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RECRUITING
NCT05758896
PHASE2

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

Sponsor: Aptabio Therapeutics, Inc.

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 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

Interventions

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

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