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Tests treatment safety and results for Ischemia Reperfusion Injury
Official title 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)
ClinicalTrials.gov ID: NCT07164833
What this study is testing
What is BX-001N Experimental group 1?
BX-001N Experimental group 1 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for ischemia reperfusion injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 90
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- Pulse : 50\~100 bpm (regardless of drug use)
- Willing to comply with the schedule and sign the informed consent
- Participants with moderate renal impairement
- 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
- 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 people of childbearing potential
- Male people 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
The study team makes the final eligibility decision.
Where it's taking place
- Daegu, South Korea
- Seongnam, South Korea
- Seoul, South Korea
- Yangsan, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Daegu, South Korea; Seongnam, South Korea; Seoul, South Korea; Yangsan, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.