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

Transplant Proc. 2005 Mar;37(2):802-3. doi: 10.1016/j.transproceed.2004.12.129.


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.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial

MeSH terms

  • Adrenal Cortex Hormones / administration & dosage
  • Adrenal Cortex Hormones / 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


  • Adrenal Cortex Hormones
  • Antilymphocyte Serum
  • Immunosuppressive Agents