A multicenter randomized controlled trial of HC-A Ⅱ solution in kidney preservation / 中华器官移植杂志

ABSTRACT

ObjectiveTo evaluate the efficacy and safety of HC-A Ⅱsolution in kidney preservation.Methods A multicenter,randomized,double-blind and controlled clinical trial was conducted.Between Jan.2008 and Dec.2010,kidney recipients from 9 transplant centers were randomly divided into two groups.Grafts in each group were perfused and stored in HC-A Ⅱ or HTK solutions respectively.Results277 patients were included in the Full Analysis Set (FAS),137 of whom were inHC-A Ⅱgroup and 140inHTK group. Demographic andbaseline medical characteristics were similar between the two groups.262 patients were included in the Per Protocol Set (PPS),133 of whom were in HC-A Ⅱ group and129 in HTK group.The percentages of patients with a serum creatinine level that returned to normal within 28 days postoperation were 86.9％ in HC-A Ⅱ group and 85.0％ in HTK group respectively (P＞0.05 ).The results from PPS analysis were consistent with those from FAS analysis The incidence of test-related adverse events was 2.9％ in HC-AⅡ group and 0.7％ in HTK group respectively (P＞0.05).No test-related serious adverse events occurred throughout the study.ConclusionHC-A Ⅱ solution,the same as HTK solution,is safe and effective in kidney preservation.