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

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ClinicalTrials.gov Identifier: NCT02490202
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : October 27, 2016
Sponsor:
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
Drug: 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

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

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 ClinicalTrials.gov identifier (NCT number): NCT02490202


Locations
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United States, Arizona
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85054
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90024
California Institute of Renal Research
San Diego, California, United States, 92123
California Pacific Medical Center
San Francisco, California, United States, 94115
University of California San Francisco
San Francisco, California, United States, 94143
United States, District of Columbia
Medstar Georgetown University Hosiptal
Washington, District of Columbia, United States, 20007
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Augusta University
Augusta, Georgia, United States, 30912
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
UIC University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48212
United States, New Jersey
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
University of Toledo
Toledo, Ohio, United States, 43537
United States, Pennsylvania
Central Pennsylvania Transplant Foundation
Harrisburg, Pennsylvania, United States, 17104
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
Prolong Pharmaceuticals
Investigators
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Study Director: Hemant Misra, PhD Prolong Pharmaceuticals

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Responsible Party: Prolong Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02490202     History of Changes
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