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

Clin Transplant. 2008 Mar-Apr;22(2):200-10. doi: 10.1111/j.1399-0012.2007.00774.x.

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 8-10 ng/mL, mycophenolate mofetil (MMF) 1 g administered twice daily, and maintenance methylprednisolone. In group B, target tacrolimus trough levels were 4-7 ng/mL, 500 mg 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 24 months 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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Alemtuzumab
  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Antibodies, Neoplasm / administration & dosage*
  • Antilymphocyte Serum
  • Black or African American
  • Daclizumab
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Female
  • Graft Rejection / immunology
  • Graft Rejection / prevention & control*
  • Graft Survival*
  • Hispanic or Latino
  • Humans
  • Immunoglobulin G / therapeutic use*
  • Immunosuppressive Agents / administration & dosage*
  • Kaplan-Meier Estimate
  • Kidney Transplantation / immunology
  • Kidney Transplantation / methods*
  • Male
  • Methylprednisolone / therapeutic use
  • Middle Aged
  • Mycophenolic Acid / analogs & derivatives
  • Mycophenolic Acid / therapeutic use
  • Tacrolimus / therapeutic use
  • Transplantation, Homologous
  • White People

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antibodies, Neoplasm
  • Antilymphocyte Serum
  • Immunoglobulin G
  • Immunosuppressive Agents
  • Alemtuzumab
  • Daclizumab
  • thymoglobulin
  • Mycophenolic Acid
  • Tacrolimus
  • Methylprednisolone