CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 452 enrolled
Drug / intervention
THR-184 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01830920
NCT01830920Phase 2Completed

A Multi-Center, Parallel-Group, Randomized, Double Blind, Adaptive Study Investigating the Safety and Efficacy of THR-184 in Patients at Increased Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI)

Thrasos Innovation, Inc.·interventional·Posted Apr 12, 2013·Updated Apr 20, 2017

In Brief

A Phase 2 clinical trial evaluating THR-184 and Placebo for Acute Kidney Injury. Completed, enrolled 452 participants across 41 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 12, 2013
Enrollment StartMay 1, 2013
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.2 years ago

Interventions

THR-184drug

THR-184 is a synthetic oligopeptide administered intravenously.

Placebodrug

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