Clinical trial NCT01403389: A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant
Official title: Pilot Study of the Clinical Activity of Eculizumab for Prevention of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Delayed Function of Renal Transplant
Keywords: Kidney Transplant
Delayed Graft Function
Lead sponsor: Schroppel, Bernd, M.D.
Sponsor class: INDIV
Collaborators: name: Alexion Pharmaceuticals, Inc.
First posted: 2011-07-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Weight \> 40 kg
* Male or Female
* Recipients of first deceased donor kidneys
* 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)
* Novartis Delayed Graft Function Score 3-8
* Extended criteria donor with brain death, or standard criteria donor with cold ischemic time \< 24 hours

Exclusion Criteria:

* Planned to receive multi-organ transplant
* Kidneys from donors \< 6 years of age
* Dual kidney transplant (from same donor, including en bloc)
* Living donor kidney
* Highly sensitized recipients (PRA \> 50%)
* Previous transplant
* Participation in another investigational trial
* Recipient BMI \> 40
* ABO incompatible
* DCD Donor
* Preemptive kidney transplant
* Recipients with DGF scores \< 3 or \> 8
* Women who are pregnant or breast feeding
* Women of child bearing potential who are unable or unwilling to use a medically acceptable form of contraception
* Patients infected with HIV, HCV or HBV
* Active bacterial or other infection which is clinically significant in the opinion of the investigator
* Patients with history of splenectomy
* Patients with history of meningococcal disease
* Patients with known or suspected hereditary complement deficiency
* Patients with history of cancer (other than non-melanoma skin cancers) within the last 5 years

Primary outcomes:
measure: Composite of Delayed Graft Function and Slow Graft Function
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Recanati/Miller Transplantation Institute
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Bernd Schroppel, MD
role: PRINCIPAL_INVESTIGATOR
References: