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A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant

Sponsor
Schroppel, Bernd, M.D. (Other)
Overall Status
Terminated
CT.gov ID
NCT01403389
Collaborator
Alexion Pharmaceuticals (Industry)
8
Enrollment
1
Location
2
Arms
26.2
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Pilot Study of the Clinical Activity of Eculizumab for Prevention of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation
Actual Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Aug 6, 2013
Actual Study Completion Date :
Feb 6, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Eculizumab

Drug: Eculizumab
1200 milligrams Eculizumab diluted in 0.9% NaCl to 5mg/mL for a total volume of 240 mL administered by IV infusion over 35 minutes in the operating room prior to organ reperfusion
Other Names:
  • Soliris

    		•
    Placebo Comparator: 0.9% Sodium Chloride

    Drug: Placebo
    240 mL of 0.9% Sodium Chloride IV fluid given as placebo in the operating room prior to organ reperfusion
    Other Names:
  • 0.9% Sodium Chloride

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Composite of Delayed Graft Function and Slow Graft Function [Up to 6 months]

      Delayed Graft Function defined as follows: A need for at least one dialysis treatment during the first 7 days after transplantation (not including a single session for hyperkalemia or hypervolemia in the first 48 hours) A less than or equal to 50% reduction in serum creatinine in the first 24 hours post-transplantation A serum creatinine reduction ratio < 30% at 48 hours post-transplantation Slow Graft Function Defined as Follows: A functioning graft at Day 5 Post-transplantation with a serum creatinine > 3 mg/dL and no need for dialysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mount Sinai Recanati/Miller Transplantation Institute New York New York United States 10029

    Sponsors and Collaborators

    • Schroppel, Bernd, M.D.
    • Alexion Pharmaceuticals

    Investigators

    • Principal Investigator: Bernd Schroppel, MD, Icahn School of Medicine at Mount Sinai

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Schroppel, Bernd, M.D.
    ClinicalTrials.gov Identifier:
    NCT01403389
    Other Study ID Numbers:
    • HSM 10-1600
    First Posted:
    Jul 27, 2011
    Last Update Posted:
    May 6, 2019
    Last Verified:
    May 1, 2019
    Keywords provided by Schroppel, Bernd, M.D.
    Kidney Transplant
    Delayed Graft Function
    Additional relevant MeSH terms:
    Delayed Graft Function
    Eculizumab

    Study Results

    No Results Posted as of May 6, 2019