NCT02610283

A Study to Evaluate Efficacy and Safety of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery

A Randomized, Double-Blind, Placebo Controlled , Phase 2 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Acute Kidney Injury in Subjects at High Risk for AKI Following Cardiac Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 341 (actual)
• Sponsor: Quark Pharmaceuticals · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

This trial is designed to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.

Detailed description

This is a randomized, double-blind, placebo-controlled, Phase 2 trial to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	QPI-1002	IV injection
DRUG	Placebo	isotonic saline

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-02-01
• Completion: 2018-04-01
• First posted: 2015-11-20
• Last updated: 2019-01-10

Locations

36 sites across 3 countries: United States, Canada, Germany