Diabetic Kidney Disease (DKD)
Conditions
Keywords
Isuzinaxib, APX-115, NOX, Diabetic Nephropathy, DN, Diabetic Kidney Disease, DKD
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.
Interventions
DRUGIsuzinaxib
Oral dosing regimen once daily
DRUGPlacebo
Oral dosing regimen once daily
Sponsors
Aptabio Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Efficacy endpoint: eGFR | Over 24 Weeks | Change from baseline in the eGFR |
| PK Endpoint: Pharmacokinetics | Over 24 Weeks | Assessment of plasma concentrations of Isuzinaxib |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Over 24 Weeks | Incidence of treatment-emergent adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma Biomarkers | Over 24 Weeks | MCP-1 |
| Urinary Biomarkers | Over 24 Weeks | KIM-1, NGAL |
Countries
South Korea
Contacts
Primary ContactSung Jun Lim
Outcome results
None listed