Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
Part of paid clinical trials in Doral, Florida.
- Sponsor
- ADARx Pharmaceuticals, Inc.
- Study ID
- NCT06989359
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- C3G
- Complement-mediated Kidney Disease
- IC-MPGN
- IgA Nephropathy (IgAN)
- IgAN
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ADX-038 Dose Level 2 — DRUGsiRNA duplex oligonucleotide
- ADX-038 Dose Level 1 — DRUGsiRNA duplex oligonucleotide
Study Details
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.
Key Dates
- Start date
- Aug 28, 2025
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2028
- Completion
- Jun 30, 2029
Study Design
- Enrollment
- 45 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ADX-038 Dose Level 1 - IgAN
- Experimental: ADX-038 Dose Level 1 - C3G
- Experimental: ADX-038 Dose Level 2 - IgAN
Primary Outcome Measure
Evaluate the safety and tolerability of ADX-038 [ Time Frame: Length of study - 36 months ]
Central Contacts
- Tracy Nguyen877-232-7974
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| ADARx Clinical Site | Doral | Florida | 33122 | - |
| ADARx Clinical Site | Miami | Florida | 33127 | - |
| ADARx Clinical Site | Pembroke Pines | Florida | 33029 | - |
| ADARx Clinical Site | Iowa City | Iowa | 52242 | - |
| ADARx Clinical Site | Shreveport | Louisiana | 71101 | - |
| ADARx Clinical Site | Shelby | Michigan | 48315 | - |
| ADARx Clinical Site | Great Neck | New York | 11021 | - |
| ADARx Clinical Site | Columbus | Ohio | 43210 | - |
| ADARx Clinical Site | Dakota Dunes | South Dakota | 57049 | - |
| ADARx Clinical Site | Dallas | Texas | 75230 | - |
| ADARx Clinical Site | Houston | Texas | 77027 | - |
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