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

Purpose

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.

Condition

  • Cardiac Surgery

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
QPI-1002 		QPI-1002 Injection, Single dose
  • Drug: teprasiran
    IV injection
    Other names:
    • QPI-1002
Placebo Comparator
Placebo 		isotonic saline
  • Drug: Placebo
    isotonic saline

More Details

Status
Terminated
Sponsor
Quark Pharmaceuticals

Study Contact

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.