Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isuzinaxib 400 mg | Active Comparator | Subject will receive the 400 mg of Isuzinaxib. |
|
| Isuzinaxib 200 mg | Active Comparator | Subject will receive the 200 mg of Isuzinaxib. |
|
| Placebo | Placebo Comparator | Subject will receive the Placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isuzinaxib | Drug | Oral dosing regimen once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoint: Urine Albumin-Creatinine Ratio | Change in Urine Albumin-Creatinine Ratio from baseline through Week 24 in the Isuzinaxib treatment groups versus the placebo group | Over 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoint: eGFR | Change from baseline in the eGFR | Over 24 Weeks |
| Efficacy endpoint: Urine Albumin-Creatinine Ratio | Change in Urine Albumin-Creatinine Ratio from baseline through Week 20 in the Isuzinaxib treatment groups versus the placebo group |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Biomarkers | MCP-1 | Over 24 Weeks |
| Urinary Biomarkers | KIM-1, NGAL | Over 24 Weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sung Jun Lim | Contact | +82-31-365-3693 | cd@aptabio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Recruiting | Ansan-si | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Oral dosing regimen once daily |
|
| Over 20 Weeks |
| Efficacy endpoint: Urine Albumin-Creatinine Ratio decrease | Subjects with a percentage decrease in Urine Albumin-Creatinine Ratio | Over 24 Weeks |
| Efficacy endpoint: Incidence of Composite Renal Outcome | Number of subjects with end-stage kidney disease, kidney-related death, or renal replacement therapy | Over 24 Weeks |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of treatment-emergent adverse events | Over 24 Weeks |
| PK Endpoint: Pharmacokinetics | Assessment of plasma concentrations of Isuzinaxib | Over 24 Weeks |
| Inje university Busan Paik Hospital | Not yet recruiting | Busan | South Korea |
|
| Pusan National University Hospital | Recruiting | Busan | South Korea |
|
| SoonChunHyang University Hospital Cheonan | Recruiting | Cheonan | South Korea |
|
| Keimyung University Daegu Dongsan Hospital | Recruiting | Daegu | South Korea |
|
| Inje university Ilsan Paik Hospital | Recruiting | Goyang-si | South Korea |
|
| Hanyang University Guri Hospital | Recruiting | Guri-si | South Korea |
|
| Chung-Ang University Gwangmyeong Hospital | Recruiting | Gwangmyeong | South Korea |
|
| The Catholic University of Korea Incheon St. Mary's Hospital | Recruiting | Incheon | South Korea |
|
| Jeonbuk National University Hospital | Not yet recruiting | Jeonju | South Korea |
|
| CHA Bundang Medical Center | Recruiting | Seongnam-si | South Korea |
|
| Boramae Medical Center | Recruiting | Seoul | South Korea |
|
| Korea University Guro Hospital | Recruiting | Seoul | South Korea |
|
| Kyung Hee University Hospital at Gangdon | Recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| Severance Hospital | Recruiting | Seoul | South Korea |
|
| The Catholic University of Korea Seoul ST.MARY'S Hospital | Recruiting | Seoul | South Korea |
|
| The Catholic University of Korea Uijeongbu St. Mary's Hospital | Recruiting | Uijeongbu-si | South Korea |
|
| Wonju Severance Christian Hospital | Not yet recruiting | Wŏnju | South Korea |
|
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | South Korea |
|
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000620865 | isuzinaxib |
Not provided
Not provided
Not provided