Efficacy and Safety Study of Isuzinaxib in Subjects With DKD

Phase 2

Recruiting

• Conditions: Diabetic Kidney Disease (DKD)
• Interventions: Drug: Placebo; Drug: Isuzinaxib

• Registration Number: NCT06962098
• Lead Sponsor: Aptabio Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-16
• Study First Submitted QC: 2025-04-29
• Study First Posted: 2025-05-08
• Study Start: 2025-05-26
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-18
• Primary Completion: 2027-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 186

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subject will receive the Placebo.
Isuzinaxib 400 mg	Isuzinaxib	Subject will receive the 400 mg of Isuzinaxib.
Isuzinaxib 200 mg	Isuzinaxib	Subject will receive the 200 mg of Isuzinaxib.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Efficacy endpoint: eGFR	Over 24 Weeks	Change from baseline in the eGFR
Efficacy endpoint: Urine Albumin-Creatinine Ratio	Over 20 Weeks	Change in Urine Albumin-Creatinine Ratio from baseline through Week 20 in the Isuzinaxib treatment groups versus the placebo group
Efficacy endpoint: Urine Albumin-Creatinine Ratio decrease	Over 24 Weeks	Subjects with a percentage decrease in Urine Albumin-Creatinine Ratio
Efficacy endpoint: Incidence of Composite Renal Outcome	Over 24 Weeks	Number of subjects with end-stage kidney disease, kidney-related death, or renal replacement therapy
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Over 24 Weeks	Incidence of treatment-emergent adverse events
PK Endpoint: Pharmacokinetics	Over 24 Weeks	Assessment of plasma concentrations of Isuzinaxib

Trial Locations

Locations (20)

Korea University Ansan Hospital; 🇰🇷 Ansan-si, Korea, Republic of

Inje university Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

SoonChunHyang University Hospital Cheonan; 🇰🇷 Cheonan, Korea, Republic of

Keimyung University Daegu Dongsan Hospital; 🇰🇷 Daegu, Korea, Republic of

Inje university Ilsan Paik Hospital; 🇰🇷 Goyang-si, Korea, Republic of

Hanyang University Guri Hospital; 🇰🇷 Guri-si, Korea, Republic of

Chung-Ang University Gwangmyeong Hospital; 🇰🇷 Gwangmyeong, Korea, Republic of

The Catholic University of Korea Incheon St. Mary's Hospital; 🇰🇷 Incheon, Korea, Republic of

Jeonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

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