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NCT05758896 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Contrast Induced Acute Kidney Injury, sponsored by Aptabio Therapeutics.

Recruiting
Registry status
Phase 2
Development phase
280
Enrollment target
14
Study locations

NCT05758896: Recruiting Phase 2 study of Contrast Induced Acute Kidney Injury, sponsored by Aptabio Therapeutics.

NCT05758896 is a Phase 2 study of Contrast Induced Acute Kidney Injury that is actively recruiting participants, run by Aptabio Therapeutics. The registered enrollment target is 280 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (111% higher). The trial reports 14 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05758896, a Phase 2 study of Contrast Induced Acute Kidney Injury, is actively recruiting participants, sponsored by Aptabio Therapeutics.

RECRUITING
Registry status
Phase 2
Development phase
280 participants
Enrollment target
14
Study locations

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

Primary Outcome

Number of adverse events

Interventions

  • DRUG Placebo
  • DRUG Isuzinaxib (APX-115)

Study Locations (14)

Other

  • Kangwon National University Hospital - Chuncheon
  • Keimyung University Dongsan Hospital - Daegu
  • Chungnam National University Hospital - Daejeon
  • Inje University Ilsan Paik Hospital - Goyang
  • Chonnam National University Hospital - Gwangju
  • Seoul National University Bundang Hospital - Seongnam-si
  • Kangbuk Samsung Hospital - Seoul
  • Korea University Anam Hospital - Seoul
  • Samsung Medical Center - Seoul
  • Seoul National University Hospital - Seoul
  • The Catholic University of Korea Seoul St. Mary's Hospital - Seoul
  • The Catholic University of Korea St. Vincent's Hospital - Suwon
  • Ulsan University Hospital - Ulsan

Texas

  • Baylor Scott & White Research Institute - Dallas

Trial Details

FieldValue
Enrollment Target 280 participants
Start Date 2023-12-27
Est. Completion 2026-12-31
Phase Phase 2
Aptabio Therapeutics

3 total trials

What NCT05758896 shows while recruiting

NCT05758896 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (111% higher).

The record links to 1 condition, with Contrast Induced Acute Kidney Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05758896 lists 14 locations in 2 states (Other, Texas).

Frequently Asked Questions

What is clinical trial NCT05758896 about?

NCT05758896 is a clinical study titled "Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI". 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 random...

What is the current status of trial NCT05758896?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 280 participants. The study started on 2023-12-27. Estimated completion is 2026-12-31.

What conditions does trial NCT05758896 study?

This clinical trial studies the following conditions: Contrast Induced Acute Kidney Injury.

What interventions are being tested in trial NCT05758896?

The interventions under investigation include: Placebo (DRUG), Isuzinaxib (APX-115) (DRUG).

Who is sponsoring clinical trial NCT05758896?

This trial is sponsored by Aptabio Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05758896 being conducted?

This trial has 14 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Contrast Induced Acute Kidney Injury

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05758896's enrollment target sits among peer trials

280 196th of 2000 higher than 1,801 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05758896, the US trial registry maintained by the National Library of Medicine. NCT05758896 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.