NCT05758896

Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Aptabio Therapeutics, Inc. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with chronic kidney disease undergoing percutaneous coronary intervention deserve careful consideration of various clinical options to minimize the risk of contrast-induced acute kidney injury and to optimize clinical outcomes. Contrast-induced acute kidney injury (CI-AKI) is a leading cause of a hospital-acquired renal failure and has been reported to affect both the mortality and morbidity of patients receiving contrast media. Contrast-induced acute kidney injury is the third leading cause of hospital-acquired acute kidney injury and has been recognized as a serious complication of percutaneous coronary intervention (PCI), which may be associated with increased morbidity and mortality. APX-115 is a potent small molecule inhibitor of NADPH-oxidase (NOX) isozymes developed by AptaBio Therapeutics, Inc. In-vivo study results suggest that multiple NOX isoforms may contribute to renal injury in CI-AKI model, and pan-NOX inhibition may be a new therapeutic approach for prevention of CI-AKI.

Conditions

• Contrast Induced Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	Isuzinaxib (APX-115)	Treatment allocation in 1:1 ratio to Isuzinaxib or Placebo
DRUG	Placebo	Treatment allocation in 1:1 ratio to Isuzinaxib or Placebo

Timeline

• Start date: 2023-12-27
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2023-03-08
• Last updated: 2026-02-27

Locations

14 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study