New drug aims to shield kidneys from heart surgery harm
NCT ID NCT07164833
First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study tests a drug called BX-001N to see if it can prevent acute kidney injury in people having heart surgery. About 40 adults will receive either a low dose, high dose, or a placebo. The goal is to see if the drug can keep kidneys working well after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BX-001N
- What this could lead to
- If it works, this could lead to a new way to prevent kidney damage after heart surgery, reducing the risk of long-term kidney problems.
- What could go wrong
- This is a small, early-phase trial with only 40 participants, so results may not apply to everyone. The drug may not prove effective or could have side effects.
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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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- 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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19 to 90 years
- 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. 19 to 90 years of age 2. Participants with aortic disease scheduled for cardiac surgery via total circulatory arrest (TCA) 3. Body weight ≥ 30 kg 4. Participants with vital signs within the following ranges * Temperature : 35.0\~37.5°C * Blood pressure : Systolic blood pressure(SBP) 100\~160 mmHg, Diastolic blood pressure(DBP) \< 100 mmHg * Pulse : 50\~100 bpm (regardless of drug use) 5. Willing to comply with the schedule and sign the informed consent 6. Participants with moderate renal impairement Exclusion Criteria: 1. Participants scheduled for emergent or salvage cardiac surgery 2. Use of kidney replacement therapy (KRT) or presence of acute kidney injury (AKI) 3. Participants at risk of bleeding 4. Participants who underwent cardiac surgery via mid-sternotomy or thoracotomy, including major congenital heart disease 5. Participants who received cardiopulmonary resuscitation within 30 days prior to cardiac surgery 6. Recipient of a solid organ or bone marrow transplantation 7. Participants with cardiogenic shock or hemodynamics instability, or planned use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device 8. Active systemic bacterial, viral, or fungal infection 9. History of HIV 10. Positive serology test for HAV, HBV, HCV or Syphilis 11. Participants with impaired liver function due to cirrhosis, or those with 2x UNR blood levels of ALP, AST, or ALT, or with total bilirubin levels outside the normal range 12. Uncontrolled hypertension 13. History of congenital immunodeficiency 14. Genetic disorder with severe and abnormal bilirubin metabolism 15. Participants deemed unsuitable for the study in the discretion of the investigator 16. History of malignancy 17. Planned use of any pharmacologic agent other than the IP assigned in this study for the prevention or treatment of acute kidney injury 18. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents 19. History of participation in other clinical trials within 30 days 20. Presence of a do-not-resuscitate order or life expectancy of \< 3 months 21. Female subjects of childbearing potential 22. Male subjects and their spouse/partner are not willing to use appropriate contraception, or if their spouse/partner is pregnant, breastfeeding or has a plan 23. Poorly controlled type 2 diabetes mellitus 24. New York Heart Association (NYHA) Class IV heart failure
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Keimyung University Dongsan Medical Center
NOT_YET_RECRUITINGDaegu, 42601, South Korea
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Korea University Anam Hospital
RECRUITINGSeoul, 02841, South Korea
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Pusan National University Yangsan Hospital
RECRUITINGYangsan, 50612, South Korea
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Samsung Medical Center
NOT_YET_RECRUITINGSeoul, 06351, South Korea
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Seoul Asan Medical center
RECRUITINGSeoul, 05505, South Korea
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Seoul National University Bundang Hospital
NOT_YET_RECRUITINGSeongnam, 13620, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
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Severance Hospital
RECRUITINGSeoul, 03722, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A simple protein test might flag kidney danger after heart surgery
- Can a new valve fix a leaky heart without open surgery?
- Ear zaps during heart attack may shield the heart from damage
- Warm liver transplants: could ditching the ice bath reduce organ damage?
- Liver biopsy during machine perfusion may reveal organ viability before transplant
- Gentle touch after Open-Heart surgery: can massage help you breathe easier?