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A Study of THR-184 in Patients at Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI)

NCT01830920 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2017-04-20

Study results available
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Summary

The purpose of this study is to determine whether THR-184 when administered around the time of cardiac surgery that requires cardiopulmonary bypass can prevent or ameliorate the development of acute kidney injury.

Conditions

Interventions

DRUG

THR-184

THR-184 is a synthetic oligopeptide administered intravenously.

DRUG

Placebo

A normal saline solution identical in appearance to the active drug solution

Sponsors & Collaborators

  • Thrasos Innovation, Inc.

    lead INDUSTRY

Principal Investigators

  • Andreas Orfanos, MBBCh · Thrasos Innovation, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01830920 on ClinicalTrials.gov