplant recipients: one year report.

Publication Type
Journal Article
Year of Publication
Woodle, E S; Fujisawa Corticosteroid Withdrawal Study Group
Transplant Proc
Date Published
2005 Mar
Acute Disease; Adrenal Cortex Hormones; Antilymphocyte Serum; Biopsy; Creatinine; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Graft Rejection; Humans; Intraoperative Care; kidney transplantation; Mycophenolic Acid; Prospective Studies; Survival Analysis; Tacrolimus; Time Factors; Treatment Failure

This report summarizes year 1 blinded data from a 5-year prospective, randomized (1:1, stratified by race and donor type), multicenter, double-blind study comparing treatment failure rates between early cessation of corticosteroid therapy and long-term corticosteroid maintenance therapy in 397 primary renal transplant recipients receiving tacrolimus and mycophenolate mofetil with antibody induction. Sixteen (4.1%) patients died or experienced graft loss during year 1 (9 deaths, 6 graft losses, and 1 death with a graft loss). Fifty-nine (15.3%) patients experienced rejection; 40 (10.4%) of these cases were biopsy-confirmed. Values for 10-year predictive risk of coronary heart disease (CHD) estimated from the Framingham Heart Study scores showed a shift from baseline toward a more favorable risk profile. Renal transplant recipients treated with a tacrolimus-based immunosuppressive regimen and either early cessation or maintenance of corticosteroid therapy experienced excellent patient and graft survival, low acute rejection rates, low rate of posttransplantation diabetes mellitus (9.0%), and improved CHD risk profile at 1 year posttransplantation.