drugset / Trial / NCT05758896
Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2023-12-27
- Primary completion
- 2026-07-30
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isuzinaxib | Small molecule | 400 mg | Oral |