A Study on SANGUINATE™ for the Reduction of Delayed Graft Function in Kidney Transplant Patients

Exclusion Criteria

• •1. 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.
• •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. Machine perfused preservation donor kidney.
• •10. 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.
• •11. Is scheduled to receive an blood type-incompatible donor kidney.
• •12. Has undergone desensitization to remove antibodies prior to transplantation.
• •13. Total bilirubin \> 1.5 mg per dL, transaminase more than twice the upper limit of normal or evidence of hepatic insufficiency
• •14. 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.
• •15. Has a history of human immunodeficiency virus (HIV)
• •16. History or presence of active substance abuse (illicit drugs or alcohol) in the previous 6 months, as believed by the Investigator
• •17. 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
• •18. 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
• •19. 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.
• •20. Female subject who is pregnant or breast feeding.
• •21. Has a positive T- or B-cell cross-match by NIH anti-globulin lymphocytotoxicity method, if performed.
• •22. Has a positive T- or B-cell cross-match AND donor specific anti-human leukocyte antigen (anti-HLA) antibody (DSA) detected by flow cytometry/Luminex based antigen-specific anti-HLA antibody testing, if performed.