Efficacy and Safety of SANGUINATE™ for Reduction of Delayed Graft Function in Patients Receiving a Kidney Transplant

Completed · Phase 2/Phase 3

Conditions studied: Delayed Function of Renal Transplant

In brief

Safety and efficacy study of SANGUINATE on reduction of delayed graft function (DGF) in patients who will be recipients of a donation after brain death (DBD) donor kidney.

Key facts

Study ID

NCT02490202

Run by

Prolong Pharmaceuticals

People needed

60

Starts

2015-08-01

Expected to finish

2016-10-01

Last updated by the study team

2016-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to understand and provide written informed consent.
• Male or female subject at least 18 years of age.
• Dialysis-dependent renal failure initiated at least 3 months prior to transplantation.
• Subject is to be the recipient of a first kidney transplant from a deceased donor (brain death criteria).
• Is able to receive intravenous infusions of study drug.
• Anticipated donor organ cold ischemia time < 30 hours.
• A calculated prediction of DGF risk of least 25%.
• 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.
• Male subjects must agree to use condoms or other suitable means of pregnancy prevention.

You may not qualify if…

• Has received a blood transfusion of packed red blood cells (PRBC), other than with leukocyte-poor blood, within the 90-day period prior to screening.
• Recipient of a live donor kidney or a kidney from a donation after cardiac death (DCD) donor.
• Recipient of donor kidney preserved with normothermic machine perfusion.
• Is scheduled to undergo multi-organ transplantation.
• Has planned transplant of kidney(s) from a donor < 6 years of age.
• Has planned transplant of kidneys that are implanted en bloc (dual kidney transplant).
• Has planned transplant of dual kidneys (from the same donor) transplanted not en bloc.
• Body Mass Index (BMI) > 38 kg/m2
• 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.
• Is scheduled to receive an blood type-incompatible donor kidney.
• Has undergone desensitization to remove antibodies prior to transplantation.
• Total bilirubin > 1.5 mg per dL, transaminase more than twice the upper limit of normal or evidence of hepatic insufficiency
• 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.
• Has a history of human immunodeficiency virus (HIV)
• History or presence of active substance abuse (illicit drugs or alcohol) in the previous 6 months, as believed by the Investigator
• 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
• 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
• 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.
• Female subject who is pregnant or breast feeding.

Where it is running

• 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

Full record on ClinicalTrials.gov

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