Effect on Contrast Induced Acute Kidney Injury of APX-115 in Subjects Undergoing Percutaneous Coronary Intervention A Randomized, Double-blind, Parallel Group, Multicenter, Multi-national Trial
Aptabio Therapeutics, Inc.
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.
Description
Patients with chronic kidney disease undergoing percutaneous coronary intervention deserve careful consideration of various clinical options to minimize the risk of contrast-induced acute kidney injury and to optimize clinical outcomes. Contrast-induced acute kidney injury (CI-AKI) is a leading cause of a hospital-acquired renal failure and has been reported to affect both the mortality and morbidity of patients receiving contrast media. Contrast-induced acute kidney injury is the third leading cause of hospital-acquired acute kidney injury and has been recognized as a serious complication of…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Willing and able to provide informed consent. 2. 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. 3. Diagnosed with coronary artery disease. 4. Planned to undergo coronary angiography within 4 weeks of being consented. 5. 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. 6. Women of childbearing potential or males wi…
Interventions
- DrugIsuzinaxib (APX-115)
Treatment allocation in 1:1 ratio to Isuzinaxib or Placebo
- DrugPlacebo
Treatment allocation in 1:1 ratio to Isuzinaxib or Placebo
Locations (14)
- Baylor Scott & White Research InstituteDallas, Texas
- Kangwon National University HospitalChuncheon
- Keimyung University Dongsan HospitalDaegu
- Chungnam National University HospitalDaejeon
- Inje University Ilsan Paik HospitalGoyang
- Chonnam National University HospitalGwangju