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This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADX-038 Dose Level 1 - IgAN | Experimental |
| |
| ADX-038 Dose Level 1 - C3G | Experimental |
| |
| ADX-038 Dose Level 2 - IgAN | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADX-038 Dose Level 2 | Drug | siRNA duplex oligonucleotide |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of ADX-038 | Incidence and severity of TEAEs | Length of study - 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tracy Nguyen | Contact | 877-232-7974 | info@adarx.com |
| Name | Affiliation | Role |
|---|---|---|
| Aditya Patel, MD | ADARx Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ADARx Clinical Site | Recruiting | Doral | Florida | 33122 | United States | |
| ADARx Clinical Site |
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| ADX-038 Dose Level 1 |
| Drug |
siRNA duplex oligonucleotide |
|
| Recruiting |
| Miami |
| Florida |
| 33127 |
| United States |
| ADARx Clinical Site | Recruiting | Pembroke Pines | Florida | 33029 | United States |
| ADARx Clinical Site | Recruiting | Iowa City | Iowa | 52242 | United States |
| ADARx Clinical Site | Recruiting | Shreveport | Louisiana | 71101 | United States |
| ADARx Clinical Site | Recruiting | Shelby | Michigan | 48315 | United States |
| ADARx Clinical Site | Recruiting | Great Neck | New York | 11021 | United States |
| ADARx Clinical Site | Recruiting | Columbus | Ohio | 43210 | United States |
| ADARx Clinical Site | Recruiting | Dakota Dunes | South Dakota | 57049 | United States |
| ADARx Clinical Site | Recruiting | Dallas | Texas | 75230 | United States |
| ADARx Clinical Site | Recruiting | Houston | Texas | 77027 | United States |
| ADARx Clinical Site | Recruiting | Liverpool | New South Wales | 2170 | Australia |
| ADARx Clinical Site | Recruiting | Wollongong | New South Wales | 2500 | Australia |
| ADARx Clinical Site | Recruiting | Sydney | NSW 2139 | Australia |
| ADARx Clinical Site | Recruiting | Woolloongabba | QLD 4102 | Australia |
| ADARx Clinical Site | Recruiting | Hong Kong | 2500 | Hong Kong |
| ADARx Clinical Site | Recruiting | Shatin | Hong Kong |
| ADARx Clinical Site | Recruiting | Wŏnju | Gangwon-do | 26426 | South Korea |
| ADARx Clinical Site | Recruiting | Cheonan | 31151 | South Korea |
| ADARx Clinical Site | Recruiting | Daegu | 42601 | South Korea |
| ADARx Clinical Site | Recruiting | Gyeonggi-do | 05278 | South Korea |
| ADARx Clinical Site | Recruiting | Seoul | 02841 | South Korea |
| ADARx Clinical Site | Recruiting | Seoul | 03080 | South Korea |
| ADARx Clinical Site | Recruiting | Seoul | 03722 | South Korea |
| ADARx Clinical Site | Recruiting | Seoul | 05278 | South Korea |
| ADARx Clinical Site | Recruiting | Barcelona | 08035 | Spain |
| ADARx Clinical Site | Recruiting | Madrid | 28041 | Spain |
| ADARx Clinical Site | Recruiting | Seville | 41009 | Spain |
| ADARx Clinical Site | Recruiting | Newcastle upon Tyne | UK, NE7 7DN | United Kingdom |
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| 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 |
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