Actively Recruiting
Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI
Led by Aptabio Therapeutics, Inc. · Updated on 2026-02-27
280
Participants Needed
14
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent.
- Male or female, of any race or ethnicity, 18 years of age or older.
- Diagnosed with coronary artery disease.
- Planned to undergo coronary angiography within 4 weeks of consent.
- Risk of chronic kidney disease with eGFR between 30 and 90 mL/min/1.73 m2.
- Women of childbearing potential or males willing and able to use at least one protocol-specified method of contraception during enrollment.
- Aware of the investigational nature of the study and willing to comply with protocol treatments and evaluations.
You will not qualify if you...
- Pregnant or breastfeeding females, or those planning pregnancy before study end.
- Not expected to undergo PCI as determined by investigator or cardiologist.
- History of hypersensitivity to contrast media or unable to receive contrast media.
- Acute myocardial infarction within 1 month before screening.
- End stage renal disease with eGFR less than 15 mL/min/1.73 m2.
- Clinically significant heart disease within 2 months before screening including cardiogenic shock, intra-aortic balloon pump, ECMO treatment, or NYHA class IV heart failure.
- Uncontrolled hypertension with systolic >180 mmHg or diastolic >100 mmHg.
- Known or suspected hypersensitivity to any component of APX-115.
- Acute kidney injury or dialysis within 1 month prior to screening or planned dialysis during enrollment.
- Clinically apparent liver disease or moderate/severe hepatic impairment at screening.
- Impaired liver function with ALT ≥ 2.5 times upper normal limit or total bilirubin >1.5 times upper normal limit unless known Gilbert's syndrome.
- Signs or symptoms of acute or chronic infection at screening.
- Use of any investigational drug within 4 weeks prior to screening.
- Confirmed or suspected alcohol or substance abuse within 1 year prior to screening.
- Significant hematology abnormalities below specified thresholds.
- Other significant medical conditions or lab abnormalities that may affect safety or compliance.
- Mental incapacity, unwillingness, or language barrier preventing cooperation with protocol.
- Use of certain enzyme substrates or inhibitors unless approved by medical monitor prior to dosing.
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Baylor Scott & White Research Institute
Dallas, Texas, United States, 75204
Actively Recruiting
2
Kangwon National University Hospital
Chuncheon, South Korea
Actively Recruiting
3
Keimyung University Dongsan Hospital
Daegu, South Korea
Actively Recruiting
4
Chungnam National University Hospital
Daejeon, South Korea
Actively Recruiting
5
Inje University Ilsan Paik Hospital
Goyang, South Korea
Actively Recruiting
6
Chonnam National University Hospital
Gwangju, South Korea
Actively Recruiting
7
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Actively Recruiting
8
Kangbuk Samsung Hospital
Seoul, South Korea
Actively Recruiting
9
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
10
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
11
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
12
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
13
The Catholic University of Korea St. Vincent's Hospital
Suwon, South Korea
Actively Recruiting
14
Ulsan University Hospital
Ulsan, South Korea
Actively Recruiting
Research Team
A
Aptabio Therapeutics Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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