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New drug aims to shield kidneys from heart surgery harm

NCT ID NCT07164833

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

19 to 90 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Keimyung University Dongsan Medical Center

    NOT_YET_RECRUITING

    Daegu, 42601, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, 02841, South Korea

  • Pusan National University Yangsan Hospital

    RECRUITING

    Yangsan, 50612, South Korea

  • Samsung Medical Center

    NOT_YET_RECRUITING

    Seoul, 06351, South Korea

  • Seoul Asan Medical center

    RECRUITING

    Seoul, 05505, South Korea

  • Seoul National University Bundang Hospital

    NOT_YET_RECRUITING

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

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