Eculizumab for Prevention of Delayed Graft Function (DGF) in Kidney Transplantation
Status:
Terminated
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Heeger, Peter, M.D.
Collaborators:
Alexion Pharmaceuticals Icahn School of Medicine at Mount Sinai