A prospective, pilot study of early corticosteroid cessation in high-immunologic-risk patients: the Cincinnati experience

TitleA prospective, pilot study of early corticosteroid cessation in high-immunologic-risk patients: the Cincinnati experience
Publication TypeJournal Article
Year of Publication2005
AuthorsAlloway RR, Hanaway MJ, Trofe J, Boardman R, Rogers CC, Hanaway MJ, Buell JF, Munda R, Alexander JW, Thomas MJ, Roy-Chaudhury P, Cardi M, Woodle ES
JournalTransplant Proc
Pagination802 - 3
Date PublishedMar
Accession Number15848537
KeywordsAdrenal 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

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.

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