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
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator QPI-1002 |
QPI-1002 Injection, Single dose |
|
Placebo Comparator 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.