Status:
TERMINATED
Eculizumab for Prevention of Delayed Graft Function (DGF) in Kidney Transplantation
Lead Sponsor:
Heeger, Peter, M.D.
Collaborating Sponsors:
Alexion Pharmaceuticals, Inc.
Icahn School of Medicine at Mount Sinai
Conditions:
Delayed Graft Function
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 supporti...
Eligibility Criteria
Inclusion
- 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:
- Extended Criteria Donor (ECD) kidney with brain death: Kidney donors 60 years of age or older; or donors aged 50-59 years and have two of the following features: Hypertension, terminal serum creatinine \> 1.5 mg/dL, or death from cerebrovascular accident (CVA), OR
- Standard Criteria Donor (SCD) kidney with actual cold ischemia time (CIT) 18 - 40 hours
Exclusion
- Patient is planned to receive a multi-organ transplant
- Kidney from donor \< 6 years of age
- Dual kidney transplant (from same donor, including en bloc)
- Living donor kidney transplant
- Recipients with donor-specific anti-HLA antibodies of more than 3,000 MFI
- Participation in another investigational drug study
- Recipient BMI \> 40
- ABO incompatible
- DCD (donor with cardiac death) Donor
- 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 (defined as the use of oral, injected or implanted hormonal methods of contraception, intrauterine device (IUD)or intrauterine system (IUS), barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository)
- Patients with HBsAg-positive status, HCV infection, or HIV infection
- Patients with atypical hemolytic uremic syndrome (aHUS) or C3 glomerulonephritis (C3GN)
- 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 allergic to or unable to tolerate Ciprofloxacin
- Patients unable or unwilling to receive vaccination against meningitis prior to study drug administration
- Patients with a known or suspected hereditary complement deficiency
- Patients with a history of cancer (other than non melanoma skin cancers) within the last five years
- Donors of more than 70 years of age
- Subjects with a psychiatric or physical illness which in the opinion of the Investigator would interfere with their ability to participate in the study.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01919346
Start Date
August 1 2013
End Date
December 1 2017
Last Update
February 27 2018
Active Locations (5)
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1
Yale - New Haven Hospital
New Haven, Connecticut, United States, 06540
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
3
Montefiore Medical Center
New York, New York, United States, 10467
4
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106