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

Study Type: Interventional Estimated Enrollment: 1088 participants, global (approximately 1038 subjects who are 45 years old and above, with a target of 519 per treatment group, who have undergone non-emergent cardiac surgery and are at risk of developing AKI, who meet the Inclusion and none of the Exclusion Criteria, will be randomized at approximately 110 global study centers and included in the primary efficacy analysis. In addition , up to 50 adult subjects 18-<45 years old may be randomized but will not be included in the primary efficacy analysis.) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Official Title: 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 Primary Outcome Measures: Proportion of subjects through day 90 who develop major adverse kidney events [Time Frame: Baseline through day 5] Secondary Outcome Measures: 1. Proportion of subjects developing AKI overall by modified AKIN criteria within 5 days post-surgery {Time Frame: Baseline through day 5] 2. renal function as estimated by glomerular filtration rate [Time Frame: Baseline through Day 90] 3. Proportion of subjects who die or initiate dialysis through day 90 [Time Frame: Baseline through day 90]

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