Effect on Contrast Induced Acute Kidney Injury of APX-115 in Subjects Undergoing Percutaneous Coronary Intervention A Randomized, Double-blind, Parallel Group, Multicenter, Multi-national Trial
This phase 2 study is to assess the safety and efficacy of APX-115 active doses in Contrast Induced Acute Kidney Disease compared to placebo following multiple oral dosing in patients with undergoing percutaneous coronary intervention. It is anticipated that approximately 280 patients will be randomized into the study in a 1:1 ratio to 400 mg APX-115 (Isuzinaxib hydrochloride) or placebo arm.
• Willing and able to provide informed consent.
• Male or female, of any race or ethnicity, 18 years of age or older, inclusive, on the day of informed consent. Racial and ethnic minorities should be included in the study population to the greatest extent possible.
• Diagnosed with coronary artery disease.
• Planned to undergo coronary angiography within 4 weeks of being consented.
• Risk of CKD evidenced by 30 mL/min/1.73m2 ≤ eGFR (Glomerular filtration rate) \< 90 mL/min/1.73 m2 confirmed by local or central laboratory.
• Women of childbearing potential or males willing and able to use at least one protocol-specified method of contraception for the duration of their enrolment.
• Subject is aware of the investigational nature of this study and willing to comply with protocol treatments, blood tests, and other evaluations listed in the ICF.