Randomised trial of simulect versus placebo for control of acute rejection in renal allograft recipients

Objective: To study the efficacy and safety profile of Simulect,anti-IL-2R monoclonal antibody,and prevent the acute rejection in renal allograft recipients.Methods: 46 patients were treated with Neoral-based immunosuppressive agents combined with or without Simulect in March 1999-October 2002 in our organ transplant center.The 46 patients were classified into two groups,group Simulect and group control randomly.The all patients in both groups received Neoral,Azatheoprine and steroid conventionally,but the patients in group Simulect were given Simulect additionally with the first dose of Simulect 20mg,2 hours preoperatively and the second dose of 20 mg 4 days postoperatively.Thereafter,acute rejection,dosage of Neoral,steroids and Azatheoprine as well as the toxicity of these agents and Simulect were closely monitored.In addition,the trough level of CsA in whole blood,liver and renal functions were also monitored.Results: In 8 weeks post-transplantation,3 cases of group control recipients experienced 4 episodes of acute allograft rejection,but none of group Simulect recipients had it（P＜0.01）.No patients in both groups were associate with toxicity,such as cytokin release syndrome,CMV infection and post-transplantation lymphoproliferative disorders（PTLD） and so on.No significant difference of dosage of Neoral and trough level of CsA were found in the patients in both groups.The total dosage of corticosteroids in the patients of the group control was higher than group Simulect because of acute rejection（P＜0.05）.Conclusions: Simulect prevented the recipients of kidney transplantation from acute rejection effectively,with a simple administration,short course and very well safety profile.kidney transplantation;graft rejection;Simulect