A randomized trial of thymoglobulin vs. alemtuzumab (with lower dose maintenance immunosuppression) vs. daclizumab in renal transplantation at 24 months of follow-up

Gaetano Ciancio, George W. Burke, Jeffrey J. Gaynor, David Roth, Warren Kupin, Anne Rosen, Tatiana Cordovilla, Lissett Tueros, Eva Herrada, Joshua Miller

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83 Scopus citations

Abstract

Introduction: A long-term prospective randomized trial evaluating alemtuzumab, a humanized anti-CD52 monoclonal antibody, in a predominantly non-Caucasian population has yet to be reported. Methods: Ninety deceased donor (DD) first renal transplant recipients were randomized into three different antibody induction groups: group A, thymoglobulin (Thymo); group B, alemtuzumab; group C, daclizumab (Dac). In groups A and C, the target trough levels of tacrolimus were 8-10ng/ mL, mycophenolate mofetil (MMF) 1g administered twice daily, and maintenance methylprednisolone. In group B, target tacrolimus trough levels were 4-7ng/mL, 500mg MMF administered twice-daily, without methylprednisolone. African-Americans and Hispanics comprised more than 50% in each group. Results: A minimum follow-up of 27 months showed no overall group differences in patient or graft survival (p = 0.89 and 0.66), but a trend towards worse death-censored graft survival in group B (p = 0.05). Acute rejection rates were not significantly different: six (20%), seven (23%), and seven (23%) in groups A, B, and C, respectively. The incidence of chronic allograft nephropathy was higher in group B than in A and C (p = 0.008). The mean calculated creatinine clearance at 24months was 81.1 ± 5.5, 64.4 ± 4.5, and 80.7 ± 5.7 in groups A, B, and C, respectively (p = 0.01 for B vs. average of A and C). Conclusion: In this randomized 27-month minimum follow-up trial of predominantly non-Caucasian DD renal transplant recipients with alemtuzumab induction, lower maintenance tacrolimus, MMF, and steroid avoidance appear less effective than either Thymo or Dac with higher maintenance immunosuppression.

Original languageEnglish (US)
Pages (from-to)200-210
Number of pages11
JournalClinical Transplantation
Volume22
Issue number2
DOIs
StatePublished - Mar 1 2008

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Keywords

  • African-Americans
  • Alemtuzumab
  • Campath-1H
  • Daclizumab
  • Hispanics
  • Mycophenolate mofetil
  • Tacrolimus
  • Thymoglobulin

ASJC Scopus subject areas

  • Transplantation
  • Immunology

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