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Efficacy and Safety of SANGUINATE™ for Reduction of Delayed Graft Function in Patients Receiving a Kidney Transplant | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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

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

NCT02490202•Prolong Pharmaceuticals

View on ClinicalTrials.gov

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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. 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.
+9 more criteria

Locations (20)

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

Key Dates

Start Date

August 1, 2015

Primary Completion Date

August 1, 2016

Completion Date

October 1, 2016

Last Updated

October 27, 2016

Enrollment

ACTUAL participants

Conditions

Delayed Function of Renal Transplant

Interventions

SANGUINATE

DRUG

Normal Saline

DRUG

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

NCT02658162

Delayed Function of Renal Transplant

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UNKNOWN

The Effects of Pre-transplant Dialysis Modality on Post-transplant Events

NCT01513707

Delayed Function of Renal TransplantPrimary Nonfunction of Renal Transplant+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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