This trial is designed to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.
This is a randomized, double-blind, placebo-controlled, Phase 2 trial to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
341
Proportion of subjects developing AKI as defined by the AKIN criteria
Time frame: Baseline through Day 5
Proportion of subjects developing at least on of the following events: death, needing renal replacement therapy (RRT) during the 90-day post-operative period, or having a ≥ 25% reduction in SCr based eGFR at the Day 90 visit
Time frame: Baseline through Day 90
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University of Arizona Sarver Heart Center
Tucson, Arizona, United States
University of Florida
Gainesville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
River City Clinical Research
Jacksonville, Florida, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Indiana Ohio Heart
Fort Wayne, Indiana, United States
St. Vincent Medical Group
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
Mid Michigan Cardiovascular Research
Midland, Michigan, United States
...and 26 more locations