Clinical Trial

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

Completed Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 changes
critical Trial completed 2026-08-07
minor Completion moved earlier: 2026-12-31 -> 2026-07-22 2026-08-07
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-21
notable Enrollment reduced: 280 -> 230 participants 2026-05-21
notable Primary completion moved earlier: 2026-09-30 -> 2026-07-30 2026-05-21
Trial Details
NCT Number NCT05758896
Lead Sponsor Aptabio Therapeutics, Inc.
Conditions Contrast Induced Acute Kidney Injury
Enrollment 218 participants
Start Date 2023-12-27
Primary Completion 2026-07-22 (estimated)
Study Completion 2026-07-22 (estimated)
Updated on ClinicalTrials.gov 2026-08-06