Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI

NCT05758896 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: A01-115-04
• Study Type: interventional
• Target: 230
• Locations: 2 countries
• Sites: 14

Brief 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.

Conditions

Contrast Induced Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Safety endpoints: adverse event

  Number of adverse events

  Day -2 to day 84

• Safety endpoints: vital sign

  Number of subjects with abnormal Vital Signs

  Day 0 to day 84

• Safety endpoints: physical exam

  Abnormal physical examination

  Day 0 to day 84

• Safety endpoints: ECG

  Abnormal Electrocardiogram (ECG)

  Day 0 to day 84

• Safety endpoints: labs

  Number of abnormal results of Hematology, Biochemistry and Urinalysis

  Day 0 to day 84

Secondary Outcomes (21)

• Incidence rate of Acute kidney injury

  from baseline up to 72 hours after PCI procedure

• Long term kidney function: Serum creatinine

  week 4 and week 12

• Long term kidney function: eGFR

  week 4 and week 12

• Kidney function parameters: creatinine, BUN

  over 12-week period

• Kidney function parameters: eGFR

  over 12-week period

Other Outcomes (2)

• Biomarkers assessment

  72 hours

• Composite PCI outcome

  over 12-week period

Study Arms (2)

Isuzinaxib (APX-115)

EXPERIMENTAL

4 x Isuzinaxib 88 mg calculated as free base (4 x 100mg APX-115(Isuzinaxib hydrocloride) capsules as salt form) administered QD, orally, for 5 consecutive days

Drug: Isuzinaxib (APX-115)

Placebo

PLACEBO COMPARATOR

4 x Placebo capsules administered QD, orally, for 5 consecutive days

Drug: Placebo

Interventions

Isuzinaxib (APX-115) DRUG

Treatment allocation in 1:1 ratio to Isuzinaxib or Placebo

Also known as: Isuzinaxib Hydrochloride

Isuzinaxib (APX-115)

Placebo DRUG

Treatment allocation in 1:1 ratio to Isuzinaxib or Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• History of acute kidney injury or renal dialysis within 1 month prior to Screening and/or plan to undergo a renal dialysis during enrolment.
• Clinically apparent liver disease as determined by the Investigator or moderate or severe hepatic impairment as determined by Child-Pugh score (Class B or C) at Screening.
• Impaired liver function, defined as alanine aminotransferase (ALT) \> 2.5 times UNL and Total bilirubin \>1.5 × ULN, unless the subject has known Gilbert's syndrome.
• Any sign or symptom of acute or chronic infection at Screening.
• Receipt of any investigational drug within 4 weeks prior to Screening.
• Confirmed or suspected abuse of alcohol or controlled substances within 1 year prior to Screening.
• Clinically significant hematology abnormalities; hemoglobin \<9 g/dL for females or \<10 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.

Sponsors & Collaborators

• Aptabio Therapeutics, Inc.: lead

Study Sites (14)

Baylor Scott & White Research Institute

Dallas, Texas, 75204, United States

Location

Kangwon National University Hospital

Chuncheon, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

Location

The Catholic University of Korea St. Vincent's Hospital

Suwon, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

isuzinaxib

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: March 8, 2023
• Study Start: December 27, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

US (1); KR (13)