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

Academic Article

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 <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. © 2005 by Elsevier Inc. All rights reserved.
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    Author List

  • Alloway RR; Hanaway MJ; Trofe J; Boardman R; Rogers CC; Buell JF; Munda R; Alexander JW; Thomas MJ; Roy-Chaudhury P
  • Start Page

  • 802
  • End Page

  • 803
  • Volume

  • 37
  • Issue

  • 2