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

NCT05758896 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • Contrast Induced Acute Kidney Injury

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

Sponsors & Collaborators

  • Aptabio Therapeutics, Inc.

    lead INDIV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-27
Primary Completion
2026-07-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05758896 on ClinicalTrials.gov