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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Schroppel, Bernd, M.D.
Sponsor:
Collaborator:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Schroppel, Bernd, M.D.
ClinicalTrials.gov Identifier:
NCT01403389
First received: July 25, 2011
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Delayed Function of Renal Transplant
Drug: Eculizumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Schroppel, Bernd, M.D.:

Primary Outcome Measures:
  • Composite of Delayed Graft Function and Slow Graft Function [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403389

Contacts
Contact: Bernd Schroppel, MD 212-659-8086 Bernd.Schroppel@mountsinai.org
Contact: Brandy Haydel, CCRC 212-241-0255 Brandy.Haydel@mountsinai.org

Locations
United States, New York
Mount Sinai Recanati/Miller Transplantation Institute Recruiting
New York, New York, United States, 10029
Contact: Bernd Schroppel, MD    212-659-8086    Bernd.Schroppel@mountsinai.org   
Contact: Brandy Haydel, CCRC    212-241-0255    Brandy.Haydel@mountsinai.org   
Principal Investigator: Bernd Schroppel, MD         
Sub-Investigator: Peter Heeger, MD         
Sponsors and Collaborators
Schroppel, Bernd, M.D.
Alexion Pharmaceuticals
Investigators
Principal Investigator: Bernd Schroppel, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Schroppel, Bernd, M.D.
ClinicalTrials.gov Identifier: NCT01403389     History of Changes
Other Study ID Numbers: HSM 10-1600
Study First Received: July 25, 2011
Last Updated: January 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Schroppel, Bernd, M.D.:
Kidney Transplant
Delayed Graft Function

Additional relevant MeSH terms:
Delayed Graft Function
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014