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Clinical Trial Summary

The purpose of this study is to determine if Eculizumab is safe and effective in the prevention of delayed graft function following deceased donor kidney transplantation.


Clinical Trial 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 is further hypothesized that eculizumab, an antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients. To test this hypothesis, this study is a pilot prospective, randomized study to test the efficacy of eculizumab vs. placebo given once at the time of transplantation in preventing delayed graft function in first adult recipients of deceased donor kidneys. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01403389
Study type Interventional
Source Schroppel, Bernd, M.D.
Contact
Status Terminated
Phase Phase 2
Start date December 1, 2011
Completion date February 6, 2014

See also
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Withdrawn NCT02658162 - A Study on SANGUINATEā„¢ for the Reduction of Delayed Graft Function in Kidney Transplant Patients Phase 2
Recruiting NCT01513707 - The Effects of Pre-transplant Dialysis Modality on Post-transplant Events N/A
Recruiting NCT02621281 - Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients N/A
Completed NCT02490202 - Efficacy and Safety of SANGUINATEā„¢ for Reduction of Delayed Graft Function in Patients Receiving a Kidney Transplant Phase 2/Phase 3