Contrast Induced Acute Kidney InjuryPhase 2NCT05758896
Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI
A Phase 2 study testing Isuzinaxib (APX-115) in people with Contrast Induced Acute Kidney Injury, run by Aptabio Therapeutics, Inc. at 14 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Induced Acute Kidney Injury
- What is being tested?
- Isuzinaxib (APX-115)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 27 Dec 2023to 22 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
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- 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.
- 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.
- Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation with protocol requirements
- 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
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
South Korea13 sites
Kangwon National University Hospital
Chuncheon
Keimyung University Dongsan Hospital
Daegu
Chungnam National University Hospital
Daejeon
Inje University Ilsan Paik Hospital
Goyang
Chonnam National University Hospital
Gwangju
Seoul National University Bundang Hospital
Seongnam-si
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
The Catholic University of Korea St. Vincent's Hospital
Suwon
Ulsan University Hospital
Ulsan
United States1 site
Baylor Scott & White Research Institute
Dallas, Texas, 75204
About this study
Official title: 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 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.
Read the detailed 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 percutaneous coronary intervention (PCI), which may be associated with increased morbidity and mortality.
APX-115 is a potent small molecule inhibitor of NADPH-oxidase (NOX) isozymes developed by AptaBio Therapeutics, Inc. In-vivo study results suggest that multiple NOX isoforms may contribute to renal injury in CI-AKI model, and pan-NOX inhibition may be a new therapeutic approach for prevention of CI-AKI.
- Conditions
- Contrast Induced Acute Kidney Injury
- Being tested
- Isuzinaxib (APX-115), Placebo
- Keywords
- Isuzinaxib, APX-115, Contrast media, ROS, Acute Kidney Injury, Percutaneous Coronary Intervention
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isuzinaxib (APX-115)Drug
Also called Isuzinaxib Hydrochloride
Treatment allocation in 1:1 ratio to Isuzinaxib or Placebo
PlaceboDrug
Treatment allocation in 1:1 ratio to Isuzinaxib or Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Isuzinaxib (APX-115) |
| Placebo | Placebo comparator | 4 x Placebo capsules administered QD, orally, for 5 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoints: adverse event
Number of adverse events
Measured: Day -2 to day 84
Safety endpoints: vital sign
Number of subjects with abnormal Vital Signs
Measured: Day 0 to day 84
Safety endpoints: physical exam
Abnormal physical examination
Measured: Day 0 to day 84
Safety endpoints: ECG
Abnormal Electrocardiogram (ECG)
Measured: Day 0 to day 84
Safety endpoints: labs
Number of abnormal results of Hematology, Biochemistry and Urinalysis
Measured: Day 0 to day 84
Secondary outcomes (21)
Incidence rate of Acute kidney injury
definition of CI-AKI: Serum Creatinine absolute variation ≥ 0.5mg/dL or Serum creatinine relative variation increasing 25% from baseline up to 72 hours after CAG with the exposure of contrast medium and PCI
Measured: from baseline up to 72 hours after PCI procedure
Long term kidney function: Serum creatinine
Serum creatinine level
Measured: week 4 and week 12
Long term kidney function: eGFR
eGFR level
Measured: week 4 and week 12
Kidney function parameters: creatinine, BUN
Serum creatinine and BUN level
Measured: over 12-week period
Kidney function parameters: eGFR
eGFR using CKD-EPI
Measured: over 12-week period
pharmacokinetics parameters: the area under the plasma concentration-time curve (AUC0-last, AUCtau)
to be assessed from plasma and urine samples (subset of subjects only)
Measured: Day -2~2
pharmacokinetics parameters: peak concentration (Cmax, Tmax)
to be assessed from plasma and urine samples (subset of subjects only)
Measured: Day -2~2
pharmacokinetics parameters: steady state peak plasma concentration (Css,max)
to be assessed from plasma and urine samples (subset of subjects only)
Measured: Day -2~2
pharmacokinetics parameters: steady state trough plasma concentration (Css,min)
to be assessed from plasma and urine samples (subset of subjects only)
Measured: Day -2~2
pharmacokinetics parameters: steady state after 5 consecutive days of drug administration
to be assessed from plasma and urine samples (subset of subjects only)
Measured: Day -2~2
pharmacokinetics parameters: apparent total clearance (CL/F)
to be assessed from plasma and urine samples (subset of subjects only)
Measured: Day -2~2
pharmacokinetics parameters: renal clearance (CLR)
to be assessed from plasma and urine samples (subset of subjects only)
Measured: Day -2~2
pharmacokinetics parameters: apparent nonrenal clearance (CLNR/F)
to be assessed from plasma and urine samples (subset of subjects only)
Measured: Day -2~2
pharmacokinetics parameters: apparent volume of distribution (V/F)
to be assessed from plasma and urine samples (subset of subjects only)
Measured: Day -2~2
pharmacokinetics parameters: terminal half-life (t1/2)
to be assessed from plasma and urine samples (subset of subjects only)
Measured: Day -2~2
pharmacokinetics parameters: fraction/cumulated fraction of excreted in urine
to be assessed from plasma and urine samples (subset of subjects only)
Measured: Day -2~2
Adverse event in patients with eGFR < 45 mL/min/1.73m2
Number of adverse events
Measured: Day -2 to day 84
Vital signs in patients with eGFR < 45 mL/min/1.73m2
number of subjects with abnormal vital signs
Measured: Day 0 to day 84
Number of subjects with eGFR < 45 mL/min/1.73m2 with clinically significant findings on physical examination
The number of subjects within the specified subgroup who exhibit clinically significant abnormal findings based on investigator's physical examination will be assessed over time.
