NCT01756508

Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury

Study of Eculizumab for Prevention and Treatment Reperfusion Injury in Kidney Transplantation.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Russian Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 12 Months – 80 Years
• Healthy volunteers: Not accepted

Summary

Study of eculizumab ability to correct the reperfusion injury of the kidney allograft.

Detailed description

Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It was further hypothesized that eculizumab, antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients. For testing this hypothesis, this study is a pilot prospective study to test the efficacy of eculizumab in preventing the development of reperfusion injury and contribute graft survival.

Conditions

• End-Stage Renal Disease
• Kidney Failure
• Graft Reperfusion Injury

Interventions

Type	Name	Description
DRUG	eculizumab	Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion

Timeline

• Start date: 2012-09-01
• Primary completion: 2017-04-15
• Completion: 2017-12-01
• First posted: 2012-12-27
• Last updated: 2018-08-31

Locations

1 site across 1 country: Russia