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A Study on SANGUINATE™ for the Reduction of Delayed Graft Function in Kidney Transplant Patients | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

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

NCT02658162•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

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.

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. 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.
+12 more criteria

Key Dates

Start Date

February 1, 2016

Primary Completion Date

October 1, 2018

Completion Date

December 1, 2018

Last Updated

May 25, 2018

Conditions

Delayed Function of Renal Transplant

Interventions

SANGUINATE

DRUG

Normal Saline

DRUG

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

NCT01513707

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

View study

COMPLETEDPHASE2/PHASE3

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

NCT02490202

Delayed Function of Renal Transplant

View study

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: May 25, 2018Data 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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