Alemtuzumab (Campath 1H) Induction With Tacrolimus Monotherapy Is Safe for High Immunological Risk Renal Transplantation

Abstract

Immunosuppression for immunologically high-risk renal transplant patients usually involves antithymocyte globulin induction with triple drug maintenance therapy. Alemtuzumab, a humanized anti-CD52 antibody, has shown promise in tolerogenic induction protocols, requiring minimal maintenance immunosuppression. In this prospective, open-label, randomized, controlled trial, we enrolled 21 high immunological risk patients (i.e., panel reactive antibody>20% or previous transplant). Patients received either single-dose alemtuzumab given before graft reperfusion, with tacrolimus monotherapy, or four doses of Thymoglobulin with tacrolimus, mycophenolate, and steroids. Median follow-up was 377 days. One patient in the Thymoglobulin group who suffered primary graft nonfunction died. One-year cumulative graft survival was 85.7% for the alemtuzumab group and 87.5% for the Thymoglobulin group. Two alemtuzumab and three Thymoglobulin patients suffered rejection episodes. Infection rates were similar. Early results of this ongoing study indicate that a tolerogenic protocol with alemtuzumab induction and tacrolimus maintenance monotherapy is safe in immunologically high-risk renal transplant patients.

Meta-Analysis of Calcineurin-Inhibitor-Sparing Regimens in Kidney Transplantation

“…Total CNI avoidance, 3,5,9 -38 CNI minimization, 17,39 -55 and delayed introduction of CNI 49,50,[55][56][57][58][59][60][61][62] were investigated in 32 (n ϭ 5791), 17 (n ϭ 4131), and 10 studies (n ϭ 1519) respectively. Two studies 50,55 investigated CNI delay followed by minimization: to avoid "double counting" these were analyzed as "delay" studies initially, but if subgroup analyses were necessary (due to heterogeneity), then the same study was considered separately in both the "minimization" and "delay" subanalyses.…”

Terapia de indução com alentuzumabe em receptores de transplante renal

“…This has already been reported in a retrospective study with 14,362 recipients, whose acute rejection incidence at the end of the first year of transplantation was greater in the group of patients receiving alemtuzumab induction as compared with that receiving thymoglobulin (19.2% vs. 10.2%; p< 0.001). 27 Prospective studies have also compared the use of induction therapies with thymoglobulin or alemtuzumab in renal transplant recipients receiving TAC, TAC and MMF, or SRL. 20,21,28 Acute rejection incidences were 18%, 23%, and 28%, respectively.…”

Defining a Steroid Withdrawal Protocol in a newly established Kidney Transplantation Unit

“…Allograft survival was equal in both groups at 87%. These results confi rm that steroid avoidance is not an appropriate alternative for high immunological risk patients, refer to table 4 [48]. Augustine et al 2010, andGaber et al 1996, recommended high risk recipients for instance those with delayed graft function or donor reactive cellular immunity to be identifi ed at the time of transplantation for steroid maintenance [49][50][51].…”