Ischemia Reperfusion InjuryPhase 2NCT07164833
A Study to Evaluate the Efficacy and Safety of BX-001N in Preventing Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Major Adverse Kidney Events (MAKE)
A Phase 2 study testing BX-001N Experimental group 1 and BX-001N Experimental group 2 in people with Ischemia Reperfusion Injury and Cardiac Surgery Associated - Acute Kidney Injury, run by Bilix Co.,Ltd. at 8 sites in South Korea.
Trial summary
This is a Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a clinical trial of BX-001N to prevent patients from Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and subsequent Major Adverse Kidney Events (MAKE) in approximately 50 participants. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Ischemia Reperfusion Injury, Cardiac Surgery Associated - Acute Kidney Injury
- What is being tested?
- BX-001N Experimental group 1 and BX-001N Experimental group 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 26 Aug 2025to Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 to 90 years of age
- Participants with aortic disease scheduled for cardiac surgery via total circulatory arrest (TCA)
- Body weight ≥ 30 kg
- 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
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- Pulse : 50~100 bpm (regardless of drug use)
- Willing to comply with the schedule and sign the informed consent
- Participants with moderate renal impairement
Who cannot join
- Participants scheduled for emergent or salvage cardiac surgery
- Use of kidney replacement therapy (KRT) or presence of acute kidney injury (AKI)
- Participants at risk of bleeding
- Participants who underwent cardiac surgery via mid-sternotomy or thoracotomy, including major congenital heart disease
- Participants who received cardiopulmonary resuscitation within 30 days prior to cardiac surgery
- Recipient of a solid organ or bone marrow transplantation
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- Participants with cardiogenic shock or hemodynamics instability, or planned use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device
- Active systemic bacterial, viral, or fungal infection
- History of HIV
- Positive serology test for HAV, HBV, HCV or Syphilis
- 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
- Uncontrolled hypertension
- History of congenital immunodeficiency
- Genetic disorder with severe and abnormal bilirubin metabolism
- Participants deemed unsuitable for the study in the discretion of the investigator
- History of malignancy
- Planned use of any pharmacologic agent other than the IP assigned in this study for the prevention or treatment of acute kidney injury
- History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents
- History of participation in other clinical trials within 30 days
- Presence of a do-not-resuscitate order or life expectancy of < 3 months
- Female subjects of childbearing potential
- 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
- Poorly controlled type 2 diabetes mellitus
- New York Heart Association (NYHA) Class IV heart failure
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
South Korea8 sites, 8 recruiting
- Not yet recruiting
Keimyung University Dongsan Medical Center
Daegu, 42601
Keimyung University Dongsan Medical Center IRB, +82-53-258-6694, irbdsmc@naver.com
Yun Seok Kim, MD, PhD
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Seoul National University Bundang Hospital IRB, +82-31-787-8801, snubhirb@gmail.com
Jae Hang Lee, MD, PhD
- Recruiting
Korea University Anam Hospital
Seoul, 02841
KU Medicine HRPC, +82-2-920-6086, aarst@kumc.or.kr
Hee Jung Kim, MD, PhD
- Recruiting
Seoul National University Hospital
Seoul, 03080
Seoul National University Hospital IRB, +82-2-2072-0694, irb@snuh.org
Jae Woong Choi, MD, PhD
- Recruiting
Severance Hospital
Seoul, 03722
Severance Hospital Clinical Trial Center, +82-2-2228-0430, irb@yuhs.ac
Hyun Chel Joo, MD, PhD
- Recruiting
Seoul Asan Medical center
Seoul, 05505
AMC IRB, +82-2-3010-7166, irb@amc.seoul.kr
Joon Bum Kim, MD, PhD
- Not yet recruiting
Samsung Medical Center
Seoul, 06351
Samsung Medical Center IRB, +82-2-3410-2973, younjin.rhee@samsung.com
Su Ryeun Chung, MD
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, 50612
Pusan National University Yangsan Hospital IRB, +82-55-360-3854, pnuyhctc@pnuyh.co.kr
Chee Hoon Lee, MD
About this study
Official title: Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a Clinical Trial of BX-001N to Prevent From Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE)
This is a Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a clinical trial of BX-001N to prevent patients from Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and subsequent Major Adverse Kidney Events (MAKE) in approximately 50 participants.
