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Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI
NCT05758896 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2023-12-27 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05758896
The ClinicalTrials.gov registry entry for NCT05758896 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aptabio Therapeutics, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05758896 reports 14 study locations spanning 2 distinct geographic areas — top geographies include Other, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05758896?
The interventions under investigation include: Placebo (DRUG), Isuzinaxib (APX-115) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05758896?
This trial is sponsored by Aptabio Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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