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Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI
Sponsor: Aptabio Therapeutics, Inc.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2023-12-27
Completion Date
2026-12-31
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Isuzinaxib (APX-115)
Treatment allocation in 1:1 ratio to Isuzinaxib or Placebo
Placebo
Treatment allocation in 1:1 ratio to Isuzinaxib or Placebo
Locations (14)
Baylor Scott & White Research Institute
Dallas, Texas, United States
Kangwon National University Hospital
Chuncheon, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Inje University Ilsan Paik Hospital
Goyang, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, South Korea
Ulsan University Hospital
Ulsan, South Korea