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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Bilix Co.,Ltd.
- Enrollment
- 50
- Locations
- 8
- Primary Endpoint
- Change from baseline in NGAL levels
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 19 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Exclusion Criteria
- •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 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
Arms & Interventions
BX-001N Experimental group 1
Three low doses of BX-001N once a day on the scheduled date
Intervention: BX-001N Experimental group 1 (Drug)
BX-001N Experimental group 2
Three high doses of BX-001N once a day on the scheduled date
Intervention: BX-001N Experimental group 2 (Drug)
Placebo group 1
Three low doses of placebo once a day on the scheduled date
Intervention: Placebo group 1 (Drug)
Placebo group 2
Three high doses of placebo once a day on the scheduled date
Intervention: Placebo group 2 (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change from baseline in IGFBP7(Baseline(Day -1) to Day 7)
- Collection of Major Adverse Renal Events [MAKE](Up to Day 90)
- Change from baseline in Incidence of AKI based on Kidney Disease: Improving Global Outcomes [KDIGO] criteria(Baseline(Day -1) to Day 7)
- Change from baseline in CysC(Baseline(Day -1) to Day 7)
- Change from baseline in TIMP-2(Baseline(Day -1) to Day 7)
- Change from baseline in BUN(Baseline(Day -1) to Day 30)