Status:
TERMINATED
A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant
Lead Sponsor:
Schroppel, Bernd, M.D.
Collaborating Sponsors:
Alexion Pharmaceuticals, Inc.
Conditions:
Delayed Function of Renal Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01403389
Start Date
December 1 2011
End Date
February 6 2014
Last Update
May 6 2019
Active Locations (1)
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1
Mount Sinai Recanati/Miller Transplantation Institute
New York, New York, United States, 10029