Eculizumab for Prevention of Delayed Graft Function (DGF) in Kidney Transplantation



Status:Active, not recruiting
Conditions:Other Indications, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:18 - Any
Updated:2/24/2017
Start Date:August 2013
End Date:December 2018

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Eculizumab for Prevention of Delayed Graft Function in Deceased Donor Kidney Transplantation

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.


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:

1. 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

2. Standard Criteria Donor (SCD) kidney with actual cold ischemia time (CIT) 18 -
40 hours

Exclusion Criteria:

- 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.
We found this trial at
5
sites
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Sanjay Kulkarni, MD
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Haven, CT
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Roy Bloom, MD
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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Cleveland, Ohio 44194
Principal Investigator: Donald Hricik, MD
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Cleveland, OH
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Peter S Heeger, MD
Phone: 212-241-6324
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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New York, NY
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New York, New York 10467
Principal Investigator: Enver Akalin, MD
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New York, NY
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