M odern corticosteroid therapy for prevention and treatment of rejection continues to be associated with significant morbidity. To date, only 3 randomized, double-blind, placebo-controlled trials of corticosteroid withdrawal (CSWD) have been conducted in renal transplantation. These trials, however, all evaluated withdrawal at 3 months and beyond, and antibody induction therapy was not standardized among centers. The current study is the first randomized, double-blind, placebo-controlled CSWD trial that includes corticosteroid cessation before 3 months after transplantation, as well as standardized antibody induction therapy. The study was designed as a 2-limb study with 1:1 enrollment to either early (7-day) CSWD or longterm corticosteroid maintenance therapy (taper to 5 mg/d by 6 months after transplantation). Inclusion criteria included primary cadaveric and live donor renal transplant patients aged 18 to 70 years. Exclusion criteria included peak panel reactive antibody 50%, current panel reactive antibody 25%, repeat transplant, and multiple organ transplant. The primary end point was treatment failure defined as death, graft loss, or moderate acute rejection (by Banff criteria and treatment) at 6 months and years 1 to 5. Secondary end points included Framingham cardiac risk estimates at 6 months and years 1 to 5, acute rejection, study drug discontinuation, posttransplant diabetes, weight, infection, and malignancy. Patients received tacrolimus (target, 10-20 ng/mL on posttransplant days 1-90; 5-15 ng/mL after posttransplant day 90) and mycophenolate mofetil (2 g/d). Induction therapy was varied by center with interleukin 2 receptor (IL-2R) antibody or Thymoglobulin (1.5 mg/kg 4 doses) (IMTIX-SangStat, Lyon, France). Patients with a decrease in creatinine level of 30% by posttransplant day 3 were randomized either to stop corticosteroids on posttransplant day 7 or to receive long-term corticosteroids. Longterm corticosteroids were given at 5 mg/d after posttransplant day 180. To assess long-term graft survival and cardiac risk, blinding is planned for 5 years. The study included 396 patients who were enrolled before October 2002. Data presented are blinded data from 176 patients. Follow-up lengths included 12 months in 67% of patients, 6 months in 10%, and 3 months in 23%. Eight percent of patients withdrew from the study. Mean age was 46 12 years; 70% of patients were male, 65% white, 25% African American, 45% cadaveric recipients, and 25% had diabetes before transplantation. Mean number of human leukocyte antigen mismatches per patient was 3.3; 94% of patients had current panel reactive antibody 10%. Mean cold ischemia time was 18.8 6.6 hours, 59% received Thymoglobulin induction, and 41% received IL-2R antibody. Biopsyproven acute rejection occurred in 8% of patients, From the Division of Transplantation, Cincinnati, OH; and Fujisawa Healthcare, Inc, Deerfield, IL. The Fujisawa Steroid Withdrawal Study Group consists of the following: E. Steve Woodle, William Fitzsimmons, John D. Pirsch, Fuad Shihab, Osama Gaber, Laurence Chun, Mark Stegall, Alan Langnas, Jonathan Bromberg, Okechukwu Ojogho, Kenneth Washburn, Kristene Gugliuzza, Ravi Parasuraman, Oleh G. Pankewycs, Eugene Schweitzer, John Sorenson, Christopher Johnson, George Loss, George Francos, Paul Morrissey, Raphael Mendez, David Shaffer, Sandip Kapur, J.R. Thistlethwaite, Richard Freeman, Nasimul Ahsan, Thomas Johnston, Arthur Matas, Donald Hricik, Sameh Abul-Ezz, and Rita Alloway. © 2003 Elsevier Inc. All rights reserved. 0955-470X/03/1704-0000$30.00/0 doi:10.1016/j.trre.2003.10.028