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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)

ConditionsIschemia Reperfusion InjuryCardiac Surgery Associated - Acute Kidney Injury
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-90
SponsorBilix Co.,Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • BX-001N Experimental group 1

    Drug

    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 2

    Drug

    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 1

    Drug

    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 2

    Drug

    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.

Treatment groups

50 Participants
are divided into 4 treatment groups
Group A: BX-001N Experimental group 1Experimental treatment 1 intervention
Group B: BX-001N Experimental group 2Experimental treatment 1 intervention
Group C: Placebo group 1Placebo comparator 1 intervention
Group D: Placebo group 2Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in NGAL levels

Time frame
Baseline(Day -1) to Day 7
2

Change from baseline in sCr levels

Time frame
Baseline(Day -1) to Day 7
3

Change from baseline in eGFR

Time frame
Baseline(Day -1) to Day 30

Secondary outcomes

1

Change from baseline in CysC

Time frame
Baseline(Day -1) to Day 7
2

Change from baseline in TIMP-2

Time frame
Baseline(Day -1) to Day 7
3

Change from baseline in IGFBP7

Time frame
Baseline(Day -1) to Day 7
4

Collection of Major Adverse Renal Events [MAKE]

Time frame
Up to Day 90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bilix Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov
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