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A Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial Comparing Early (7 Day) Corticosteroid Cessation Versus Long-Term, Low-Dose Corticosteroid Therapy


Journal Article

Woodle, S.; First, M.R.; Pirsch, J.; Shihab, F.; Gaber, A.O.; Van Veldhuisen, forthe Astell

Ann Surg




Adolescent; Adult; Aged; Biopsy; Dose-Response Relationship- Drug; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Glucocorticoids; Graft Rejection; Kidney Failure-Chronic; kidney transplantation; Male; Prednisone

{OBJECTIVE: To compare outcomes with early corticosteroid withdrawal (CSWD) and chronic low dose corticosteroid therapy (CCS). SUMMARY BACKGROUND DATA: Final, 5-year results from the first randomized, double-blind, placebo-controlled trial of early CSWD (at 7 days posttransplant) are presented. METHODS: Adult recipients of deceased and living donor kidney transplants without delayed graft function were randomized to receive prednisone (5 mg/d after 6 months posttransplant) or CSWD. Blinding was maintained for 5 years. This clinical trial is registered at (NCT00650468). RESULTS: Results in 386 patients CSWD (n = 191), CCS (n = 195) are presented (CSWD; CCS). No differences were observed at 5 years in the proportion of patients experiencing: primary end point (composite of death, graft loss, or moderate/severe acute rejection) (30/191 (15.7%); 28/195 (14.4%)), patient death (11/191(5.8%);13/195 (6.7%)), death-censored graft loss (11/191 (5.8%); 7/195(3.6%)), biopsy confirmed acute rejection (BCAR) (34/191 (17.8%); 21/195 (10.8%)

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