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

NCT02490202 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-10-27

No results posted yet for this study

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.

Conditions

  • Delayed Function of Renal Transplant

Interventions

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.

Sponsors & Collaborators

  • Prolong Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Hemant Misra, PhD · Prolong Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-08-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02490202 on ClinicalTrials.gov