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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 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. The trial reports 14 study locations across 2 states.
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.
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, categorized as Phase 2. 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 3 total studies on file at ClinicalTrials.gov.
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 reports 14 study locations spanning 2 distinct geographic areas - top geographies include 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.
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