Read the detailed description
This study will enroll approximately 50 participants, with 16 participants randomized to Experimental Group 1 and 4 participants to the Placebo Group 1, 15 participants to Experimental Group 2 and 15 participants to the Placebo Group 2.
Randomized participants will be hospitalized from one day prior to surgery (Baseline, Day -1) through Day 7.
Investigational product (IP) (i.e., BX-001N) will be administered intravenously at a weight-based dose as follows: The test drug will be administered three times in total. Participants in the Placebo Group will receive placebo at the same time points and in the same manner.
Follow-up visits will be conducted up to Day 90 at the study site for scheduled efficacy and safety assessments.
- Being tested
- BX-001N Experimental group 1, BX-001N Experimental group 2, Placebo group 1, Placebo group 2
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BX-001N Experimental group 1Drug
Each participant will receive BX-001N at a weight-based low dose via IV injection once daily for a total of three administrations.
BX-001N Experimental group 2Drug
Each participant will receive BX-001N at a weight-based high dose via IV injection once daily at the same time during hospitalization, for a total of three administrations.
Placebo group 1Drug
Each participant will receive Placebo at a weight-based dose via IV injection once daily at the same time during hospitalization, for a total of three administrations.
Placebo group 2Drug
Each participant will receive Placebo at a weight-based dose via IV injection once daily at the same time during hospitalization, for a total of three administrations.
| Study group | Role | What they receive |
|---|---|---|
| BX-001N Experimental group 1 | Experimental | Three low doses of BX-001N once a day on the scheduled date Receives: Drug: BX-001N Experimental group 1 |
| BX-001N Experimental group 2 | Experimental | Three high doses of BX-001N once a day on the scheduled date Receives: Drug: BX-001N Experimental group 2 |
| Placebo group 1 | Placebo comparator | Three low doses of placebo once a day on the scheduled date Receives: Drug: Placebo group 1 |
| Placebo group 2 | Placebo comparator | Three high doses of placebo once a day on the scheduled date Receives: Drug: Placebo group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in NGAL levels
Measured: Baseline(Day -1) to Day 7
Change from baseline in sCr levels
Measured: Baseline(Day -1) to Day 7
Change from baseline in eGFR
Measured: Baseline(Day -1) to Day 30
Secondary outcomes (6)
Change from baseline in CysC
Measured: Baseline(Day -1) to Day 7
Change from baseline in TIMP-2
Measured: Baseline(Day -1) to Day 7
Change from baseline in IGFBP7
Measured: Baseline(Day -1) to Day 7
Collection of Major Adverse Renal Events [MAKE]
Measured: Up to Day 90
Change from baseline in Incidence of AKI based on Kidney Disease: Improving Global Outcomes [KDIGO] criteria
[Staging of AKI] Stage 1 : 1.5-1.9 times baseline or ≥0.3mg/dL increase Stage 2 : 2.0-2.9 times baseline Stage 3 : 3.0 times baseline or increase in serum creatinine to ≥4.0mg/dL or Initiation of renal replacement therapy
Measured: Baseline(Day -1) to Day 7
Change from baseline in BUN
Measured: Baseline(Day -1) to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start26 Aug 2025
- Primary completionSep 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia Reperfusion 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bilix Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Lip Kim, Chief Executive Officer, Study chair, Bilix Co.,Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164833
- Sponsor's protocol ID
- BX-001N-002
- Status last verified
- Jun 2026
- First submitted
- 27 Aug 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a Clinical Trial of BX-001N to Prevent From Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE)
- ClinicalTrials.gov ID
- NCT07164833
- Acronym / sponsor ID
- BX-001N-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bilix Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 10 Sep 2025 (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 is a Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a clinical trial of BX-001N to prevent patients from Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and subsequent Major Adverse Kidney Events (MAKE) in approximately 50 participants.
