TY - JOUR T1 - A prospective, pilot study of early corticosteroid cessation in high-immunologic-risk patients: the Cincinnati experience JF - Transplant Proc Y1 - 2005 A1 - Alloway,R. R. A1 - Hanaway,M. J. A1 - Trofe,J. A1 - Boardman,R. A1 - Rogers,C. C. A1 - Hanaway,M. J. A1 - Buell,J. F. A1 - Munda,R. A1 - Alexander,J. W. A1 - Thomas,M. J. A1 - Roy-Chaudhury,P. A1 - Cardi,M. A1 - Woodle,E. S. KW - Adrenal Cortex Hormones / administration & dosage / *adverse effects KW - Adult KW - Aged KW - Antilymphocyte Serum / therapeutic use KW - Drug Administration Schedule KW - Drug Therapy, Combination KW - Female KW - Graft Rejection / prevention & control KW - Humans KW - Immunosuppressive Agents / *therapeutic use KW - Kidney Transplantation / *immunology KW - Male KW - Middle Aged KW - Patient Selection KW - Pilot Projects KW - Prospective Studies AB - BACKGROUND: The first prospective trial of steroid withdrawal dedicated to high-immunologic-risk patients is reported herein. METHODS: Twenty-five patients were enrolled prospectively in an IRB-approved HIPAA-compliant protocol. Immunosuppression included corticosteroid withdrawal (CSWD) at 7 days, tacrolimus (target trough level 4 to 8 ng/mL), sirolimus (target trough level 8 to 12 ng/mL), and Mycophenolate Mofetil (2 g/d). Induction with daclizumab (2 mg/kg) on posttransplant days (PTD) 0 and 14 was administered to the first 10 patients. The protocol for the next 15 patients was modified because of high acute rejection rates to include received T-cell-depleting antibody induction therapy with thymoglobulin (1.5 mg/kg) on PTDs 0 and 2 followed by daclizumab on Postoperative day (POD) 14. Recipient inclusion criteria included: (1) repeat transplant recipients; or (2) patients with a peak PRA > or =25%. All rejection episodes were diagnosed by biopsy and graded using Banff '97 criteria. RESULTS: Twenty-five patients were enrolled and median follow-up was 402 days. Forty percent of recipients were black, 68% of patients were repeat transplant recipients, 68% received deceased donor kidneys, and 36% had a peak flow PRA >25%. Overall acute rejection, graft survival, and patient survival rates of 40%, 88%, and 96%, respectively, were observed for the duration of the study. Acute rejection occurred in 6 of 10 patients (60%) with daclizumab induction; however, acute rejection rates fell to 27% when thymoglobulin was introduced (P = .1). CONCLUSIONS: This study supports our previous observations in a multivariate analysis of early CSWD patients, wherein polyclonal antibody induction therapy reduced acute rejection. High-immunologic-risk patients may be able to undergo early CSWD with acceptable rates of acute rejection. VL - 37 CP - 2 N1 - 0041-1345 (Print) Clinical Trial Controlled Clinical Trial Journal Article ID - 57 ER -