Treatment for kidney injury caused by contrast media during heart procedures

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

This study is testing a new drug called APX-115 to see if it can help prevent kidney damage in patients with chronic kidney disease who are having heart procedures that use contrast media.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aptabio Therapeutics, Inc. (Indiv)
• Locations: 14 sites (Dallas, Texas and 13 other locations)
• Trial ID: NCT05758896 on ClinicalTrials.gov

What this trial studies

This phase 2 study evaluates the safety and efficacy of APX-115, a small molecule inhibitor, in preventing contrast-induced acute kidney injury (CI-AKI) in patients undergoing percutaneous coronary intervention (PCI). Approximately 280 patients will be randomized to receive either 400 mg of APX-115 or a placebo following multiple oral doses. The study aims to address the significant risk of CI-AKI, which is a common complication in patients with chronic kidney disease undergoing PCI. By targeting NADPH-oxidase isozymes, the study explores a novel therapeutic approach to mitigate renal injury associated with contrast media.

Who should consider this trial

Good fit: Ideal candidates include adults with chronic kidney disease who are scheduled for coronary angiography and are at risk for contrast-induced acute kidney injury.

Not a fit: Patients who are not at risk for contrast-induced acute kidney injury or those who are pregnant will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of kidney injury in patients undergoing heart procedures, improving overall patient outcomes.

How similar studies have performed: Other studies have explored similar approaches to prevent CI-AKI, but the specific use of APX-115 is novel and has not been extensively tested.

Eligibility criteria

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 willing and able to use at least one protocol-specified method of contraception for the duration of their enrolment.
7. 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:

1. Females who are pregnant or who are planning to become pregnant before the end of planned enrolment or who are breastfeeding.
2. Subjects who are not expected to go through PCI at the discretion of investigator or cardiologist
3. Subjects who have a history of hypersensitivity to contrast media or who cannot be administered contrast media according to investigator's discretion
4. Acute myocardial infarction within 1 month prior to Screening
5. ESRD confirmed by eGFR \< 15 mL/min/1.73 m2 at Screening.
6. 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.
7. 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).
8. Known or suspected hypersensitivity to any component of the APX-115 formulation.
9. History of acute kidney injury or renal dialysis within 1 month prior to Screening and/or plan to undergo a renal dialysis during enrolment.
10. Clinically apparent liver disease as determined by the Investigator (e.g., jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis) or moderate or severe hepatic impairment as determined by Child-Pugh score (Class B or C) at Screening.
11. Impaired liver function, defined as alanine aminotransferase (ALT) ≥ 2.5 times UNL or Total bilirubin \>1.5 × ULN, unless the subject has known Gilbert's syndrome.
12. Any sign or symptom of acute or chronic infection at Screening.
13. Receipt of any investigational drug within 4 weeks prior to Screening.
14. Confirmed or suspected abuse of alcohol or controlled substances within 1 year prior to Screening.
15. Clinically significant hematology abnormalities; hemoglobin \<9 g/dL for females or \<11 g/dL for males, absolute neutrophil count \<1500/mm3, platelet count \<100 × 109/L) at Screening. If any parameter is below the specified threshold, one hematology retest analyzed at the central or local laboratory within a week prior to randomization is permitted with the result of the last sample being conclusive.
16. Any other clinically significant medical condition or laboratory abnormality as determined by the Investigator that might jeopardize the safety of the subject, impair subject compliance, or impede safety/efficacy observations during enrolment.
17. Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation with protocol requirements
18. Use of CYP1A2, CYP2B6 and CYP3A4 substrates or UGT inhibitors and inducers or OAT3 substrates prior to enrollment or concurrently. It will be only accepted to be eligible to screening if the subjects' concomitant medications will be reviewed and approved by the medical monitor and/or sponsor prior to the initial study dose

Where this trial is running

Dallas, Texas and 13 other locations

• Baylor Scott & White Research Institute — Dallas, Texas, United States (Recruiting)
• Kangwon National University Hospital — Chuncheon, South Korea (Recruiting)
• Keimyung University Dongsan Hospital — Daegu, South Korea (Recruiting)
• Chungnam National University Hospital — Daejeon, South Korea (Recruiting)
• Inje University Ilsan Paik Hospital — Goyang, South Korea (Recruiting)
• Chonnam National University Hospital — Gwangju, South Korea (Recruiting)
• Seoul National University Bundang Hospital — Seongnam-si, South Korea (Recruiting)
• Kangbuk Samsung Hospital — Seoul, South Korea (Recruiting)
• Korea University Anam Hospital — Seoul, South Korea (Recruiting)
• Samsung Medical Center — Seoul, South Korea (Recruiting)
• Seoul National University Hospital — Seoul, South Korea (Recruiting)
• The Catholic University of Korea Seoul St. Mary's Hospital — Seoul, South Korea (Recruiting)
• The Catholic University of Korea St. Vincent's Hospital — Suwon, South Korea (Recruiting)
• Ulsan University Hospital — Ulsan, South Korea (Recruiting)

Study contacts

• Study coordinator: Aptabio Therapeutics Inc.

Conditions Contrast Induced Acute Kidney Injury; Isuzinaxib; APX-115; Contrast media; ROS; Acute Kidney Injury; Percutaneous Coronary Intervention