Eculizumab for Prevention of Delayed Graft Function in Deceased Donor Kidney Transplantation
Detailed Study Description
DGF is both an outcome following kidney transplantation and a predictor for long term graft function. In an era of a tremendous shortage of kidneys for transplantation, every effort should be made to improve the survival of the transplanted kidneys in the recipient. Therefore, it is imperative that we implement strategies to reduce the incidence of DGF in an effort to improve long-term graft survival. There are currently no accepted or FDA approved therapies for prevention or treatment of DGF following transplantation. The Sponsor Investigator of this proposed trial previously performed a pilot study for safety and preliminary efficacy on 8 recipients of first deceased donor kidney transplants at high risk for DGF, half of whom received eculizumab i.v. in the OR prior to reperfusion and the other half received saline as a control. All patients were treated with rabbit anti-thymocyte globulin induction. While 2 of 4 patients in the control group required dialysis for post-transplant DGF, none of the 4 given eculizumab required dialysis. Urine outputs trended to be greater and serum creatinine on Day 30 post-transplant trended lower in the patients given Eculizumab. There was no difference in adverse event rates between the 2 groups. Based on these promising results suggesting efficacy without toxicity we designed this expanded follow up study.