Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
21 participants in 2 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal