Isuzinaxib for adults with diabetic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Korea University Ansan Hospital
  Ansan-si, South Korea 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

Study contacts

• Study coordinator: Sung Jun Lim
• Email: cd@aptabio.com
• Phone: +82-31-365-3693

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Goal-Directed Heart, Kidney, and Metabolic Care to Help Adults with Diabetic Kidney Disease

  This trial tests a structured, early CKM care plan alongside usual care to see if it is feasible and safe for adults with type 2 diabetes and diabetic kidney disease who are at high cardiovascular risk.

  Recruiting Sunnybrook Health Sciences Centre · Toronto, Ontario · NCT07434791

• ANGPTL3 inhibition for adults with diabetic kidney disease

  This study tests whether two drugs that block ANGPTL3, ALN-ANG3 and evinacumab, are safe and help adults with type 2 diabetes who have diabetic kidney disease.

  Recruiting at 57 sites Phase 2 Regeneron Pharmaceuticals · Huntsville, Alabama and 58 other locations · NCT07271186

• Amimestrocel (umbilical cord mesenchymal stromal cells) for diabetic kidney disease

  This trial will test whether umbilical cord-derived mesenchymal stromal cells (Amimestrocel) can improve kidney function or reduce protein in adults with progressive diabetic kidney disease.

  Recruiting at 5 sites Phase 2 Chinese PLA General Hospital · Beijing, Beijing Municipality and 5 other locations · NCT06969807

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.