@article {57,
	title = {A prospective, pilot study of early corticosteroid cessation in high-immunologic-risk patients: the Cincinnati experience},
	journal = {Transplant Proc},
	volume = {37},
	year = {2005},
	note = {0041-1345 (Print) Clinical Trial Controlled Clinical Trial Journal Article},
	month = {Mar},
	pages = {802 - 3},
	abstract = {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 {\textquoteright}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.},
	keywords = {Adrenal Cortex Hormones / administration \& dosage / *adverse effects, Adult, Aged, Antilymphocyte Serum / therapeutic use, Drug Administration Schedule, Drug Therapy, Combination, Female, Graft Rejection / prevention \& control, Humans, Immunosuppressive Agents / *therapeutic use, Kidney Transplantation / *immunology, Male, Middle Aged, Patient Selection, Pilot Projects, Prospective Studies},
	author = {Alloway,R. R. and Hanaway,M. J. and Trofe,J. and Boardman,R. and Rogers,C. C. and Hanaway,M. J. and Buell,J. F. and Munda,R. and Alexander,J. W. and Thomas,M. J. and Roy-Chaudhury,P. and Cardi,M. and Woodle,E. S.}
}
