Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI (NCT05758896) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI
United States, South Korea230 participantsStarted 2023-12-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Willing and able to provide informed consent.
. Male or female, of any race or ethnicity, 18 years of age or older, inclusive, on the day of informed consent. Racial and ethnic minorities should be included in the study population to the greatest extent possible.
. Diagnosed with coronary artery disease.
. Planned to undergo coronary angiography within 4 weeks of being consented.
. 30 mL/min/1.73m2 ≤ eGFR (Glomerular filtration rate) \< 90 mL/min/1.73 m2 confirmed by local or central laboratory.
. Women of childbearing potential or males willing and able to use at least one protocol-specified method of contraception for the duration of their enrolment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subject is aware of the investigational nature of this study and willing to comply with protocol treatments, blood tests, and other evaluations listed in the ICF.
Exclusion criteria
. Females who are pregnant or who are planning to become pregnant before the end of planned enrolment or who are breastfeeding.
. Subjects who are not expected to go through PCI at the discretion of investigator or cardiologist
. Subjects who have a history of hypersensitivity to contrast media or who cannot be administered contrast media according to investigator's discretion
. Acute myocardial infarction within 1 month prior to Screening
. CKD stage 4 and 5 confirmed by eGFR \< 30 mL/min/1.73 m2 at Screening.
. Clinically significant heart disease as determined by the Investigator within 2 months prior to Screening including but not limited to any of following; cardiogenic shock, treatment requiring intra-aortic balloon pump (IABP) support, treatment with extra corporeal membrane oxygenation (ECMO), or NYHA class IV heart failure.
. Uncontrolled treated/untreated hypertension (defined as systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg, mean of measured 2 times at Screening will be permitted).
. Known or suspected hypersensitivity to any component of the APX-115 formulation.