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

Primary Purpose

Delayed Function of Renal Transplant

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SANGUINATE
Normal Saline
Sponsored by
Prolong Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delayed Function of Renal Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    SANGUINATE

    Normal Saline

    Arm Description

    Two (2) infusions of SANGUINATE

    Two (2) infusions of Normal Saline

    Outcomes

    Primary Outcome Measures

    Reduction of delayed graft function (DGF)
    Reduction of delayed draft function will be measured by the number of dialysis sessions.
    Participants With at Least One Occurrence of Safety Composite Endpoint by Treatment Group.
    Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, graft loss, death and other reported adverse events and Graft Survival - 30 Days

    Secondary Outcome Measures

    Proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant
    Proportion of subjects requiring dialysis only in the first 5 days post-transplant
    Number of days of dialysis therapy.
    Proportion of subjects with a fall in serum creatinine.
    Proportion of subjects with a serum creatinine greater than 3 mg/dL, but who did not require dialysis by Day 5 post-transplant
    Change in estimated creatinine clearance before and after kidney transplantation.
    Change in estimated glomerular filtration rate before and after kidney transplantation.

    Full Information

    First Posted
    January 12, 2016
    Last Updated
    May 23, 2018
    Sponsor
    Prolong Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02658162
    Brief Title
    A Study on SANGUINATE™ for the Reduction of Delayed Graft Function in Kidney Transplant Patients
    Official Title
    A Randomized, Placebo-controlled, Prospective, Single-blind, Single Center Phase 2 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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    February 2016 (Anticipated)
    Primary Completion Date
    October 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Prolong Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delayed Function of Renal Transplant

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SANGUINATE
    Arm Type
    Experimental
    Arm Description
    Two (2) infusions of SANGUINATE
    Arm Title
    Normal Saline
    Arm Type
    Placebo Comparator
    Arm Description
    Two (2) infusions of Normal Saline
    Intervention Type
    Drug
    Intervention Name(s)
    SANGUINATE
    Other Intervention Name(s)
    pegylated carboxyhemoglobin bovine
    Intervention Description
    Two (2) infusions of 320 mg/kg of SANGUINATE at Baseline and Day 1
    Intervention Type
    Drug
    Intervention Name(s)
    Normal Saline
    Intervention Description
    Two (2) infusions of Normal Saline at an equal volume to SANGUINATE at Baseline and Day 1.
    Primary Outcome Measure Information:
    Title
    Reduction of delayed graft function (DGF)
    Description
    Reduction of delayed draft function will be measured by the number of dialysis sessions.
    Time Frame
    30 Days
    Title
    Participants With at Least One Occurrence of Safety Composite Endpoint by Treatment Group.
    Description
    Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, graft loss, death and other reported adverse events and Graft Survival - 30 Days
    Time Frame
    30 Days
    Secondary Outcome Measure Information:
    Title
    Proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant
    Time Frame
    7 Days
    Title
    Proportion of subjects requiring dialysis only in the first 5 days post-transplant
    Time Frame
    5 Days
    Title
    Number of days of dialysis therapy.
    Time Frame
    30 Days
    Title
    Proportion of subjects with a fall in serum creatinine.
    Time Frame
    7 Days
    Title
    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
    Title
    Change in estimated creatinine clearance before and after kidney transplantation.
    Time Frame
    30 Days
    Title
    Change in estimated glomerular filtration rate before and after kidney transplantation.
    Time Frame
    30 Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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 Machine perfused preservation donor kidney. 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. Has a positive T- or B-cell cross-match by NIH anti-globulin lymphocytotoxicity method, if performed. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hemant Misra, PhD
    Organizational Affiliation
    Prolong Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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