Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

Cardiac Surgery MAKE AKI teprasiran QPI-1002

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male or female, age ≥ 18 years old
  • At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors:
  • Reduced renal function
  • Diabetes with ongoing insulin treatment
  • Albuminuria
  • Undergoes non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest

You CAN'T join if...

  • Emergent surgeries, including aortic dissection, and major congenital heart defects
  • Undergoes cardiac surgery off CPB for subjects ≥45 years old. (Cardiac surgery off CPB for subjects <45 years old is allowed.)
  • Perioperative or post cardiac surgery, an left ventricular assist device (LVAD) is inserted or anticipated

Locations

  • Ronald Regan UCLA Medical Center
    Los Angeles California 90095 United States
  • Cedar-Sinai Heart Institute
    Los Angeles California 90048 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Quark Pharmaceuticals
ID
NCT03510897
Phase
Phase 3
Study Type
Interventional
Last Updated