Details

Autor(en) / Beteiligte

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

Titel

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

Ist Teil von

• Clinical transplantation, 2008-03, Vol.22 (2), p.200-210

Erscheinungsjahr

2008

Quelle

Wiley Online Library

Beschreibungen/Notizen

• 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 27months 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 plus or minus 5.5, 64.4 plus or minus 4.5, and 80.7 plus or minus 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.