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This is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases. The study will enroll Chinese adults with IgA nephropathy, complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study will evaluate ADX-038 administered alone (Part A) and in combination with telitacicept (Part B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - ADX-038 Monotherapy | Experimental |
| |
| Part B - ADX-038 Combination Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADX-038 | Drug | siRNA duplex oligonucleotide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of ADX-038 as a monotherapy and in combination with telitacicept | Evaluate the proportion of patients with treatment emergent adverse events (TEAEs) with ADX-038 and telitacicept versus those on ADX-038 alone. | Part A - 24 Months and Part B - 15 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Leyva | Contact | 877-232-7974 | info@adarx.com |
| Name | Affiliation | Role |
|---|---|---|
| Aditya Patel | ADARx Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ADARx Clinical Site | Recruiting | Shenzhen | Guangdong | 518100 | China | |
| ADARx Clinical Site |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| D015432 | Glomerulonephritis, Membranoproliferative |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C000722462 | telitacicept |
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| Telitacicept | Drug | fusion protein |
|
| Recruiting |
| Guiyang |
| Guizhou |
| China |
| ADARx Clinical Site | Not yet recruiting | Zhengzhou | Henan | China |
| ADARx Clinical Site | Recruiting | Baotou | Inner Mongolia | 014000 | China |
| ADARx Clinical Site | Recruiting | Wuxi | Jiangsu | 214000 | China |
| ADARx Clinical Site | Recruiting | Yantai | Shandong | 264008 | China |
| ADARx Clinical Site | Recruiting | Beijing | 100034 | China |
| ADARx Clinical Site | Recruiting | Shandong | China |
| ADARx Clinical Site | Recruiting | Shanghai | China |
| ADARx Clinical Site | Not yet recruiting | Shangxi | China |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |