NCT02658162

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Prolong Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Delayed Function of Renal Transplant

Interventions

Type	Name	Description
DRUG	SANGUINATE	Two (2) infusions of 320 mg/kg of SANGUINATE at Baseline and Day 1
DRUG	Normal Saline	Two (2) infusions of Normal Saline at an equal volume to SANGUINATE at Baseline and Day 1.

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-10-01
• Completion: 2018-12-01
• First posted: 2016-01-18
• Last updated: 2018-05-25