Measured: Day 0 to day 84
Number of subjects with eGFR < 45 mL/min/1.73m2 with normal or abnormal electrocardiogram (ECG) results
The number of subjects within the specified subgroup who exhibit normal or abnormal ECG findings will be assessed over time.
Measured: Day 0 to day 84
Labs in patients with eGFR < 45 mL/min/1.73m2
Number of abnormal results of hematology, biochemistry and urinalysis
Measured: Day 0 to day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start27 Dec 2023
- Primary completion22 Jul 2026
- Study completion22 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Induced Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptabio Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758896
- Sponsor's protocol ID
- A01-115-04
- Status last verified
- Aug 2026
- First submitted
- 27 May 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05758896
- Acronym / sponsor ID
- A01-115-04
- Conditions
- Contrast Induced Acute Kidney Injury
- Keywords
- Isuzinaxib, APX-115, Contrast media, ROS, Acute Kidney Injury, Percutaneous Coronary Intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Aptabio Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 22 Jul 2026 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 percutaneous coronary intervention (PCI), which may be associated with increased morbidity and mortality.
APX-115 is a potent small molecule inhibitor of NADPH-oxidase (NOX) isozymes developed by AptaBio Therapeutics, Inc. In-vivo study results suggest that multiple NOX isoforms may contribute to renal injury in CI-AKI model, and pan-NOX inhibition may be a new therapeutic approach for prevention of CI-AKI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isuzinaxib (APX-115) | Experimental | Drug: Isuzinaxib (APX-115)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 |
| Placebo | Placebo comparator | Drug: Placebo4 x Placebo capsules administered QD, orally, for 5 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 30 mL/min/1.73m2 ≤ eGFR (Glomerular filtration rate) < 90 mL/min/1.73 m2 confirmed by local or central laboratory.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isuzinaxib (APX-115)Also: Isuzinaxib HydrochlorideTreatment allocation in 1:1 ratio to Isuzinaxib or Placebo | Drug | Isuzinaxib (APX-115) |
| PlaceboTreatment allocation in 1:1 ratio to Isuzinaxib or Placebo | Drug | Placebo |
Primary outcome
Safety endpoints: adverse event
Time frame: Day -2 to day 84
Number of adverse events
Safety endpoints: vital sign
Time frame: Day 0 to day 84
Number of subjects with abnormal Vital Signs
Safety endpoints: physical exam
Time frame: Day 0 to day 84
Abnormal physical examination
Safety endpoints: ECG
Time frame: Day 0 to day 84
Abnormal Electrocardiogram (ECG)
Safety endpoints: labs
Time frame: Day 0 to day 84
Number of abnormal results of Hematology, Biochemistry and Urinalysis
21 secondary outcomes
Incidence rate of Acute kidney injury
Time frame: from baseline up to 72 hours after PCI procedure
Long term kidney function: Serum creatinine
Time frame: week 4 and week 12
Long term kidney function: eGFR
Time frame: week 4 and week 12
Kidney function parameters: creatinine, BUN
Time frame: over 12-week period
Kidney function parameters: eGFR
Time frame: over 12-week period
pharmacokinetics parameters: the area under the plasma concentration-time curve (AUC0-last, AUCtau)
Time frame: Day -2~2
pharmacokinetics parameters: peak concentration (Cmax, Tmax)
Time frame: Day -2~2
pharmacokinetics parameters: steady state peak plasma concentration (Css,max)
Time frame: Day -2~2
pharmacokinetics parameters: steady state trough plasma concentration (Css,min)
Time frame: Day -2~2
pharmacokinetics parameters: steady state after 5 consecutive days of drug administration
Time frame: Day -2~2
pharmacokinetics parameters: apparent total clearance (CL/F)
Time frame: Day -2~2
pharmacokinetics parameters: renal clearance (CLR)
Time frame: Day -2~2
pharmacokinetics parameters: apparent nonrenal clearance (CLNR/F)
Time frame: Day -2~2
pharmacokinetics parameters: apparent volume of distribution (V/F)
Time frame: Day -2~2
pharmacokinetics parameters: terminal half-life (t1/2)
Time frame: Day -2~2
pharmacokinetics parameters: fraction/cumulated fraction of excreted in urine
Time frame: Day -2~2
Adverse event in patients with eGFR < 45 mL/min/1.73m2
Time frame: Day -2 to day 84
Vital signs in patients with eGFR < 45 mL/min/1.73m2
Time frame: Day 0 to day 84
Number of subjects with eGFR < 45 mL/min/1.73m2 with clinically significant findings on physical examination
Time frame: Day 0 to day 84
Number of subjects with eGFR < 45 mL/min/1.73m2 with normal or abnormal electrocardiogram (ECG) results
Time frame: Day 0 to day 84
Labs in patients with eGFR < 45 mL/min/1.73m2
Time frame: Day 0 to day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isuzinaxib (APX-115) in people with Contrast Induced Acute Kidney Injury, run by Aptabio Therapeutics, Inc. at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in South Korea, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoints: adverse event (time frame: Day -2 to day 84). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.