Actively Recruiting
Efficacy and Safety Study of Isuzinaxib in Subjects With DKD
Led by Aptabio Therapeutics, Inc. · Updated on 2025-07-18
186
Participants Needed
20
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, double-blinded, randomized, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PK, and efficacy of Isuzinaxib compared with placebo in subjects with DKD.
CONDITIONS
Official Title
Efficacy and Safety Study of Isuzinaxib in Subjects With DKD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 19 years or older at the time of consent
- Clinical diagnosis of type 2 diabetes and diabetic kidney disease (DKD)
- Body mass index between 18.5 and 35 kg/m²
- Stable urine albumin-creatinine ratio (UACR) values before screening
- UACR between 200 and 3000 mg/g
- Hemoglobin A1c 10% or less at screening
- Stable dosage of ACE inhibitor or angiotensin receptor blocker medication
- Stable anti-hyperglycemic treatment before screening
- Commitment to use effective birth control if sexually active and of childbearing potential
- Willingness to follow dietary management for diabetes
- Willingness to comply with all study procedures and be available for the study duration
- Ability to understand and voluntarily provide signed informed consent
You will not qualify if you...
- History of type 1 diabetes mellitus or gestational diabetes
- Renal impairment or albuminuria not caused by DKD
- History of renal transplant or plan for renal transplant during the study
- History of acute kidney injury or renal dialysis
- Uncontrolled blood pressure
- Use of immunosuppressant medications
- Known or suspected allergy to any components of the study drug
- Significant abnormal laboratory findings at screening
- History of drug or alcohol abuse within one year prior to screening
- History of cardiovascular events or planned cardiovascular procedures during the study
- Current or past New York Heart Association class III or IV heart failure
- Significant electrocardiogram abnormalities
- Known significant liver disease
- Active urinary tract infection not resolved before randomization
- History of cancer within five years before screening
- Use of any investigational product
- Major surgery within 28 days before randomization or planned major surgery within six months
- Positive hepatitis B surface antigen
- Pregnant or breastfeeding female
- Other medical conditions deemed unsuitable by the investigator
- Likely non-compliance or inability to cooperate due to language or mental status issues
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 20 locations
1
Korea University Ansan Hospital
Ansan-si, South Korea
Actively Recruiting
2
Inje university Busan Paik Hospital
Busan, South Korea
Not Yet Recruiting
3
Pusan National University Hospital
Busan, South Korea
Actively Recruiting
4
SoonChunHyang University Hospital Cheonan
Cheonan, South Korea
Actively Recruiting
5
Keimyung University Daegu Dongsan Hospital
Daegu, South Korea
Actively Recruiting
6
Inje university Ilsan Paik Hospital
Goyang-si, South Korea
Actively Recruiting
7
Hanyang University Guri Hospital
Guri-si, South Korea
Actively Recruiting
8
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, South Korea
Actively Recruiting
9
The Catholic University of Korea Incheon St. Mary's Hospital
Incheon, South Korea
Actively Recruiting
10
Jeonbuk National University Hospital
Jeonju, South Korea
Not Yet Recruiting
11
CHA Bundang Medical Center
Seongnam-si, South Korea
Actively Recruiting
12
Boramae Medical Center
Seoul, South Korea
Actively Recruiting
13
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
14
Kyung Hee University Hospital at Gangdon
Seoul, South Korea
Actively Recruiting
15
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
16
Severance Hospital
Seoul, South Korea
Actively Recruiting
17
The Catholic University of Korea Seoul ST.MARY'S Hospital
Seoul, South Korea
Actively Recruiting
18
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea
Actively Recruiting
19
Wonju Severance Christian Hospital
Wŏnju, South Korea
Not Yet Recruiting
20
Pusan National University Yangsan Hospital
Yangsan, South Korea
Actively Recruiting
Research Team
S
Sung Jun Lim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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