drugset / Trial / NCT05758896

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

NCT05758896 ↗

Phase 2 Active not recruiting 230 enrolled Aptabio Therapeutics, Inc.
RandomizedParallel-groupDouble-blindPrevention

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 230 patients will be randomized into the study in a 1:1 ratio to 400 mg APX-115 (Isuzinaxib hydrochloride) or placebo arm.

Timeline

Start
2023-12-27
Primary completion
2026-07-30
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Isuzinaxib Small molecule 400 mg Oral

Indications