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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01403389
Recruitment Status : Terminated (After interim analysis, the pilot study was terminated and modified to a larger multicenter study (NCT01919346) to better assess efficacy.)
First Posted : July 27, 2011
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Schroppel, Bernd, M.D.

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
Delayed Function of Renal Transplant Drug: Eculizumab Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
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 : December 1, 2011
Actual Primary Completion Date : August 6, 2013
Actual Study Completion Date : February 6, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Eculizumab

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 Name: 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 Name: 0.9% Sodium Chloride




Primary Outcome Measures :
  1. Composite of Delayed Graft Function and Slow Graft Function [ Time Frame: Up to 6 months ]

    Delayed Graft Function defined as follows:

    1. 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)
    2. A less than or equal to 50% reduction in serum creatinine in the first 24 hours post-transplantation
    3. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403389


Locations
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United States, New York
Mount Sinai Recanati/Miller Transplantation Institute
New York, New York, United States, 10029
Sponsors and Collaborators
Schroppel, Bernd, M.D.
Alexion Pharmaceuticals
Investigators
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Principal Investigator: Bernd Schroppel, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Schroppel, Bernd, M.D.
ClinicalTrials.gov Identifier: NCT01403389    
Other Study ID Numbers: HSM 10-1600
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Keywords provided by Schroppel, Bernd, M.D.:
Kidney Transplant
Delayed Graft Function
Additional relevant MeSH terms:
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Delayed Graft Function
Pathologic Processes