A Study to Evaluate the Efficacy and Safety of BX-001N in Preventing Cardiac Surgery-Associated A… (NCT07164833) | Clinical Trial Compass
RecruitingPhase 2
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)
South Korea50 participantsStarted 2025-08-26
Plain-language 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.
Who can participate
Age range
19 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
. Willing to comply with the schedule and sign the informed consent
. Participants with moderate renal impairement
Exclusion criteria
. Participants scheduled for emergent or salvage cardiac surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing BX-001N specifically to prevent acute kidney injury after cardiac surgery — before we consider this, can you tell me how likely I am to develop that kind of kidney injury based on my own kidney function and the surgery I'm having?
2Since this is a Phase 2 trial, what do we currently know about the safety of BX-001N in humans, and what risks might still be unknown at this stage?
3The trial is measuring NGAL, creatinine, and eGFR as markers of kidney function — does that mean the goal is mainly to see if the drug changes lab values, or is there evidence it would actually prevent longer-term kidney damage or the need for dialysis?
4Are there any standard protective measures — like specific IV fluids, medication adjustments, or surgical techniques — that are already used to reduce kidney injury during cardiac surgery, and how would participating in this trial compare to just using those?
5Given that this trial is still actively recruiting, what would my timeline look like — would enrolling delay my surgery, and how would my kidney function be monitored during and after the study compared to standard care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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