NCT01919346

Eculizumab for Prevention of Delayed Graft Function (DGF) in Kidney Transplantation

Eculizumab for Prevention of Delayed Graft Function in Deceased Donor Kidney Transplantation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Heeger, Peter, M.D. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Delayed Graft Function
• Kidney Transplantation
• Complement Activity

Interventions

Type	Name	Description
DRUG	Eculizumab
DRUG	Normal Saline

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2013-08-09
• Last updated: 2018-02-27

Locations

5 sites across 1 country: United States