Isuzinaxib for adults with diabetic kidney disease

A Phase 2b Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Study to Evaluate the Efficacy and Safety of Isuzinaxib in Subjects With Diabetic Kidney Disease

This trial tests whether isuzinaxib (APX-115) is safe and can reduce protein in the urine and protect kidneys in adults with type 2 diabetes and diabetic kidney disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 186 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Aptabio Therapeutics, Inc. (Indiv)
• Locations: 20 sites (Ansan-si and 19 other locations)
• Trial ID: NCT06962098 on ClinicalTrials.gov

What this trial studies

This multicenter, double-blind, randomized, placebo-controlled, dose-ranging Phase 2 trial compares oral isuzinaxib with placebo in adults who have type 2 diabetes and diabetic kidney disease. Eligible participants have UACR 200–3000 mg/g, BMI 18.5–35 kg/m2, HbA1c ≤10%, and must be on stable ACE inhibitor/ARB and glucose-lowering therapy prior to screening. The study measures safety, tolerability, pharmacokinetics, and effects on proteinuria and other kidney function markers over the treatment period. Recruitment and study visits are conducted at several academic hospitals in South Korea.

Who should consider this trial

Good fit: Adults (≥19 years) with type 2 diabetes and diabetic kidney disease, UACR 200–3000 mg/g, BMI 18.5–35 kg/m2, HbA1c ≤10%, and on stable RAAS blockade and antihyperglycemic therapy are the intended participants.

Not a fit: People with non-diabetic kidney disease, UACR outside the 200–3000 mg/g range, unstable glucose control, recent changes to ACEi/ARB or antihyperglycemic medications, or who cannot attend the Korea study sites are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If effective, isuzinaxib could lower albuminuria and slow the progression of kidney damage in people with DKD, potentially delaying the need for dialysis.

How similar studies have performed: NOX inhibition is an emerging approach with promising preclinical data and limited early clinical experience, so clinical benefit in DKD has not yet been firmly established.

Eligibility criteria

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.

Where this trial is running

Ansan-si and 19 other locations

• 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)

Study contacts

• Study coordinator: Sung Jun Lim

Conditions Diabetic Kidney Disease; Isuzinaxib; APX-115; NOX; Diabetic Nephropathy; DN; DKD