Eculizumab for Prevention of Delayed Graft Function in Deceased Donor Kidney Transplantation
The purpose of this study is to evaluate the efficacy of Eculizumab in the prevention of Delayed Graft Function following deceased donor kidney transplantation. Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion (IR) injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It is further hypothesized that Eculizumab, a humanized monoclonal antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent IR injury in high risk recipients. This trial is a prospective, randomized study to test the efficacy of eculizumab vs. placebo given once at the time of transplantation and once again 24 hours later in preventing delayed graft function in first adult recipients of deceased donor kidneys.
• Age 18 years or older
• Weight \> 40 kg
• Male or Female
• Recipient of first deceased donor kidney
• Able to provide written informed consent
• Transplant candidate as per site specific guidelines
• Dialysis dependent renal failure (initiated more than 2 months prior to transplant)
• Recipients of kidneys defined as:
‣ Extended Criteria Donor (ECD) kidney with brain death: Kidney donors 60 years of age or older; or donors aged 50-59 years and have two of the following features: Hypertension, terminal serum creatinine \> 1.5 mg/dL, or death from cerebrovascular accident (CVA), OR
⁃ Standard Criteria Donor (SCD) kidney with actual cold ischemia time (CIT) 18 - 40 hours