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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02490202
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : October 27, 2016
Information provided by (Responsible Party):
Prolong Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Delayed Function of Renal Transplant Drug: SANGUINATE Drug: Normal Saline Phase 2 Phase 3

Detailed Description:

Phase 2: Sixty (60) adult subjects who will be recipients of a donation after brain death (DBD) donor kidney and who meet all eligibility criteria will be randomized 1:1 within 48 hours prior to transplant surgery to receive: two infusions of SANGUINATE at a dose of 320 mg/kg or placebo on the day of surgery and approximately 24 hours after surgery. Patients will be hospitalized for up to 5 days and the study duration will be 30 days. Results will be used to inform the study design characteristics for Phase III, including sample size.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Prospective, Double-blind, Multicenter Phase 2/3 Study of the Efficacy and Safety of SANGUINATE™ for Reduction of Delayed Graft Function in Recipients of a Donation After Brain Death Kidney Transplant
Study Start Date : August 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SANGUINATE
Two (2) infusions of SANGUINATE
Two (2) infusions of 320 mg/kg of SANGUINATE at Baseline and Day 1
Other Name: pegylated carboxyhemoglobin bovine

Placebo Comparator: Normal Saline
Two (2) infusions of Normal Saline
Drug: Normal Saline
Two (2) infusions of Normal Saline at an equal volume to SANGUINATE at Baseline and Day 1.

Primary Outcome Measures :
  1. Reduction of delayed graft function (DGF) [ Time Frame: 30 Days ]
    Reduction of delayed draft function will be measured by the number of dialysis sessions.

  2. Participants With at Least One Occurrence of Safety Composite Endpoint by Treatment Group [ Time Frame: Phase 2 - 30 Days; Phase 3: Safety - 90 days; Serious Adverse Events and Adverse Events of Special Interest - 180 Days; Graft Survival - 365 Days ]
    Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, graft loss, death and other reported adverse events

Secondary Outcome Measures :
  1. Proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant [ Time Frame: 7 Days ]
  2. Proportion of subjects requiring dialysis only in the first 5 days post-transplant [ Time Frame: 5 Days ]
  3. Number of days of dialysis therapy. [ Time Frame: 30 Days ]
  4. Proportion of subjects with a fall in serum creatinine. [ Time Frame: 7 Days ]
  5. Proportion of subjects with a serum creatinine greater than 3 mg/dL, but who did not require dialysis by Day 5 post-transplant [ Time Frame: 5 Days ]
  6. Rate of change in estimated creatinine clearance and estimated glomerular filtration rate over time [ Time Frame: Phase 2: 30 Days ]

Other Outcome Measures:
  1. Determination of sample size for Phase 3 based upon the results from Phase 2. [ Time Frame: 30 Days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Able to understand and provide written informed consent.
  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:

  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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02490202

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Sponsors and Collaborators
Prolong Pharmaceuticals
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Study Director: Hemant Misra, PhD Prolong Pharmaceuticals
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Responsible Party: Prolong Pharmaceuticals Identifier: NCT02490202    
Other Study ID Numbers: SGTP-002
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Delayed Graft Function
Pathologic Processes