NCT03510897

QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery

A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,043 (actual)
• Sponsor: Quark Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury 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 3 trial to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events in subjects at high risk for acute kidney injury following cardiac surgery. Subjects will be dosed with active drug or placebo after the completion of cardiovascular surgery.

Conditions

• Cardiac Surgery

Interventions

Type	Name	Description
DRUG	teprasiran	IV injection
DRUG	Placebo	isotonic saline

Timeline

• Start date: 2018-06-29
• Primary completion: 2020-10-14
• Completion: 2021-04-12
• First posted: 2018-04-27
• Last updated: 2021-07-16

Locations

104 sites across 11 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, New Zealand, Spain, United Kingdom

Regulatory

• FDA-regulated drug study