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Free Content A Prospective Randomized Trial of Steroid-Free Maintenance Regimens in Kidney Transplant Recipients—An Interim Analysis

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We compared three maintenance immunosuppressive regimens in a rapid discontinuation of prednisone protocol. From March 1, 2001, through December 31, 2003, 239 first and second kidney transplant recipients (166 LD; 73 DD) were randomized. All recipients were treated with Thymoglobulin; all received steroids intraoperatively and for 5 days postoperatively. Randomization was to cyclosporine–mycophenolate mofetil (n = 85); high-level tacrolimus (TAC) (8–12 ng/mL)–low-level sirolimus (SRL) (3–7 ng/mL) (n = 72); or low-level TAC (3–7 ng/mL)–high-level SRL (8–12 ng/mL) (n = 82). We found no difference at 24 months between groups in patient, graft, death-censored graft, or acute rejection-free graft survival, or in kidney function.

Wound complications were more common in SRL-treated recipients (p = 0.02); we found no other differences between groups in complication rates. Our data suggest that excellent patient and graft survival and low rejection rates can be obtained using a variety of maintenance protocols without prednisone.
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Keywords: Immunosuppression; kidney transplant; prospective; śteroid-free

Document Type: Research Article

Affiliations: Department of Surgery, University of Minnesota, Minneapolis, MN

Publication date: June 1, 2005

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