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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004155-37 | EudraCT Number |
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This is a proof of concept (PoC) trial to evaluate the safety, tolerability and renal effect of APX-115 in subjects with Type 2 diabetes and nephropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APX-115 | Experimental | Oral administration of APX-115 400mg, daily |
|
| Placebo | Placebo Comparator | Oral administration of APX-115-matching placebo 400mg, daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APX-115 | Drug | oral administration of APX-115 400mg capsule once daily for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in urine albumin to creatinine ratio (UACR) in APX-115 group compared to placebo group | week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Istavan Wittmann, MD | University of Pecs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pleven | Pleven | Bulgaria | ||||
| Sveta Karidad |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40183134 | Derived | Jang J, Yu H, Oh EB, Park JW, Kim S, Kim T, Sohn J, Jin BR, Chang TS. Targeting NADPH Oxidase with APX-115: Suppression of Platelet Activation and Thrombotic Response. Antioxid Redox Signal. 2025 Aug;43(4-6):288-307. doi: 10.1089/ars.2024.0695. Epub 2025 Apr 4. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 16, 2023 | |
| Unrelease | Aug 23, 2023 |
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| Placebo |
| Drug |
oral administration of APX-115-matching placebo 400mg capsule once daily for 12 weeks |
|
| Plovdiv |
| Bulgaria |
| Diagnostic-consultative centre I | Sliven | Bulgaria |
| Hadzhi Dimitar | Sofia | Bulgaria |
| HERA | Sofia | Bulgaria |
| Medical center - Sveti Dimitar | Sofia | Bulgaria |
| Sirtuin | Sofia | Bulgaria |
| Sveta | Sofia | Bulgaria |
| Hristo Botev | Vratsa | Bulgaria |
| Sveti Panteleymon Yambol | Yambol | Bulgaria |
| Nefromed s.r.o | Prague | Czechia |
| Drug Research Center | Balatonfüred | Hungary |
| UNO MEDICAL Trials Kft. | Budapest | Hungary |
| Mint House Private Medical Center | Székesfehérvár | Hungary |
| Bezanijska Kosa | Belgrade | Serbia |
| Clinical Centre of Serbia, clinic for endocrinology, diabetes and metabolism diseases, department for obesity, metabolic and reproductive disorders | Belgrade | Serbia |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 16, 2023 | Aug 23, 2023 |
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D003924 | Diabetes Mellitus, Type 2 |
| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000620865 | isuzinaxib |
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