Efficacy and Safety of SANGUINATE™ for Reduction of Delayed Graft Function in Patients Receiving a Kidney Transplant
NCT ID: NCT02490202
Last Updated: 2016-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2015-08-31
2016-10-31
Brief Summary
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Detailed Description
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Phase III: The same inclusion/exclusion requirements, dosing schedule, hospitalization stay and outpatient visits as in Phase II with additional visits scheduled at Day 90, Day 180 and Day 365. Study duration will be 365 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SANGUINATE
Two (2) infusions of SANGUINATE
SANGUINATE
Two (2) infusions of 320 mg/kg of SANGUINATE at Baseline and Day 1
Normal Saline
Two (2) infusions of Normal Saline
Normal Saline
Two (2) infusions of Normal Saline at an equal volume to SANGUINATE at Baseline and Day 1.
Interventions
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SANGUINATE
Two (2) infusions of 320 mg/kg of SANGUINATE at Baseline and Day 1
Normal Saline
Two (2) infusions of Normal Saline at an equal volume to SANGUINATE at Baseline and Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female subject at least 18 years of age.
3. Dialysis-dependent renal failure initiated at least 3 months prior to transplantation.
4. Subject is to be the recipient of a first kidney transplant from a deceased donor (brain death criteria).
5. Is able to receive intravenous infusions of study drug.
6. Anticipated donor organ cold ischemia time \< 30 hours.
7. A calculated prediction of DGF risk of least 25%.
8. Females of childbearing potential must agree to use 2 forms of effective birth control regimen (at least one-barrier method) during the initial 30-day study period.
9. Male subjects must agree to use condoms or other suitable means of pregnancy prevention.
Exclusion Criteria
2. Recipient of a live donor kidney or a kidney from a donation after cardiac death (DCD) donor.
3. Recipient of donor kidney preserved with normothermic machine perfusion.
4. Is scheduled to undergo multi-organ transplantation.
5. Has planned transplant of kidney(s) from a donor \< 6 years of age.
6. Has planned transplant of kidneys that are implanted en bloc (dual kidney transplant).
7. Has planned transplant of dual kidneys (from the same donor) transplanted not en bloc.
8. Body Mass Index (BMI) \> 38 kg/m2
9. Is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy (under another Investigational New Drug) for ischemic/reperfusion injury immediately prior to organ recovery.
10. Is scheduled to receive an blood type-incompatible donor kidney.
11. Has undergone desensitization to remove antibodies prior to transplantation.
12. Total bilirubin \> 1.5 mg per dL, transaminase more than twice the upper limit of normal or evidence of hepatic insufficiency
13. Has participated in an investigational study within the last 30 days or received an investigational product within 5 half-lives of the study drug administration, whichever is longest. Potential subjects participating in a strictly observational study or a study involving approved treatments should be discussed with the Medical Monitor.
14. Has a history of human immunodeficiency virus (HIV)
15. History or presence of active substance abuse (illicit drugs or alcohol) in the previous 6 months, as believed by the Investigator
16. Presence of ECG-based evidence of acute myocardial infarction, unstable angina, decompensated heart failure, third degree heart block or cardiac arrhythmia associated with hemodynamic instability
17. History or presence of any disease or psychiatric condition that in the Investigator's assessment that would increase the risk to subjects associated with study participation, drug administration or interpretation of results
18. History of biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ skin lesions, carcinoma of the cervix in situ, or early detected prostate cancer.
19. Female subject who is pregnant or breast feeding.
18 Years
ALL
No
Sponsors
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Prolong Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Hemant Misra, PhD
Role: STUDY_DIRECTOR
Prolong Pharmaceuticals
Locations
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Mayo Clinic Phoenix
Phoenix, Arizona, United States
University of California, Los Angeles
Los Angeles, California, United States
California Institute of Renal Research
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
Medstar Georgetown University Hosiptal
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
Augusta University
Augusta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
UIC University of Illinois at Chicago
Chicago, Illinois, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
The Cleveland Clinic
Cleveland, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Central Pennsylvania Transplant Foundation
Harrisburg, Pennsylvania, United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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SGTP-002
Identifier Type: -
Identifier Source: org_study_id