A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant
Primary Purpose
Delayed Function of Renal Transplant
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Eculizumab
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Delayed Function of Renal Transplant focused on measuring Kidney Transplant, Delayed Graft Function
Eligibility 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
Sites / Locations
- Mount Sinai Recanati/Miller Transplantation Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Eculizumab
0.9% Sodium Chloride
Arm Description
Outcomes
Primary Outcome Measures
Composite of Delayed Graft Function and Slow Graft Function
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01403389
First Posted
July 25, 2011
Last Updated
May 2, 2019
Sponsor
Schroppel, Bernd, M.D.
Collaborators
Alexion
1. Study Identification
Unique Protocol Identification Number
NCT01403389
Brief Title
A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant
Official Title
Pilot Study of the Clinical Activity of Eculizumab for Prevention of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
After interim analysis, the pilot study was terminated and modified to a larger multicenter study (NCT01919346) to better assess efficacy.
Study Start Date
December 1, 2011 (Actual)
Primary Completion Date
August 6, 2013 (Actual)
Study Completion Date
February 6, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schroppel, Bernd, M.D.
Collaborators
Alexion
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Function of Renal Transplant
Keywords
Kidney Transplant, Delayed Graft Function
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eculizumab
Arm Type
Experimental
Arm Title
0.9% Sodium Chloride
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Eculizumab
Other Intervention Name(s)
Soliris
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% Sodium Chloride
Intervention Description
240 mL of 0.9% Sodium Chloride IV fluid given as placebo in the operating room prior to organ reperfusion
Primary Outcome Measure Information:
Title
Composite of Delayed Graft Function and Slow Graft Function
Description
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
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Schroppel, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Recanati/Miller Transplantation Institute
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant
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