A randomized trial of thymoglobulin vs. alemtuzumab (with lower dose maintenance immunosuppression) vs. daclizumab in renal transplantation at 24 months of follow-up
Article first published online: 8 NOV 2007
© 2007 Blackwell Munksgaard
Volume 22, Issue 2, pages 200–210, March/April 2008
How to Cite
Ciancio, G., Burke, G. W., Gaynor, J. J., Roth, D., Kupin, W., Rosen, A., Cordovilla, T., Tueros, L., Herrada, E. and Miller, J. (2008), A randomized trial of thymoglobulin vs. alemtuzumab (with lower dose maintenance immunosuppression) vs. daclizumab in renal transplantation at 24 months of follow-up. Clinical Transplantation, 22: 200–210. doi: 10.1111/j.1399-0012.2007.00774.x
- Issue published online: 8 NOV 2007
- Article first published online: 8 NOV 2007
- Accepted for publication 26 September 2007
- mycophenolate mofetil;
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.