QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery
- Registration Number
- NCT03510897
- Lead Sponsor
- Quark Pharmaceuticals
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1043
-
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
Key
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo isotonic saline QPI-1002 teprasiran QPI-1002 Injection, Single dose
- Primary Outcome Measures
Name Time Method Proportion of subjects through day 90 who develop major adverse kidney events Baseline through day 90
- Secondary Outcome Measures
Name Time Method Proportion of subjects who die or initiate dialysis through day 90 Baseline through day 90 Proportion of subjects developing AKI overall by modified AKIN criteria within 5 days post-surgery Baseline through day 5 Renal function as estimated by glomerular filtration rate Baseline through Day 90
Trial Locations
- Locations (104)
University of Alabama at Birmingham Hospital
🇺🇸Birmingham, Alabama, United States
Keck Hospital of USC
🇺🇸Los Angeles, California, United States
Cedar-Sinai Heart Institute
🇺🇸Los Angeles, California, United States
Ronald Regan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
River City Clinical Research
🇺🇸Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Emory Saint Joseph's Hospital
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Indiana/ Ohio Heart, a division of Luthern Medical Group, LLC
🇺🇸Fort Wayne, Indiana, United States
Scroll for more (94 remaining)University of Alabama at Birmingham Hospital🇺🇸Birmingham, Alabama, United States