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Recruiting Phase 2

Efficacy and Safety Study of Isuzinaxib in Subjects With DKD

NCT06962098 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 2
Started
2025-05-26
Last updated
2025-07-18

Condition(s) studied

Diabetic Kidney Disease (DKD)

Investigational drug(s) / intervention(s)

IsuzinaxibPlacebo

Isuzinaxib: Oral dosing regimen once daily

Placebo: Oral dosing regimen once daily

Study summary

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Male/female subject aged ≥19 years inclusive at the time of informed consent. 2. Clinical diagnosis of type 2 diabetes and DKD. 3. 18.5 kg/m² \< body mass index \< 35 kg/m². 4. Stable UACR values prior to screening visit. 5. UACR between 200 and 3000 mg/g. 6. Hemoglobin A1c ≤10% at Screening Visit. 7. Subject who has been taking unchanged dosage of angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB) medication. 8. Subject who has been on stable anti-hyperglycemic prior to screening. 9. Females of childbearing potential/sexually active males with a partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control. 10. Willing to be under dietary management for diabetes. 11. Willing to comply with all study procedures and availability for the duration of the study. 12. Capable of understanding the content of and able voluntarily to provide a signed and dated written informed consent form (ICF) prior to any study procedures. Exclusion Criteria: 1. History of type 1 diabetes mellitus or gestational diabetes. 2. Subject's renal impairment and/or albuminuria is considered to be of origin other than DKD. 3. History of renal transplant and/or plan to undergo a renal transplant during the study. 4. History of acute kidney injury or renal dialysis. 5. Subject with uncontrolled blood pressure. 6. Subject taking immunosuppressant. 7. Subject with known or suspected hypersensitivity to any components of the APX-115 formulation. 8. Clinically significant abnormal laboratory findings at screening. 9. History of drug or alcohol abuse within 1 year prior to screening. 10. History of any cardiovascular event or cardiovascular procedure planned during the clinical study. 11. Current or history of New York Heart Association class III or IV heart failure. 12. Clinically significant electrocardiogram (ECG) abnormalities. 13. Known significant liver disease. 14. Subject with active urinary tract infection or has not fully recovered before randomization. 15. History of malignancy within 5 years prior to screening. 16. Administration of any investigational product. 17. Major surgery within 28 days or not fully recovered surgery prior to randomization or major surgery planned during the next 6 months. 18. Positive hepatitis B surface antigen. 19. Female subject who is pregnant or breastfeeding. 20. Other medical history which in the opinion of the Investigator would make the subject unsuitable for participation in the study. 21. Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study or unable to cooperate because of a language problem or poor mental status.

Primary outcome measure(s)

  • Efficacy endpoint: Urine Albumin-Creatinine Ratio — Over 24 Weeks
    Change in Urine Albumin-Creatinine Ratio from baseline through Week 24 in the Isuzinaxib treatment groups versus the placebo group

Trial sites (20)

FacilityCityRegionStatus
Korea University Ansan Hospital Ansan-si South Korea Recruiting
Inje university Busan Paik Hospital Busan South Korea Not Yet Recruiting
Pusan National University Hospital Busan South Korea Recruiting
SoonChunHyang University Hospital Cheonan Cheonan South Korea Recruiting
Keimyung University Daegu Dongsan Hospital Daegu South Korea Recruiting
Inje university Ilsan Paik Hospital Goyang-si South Korea Recruiting
Hanyang University Guri Hospital Guri-si South Korea Recruiting
Chung-Ang University Gwangmyeong Hospital Gwangmyeong South Korea Recruiting
The Catholic University of Korea Incheon St. Mary's Hospital Incheon South Korea Recruiting
Jeonbuk National University Hospital Jeonju South Korea Not Yet Recruiting
CHA Bundang Medical Center Seongnam-si South Korea Recruiting
Boramae Medical Center Seoul South Korea Recruiting
Korea University Guro Hospital Seoul South Korea Recruiting
Kyung Hee University Hospital at Gangdon Seoul South Korea Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Severance Hospital Seoul South Korea Recruiting
The Catholic University of Korea Seoul ST.MARY'S Hospital Seoul South Korea Recruiting
The Catholic University of Korea Uijeongbu St. Mary's Hospital Uijeongbu-si South Korea Recruiting
Wonju Severance Christian Hospital Wŏnju South Korea Not Yet Recruiting
Pusan National University Yangsan Hospital Yangsan South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06962098 on ClinicalTrials.gov ↗ ← All trials in South Korea