title: A prospective, pilot study of early corticosteroid cessation in high-immunologic-risk patients: the Cincinnati experience.
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 '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.
authors.affiliation: Division of Transplantation, University of Cincinnati, Cincinnati, Ohio 45249, USA.
authors.forename: R R
authors.initials: RR
authors.lastname: Alloway
authors.forename: M J
authors.initials: MJ
authors.lastname: Hanaway
authors.forename: J
authors.initials: J
authors.lastname: Trofe
authors.forename: R
authors.initials: R
authors.lastname: Boardman
authors.forename: C C
authors.initials: CC
authors.lastname: Rogers
authors.forename: M J
authors.initials: MJ
authors.lastname: Hanaway
authors.forename: J F
authors.initials: JF
authors.lastname: Buell
authors.forename: R
authors.initials: R
authors.lastname: Munda
authors.forename: J W
authors.initials: JW
authors.lastname: Alexander
authors.forename: M J
authors.initials: MJ
authors.lastname: Thomas
authors.forename: P
authors.initials: P
authors.lastname: Roy-Chaudhury
authors.forename: M
authors.initials: M
authors.lastname: Cardi
authors.forename: E S
authors.initials: ES
authors.lastname: Woodle
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000009:adverse effects*; D000328:Adult; D000368:Aged; D000961:Antilymphocyte Serum / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D010865:Pilot Projects; D011446:Prospective Studies
chemical_list: D000305:Adrenal Cortex Hormones; D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents