New drug aims to shield kidneys from dye damage during heart surgery
NCT ID NCT05758896
First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This study tests whether the drug APX-115 can prevent kidney injury caused by contrast dye used in heart procedures. About 230 adults with kidney disease will receive either the drug or a placebo before and after their procedure. The goal is to see if the drug reduces kidney damage and is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Isuzinaxib (APX-115)
- What this could lead to
- If it works, this could point toward a way to prevent kidney injury from contrast dye in people with reduced kidney function.
- What could go wrong
- This is an early phase 2 trial, so results may not confirm benefit. The drug could cause side effects or fail to outperform placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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218 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Jul 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 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. CKD stage 4 and 5 confirmed by eGFR \< 30 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 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 and 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 \<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. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baylor Scott & White Research Institute
Dallas, Texas, 75204, United States
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Chonnam National University Hospital
Gwangju, South Korea
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Chungnam National University Hospital
Daejeon, South Korea
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Inje University Ilsan Paik Hospital
Goyang, South Korea
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Kangbuk Samsung Hospital
Seoul, South Korea
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Kangwon National University Hospital
Chuncheon, South Korea
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Keimyung University Dongsan Hospital
Daegu, South Korea
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Korea University Anam Hospital
Seoul, South Korea
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Samsung Medical Center
Seoul, South Korea
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Seoul National University Bundang Hospital
Seongnam-si, South Korea
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Seoul National University Hospital
Seoul, South Korea
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The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
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The Catholic University of Korea St. Vincent's Hospital
Suwon, South Korea
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Ulsan University Hospital
Ulsan, South Korea
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Other studies related to the condition(s) this trial covers.
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- Zapping the ear: a new way to stop Post-Surgery heart rhythm problems?