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
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
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.
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.
Key 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:
Undergoes non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest
Key Exclusion Criteria:
Fort Wayne, Indiana 46804, United States
Greenville, North Carolina 27834, United States
Dallas, Texas 75246, United States
Calgary, Alberta T2N 2T9, Canada
Edmonton, Alberta TG6 2B7, Canada
Québec, Quebec G1V4G5, Canada
Prague, 140 21, Czechia
Prague, 15006, Czechia
Strasbourg, 67091, France
Berlin, Brandenburg 13353, Germany
Geißen, Hesse 35392, Germany
Dresden, 01307, Germany