Detailed description
This study will enroll approximately 50 participants, with 16 participants randomized to Experimental Group 1 and 4 participants to the Placebo Group 1, 15 participants to Experimental Group 2 and 15 participants to the Placebo Group 2.
Randomized participants will be hospitalized from one day prior to surgery (Baseline, Day -1) through Day 7.
Investigational product (IP) (i.e., BX-001N) will be administered intravenously at a weight-based dose as follows: The test drug will be administered three times in total. Participants in the Placebo Group will receive placebo at the same time points and in the same manner.
Follow-up visits will be conducted up to Day 90 at the study site for scheduled efficacy and safety assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BX-001N Experimental group 1 | Experimental | Drug: BX-001N Experimental group 1Three low doses of BX-001N once a day on the scheduled date |
| BX-001N Experimental group 2 | Experimental | Drug: BX-001N Experimental group 2Three high doses of BX-001N once a day on the scheduled date |
| Placebo group 1 | Placebo comparator | Drug: Placebo group 1Three low doses of placebo once a day on the scheduled date |
| Placebo group 2 | Placebo comparator | Drug: Placebo group 2Three high doses of placebo once a day on the scheduled date |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 19 to 90 years of age
- Participants with aortic disease scheduled for cardiac surgery via total circulatory arrest (TCA)
- Body weight ≥ 30 kg
- Participants with vital signs within the following ranges
- Willing to comply with the schedule and sign the informed consent
Key exclusion criteria (24 listed)
- Participants scheduled for emergent or salvage cardiac surgery
- Use of kidney replacement therapy (KRT) or presence of acute kidney injury (AKI)
- Participants at risk of bleeding
- Participants who underwent cardiac surgery via mid-sternotomy or thoracotomy, including major congenital heart disease
- Participants who received cardiopulmonary resuscitation within 30 days prior to cardiac surgery
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 |
|---|---|---|
| BX-001N Experimental group 1Each participant will receive BX-001N at a weight-based low dose via IV injection once daily for a total of three administrations. | Drug | BX-001N Experimental group 1 |
| BX-001N Experimental group 2Each participant will receive BX-001N at a weight-based high dose via IV injection once daily at the same time during hospitalization, for a total of three administrations. | Drug | BX-001N Experimental group 2 |
| Placebo group 1Each participant will receive Placebo at a weight-based dose via IV injection once daily at the same time during hospitalization, for a total of three administrations. | Drug | Placebo group 1 |
| Placebo group 2Each participant will receive Placebo at a weight-based dose via IV injection once daily at the same time during hospitalization, for a total of three administrations. | Drug | Placebo group 2 |
Primary outcome
Change from baseline in NGAL levels
Time frame: Baseline(Day -1) to Day 7
Change from baseline in sCr levels
Time frame: Baseline(Day -1) to Day 7
Change from baseline in eGFR
Time frame: Baseline(Day -1) to Day 30
6 secondary outcomes
Change from baseline in CysC
Time frame: Baseline(Day -1) to Day 7
Change from baseline in TIMP-2
Time frame: Baseline(Day -1) to Day 7
Change from baseline in IGFBP7
Time frame: Baseline(Day -1) to Day 7
Collection of Major Adverse Renal Events [MAKE]
Time frame: Up to Day 90
Change from baseline in Incidence of AKI based on Kidney Disease: Improving Global Outcomes [KDIGO] criteria
Time frame: Baseline(Day -1) to Day 7
Change from baseline in BUN
Time frame: Baseline(Day -1) to Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Myung Lip Kim, Chief Executive Officer study chair
Bilix Co.,Ltd.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BX-001N Experimental group 1 and BX-001N Experimental group 2 in people with Ischemia Reperfusion Injury and Cardiac Surgery Associated - Acute Kidney Injury, run by Bilix Co.,Ltd. at 8 sites in South Korea.
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 9 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Choonmo Kang (+82-70-7791-5721, choonmo.kang@bilix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in NGAL levels (time frame: Baseline(Day -1) to Day 7). The study lists 3 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 1 Jul 2026.