Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI (NCT05758896) | Clinical Trial Compass
RecruitingPhase 2
Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI
United States, South Korea280 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 280 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 range18 Years
SexALL
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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.
✓. Risk of CKD evidenced by 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.
✓. 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
✕. ESRD confirmed by eGFR \< 15 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.