A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease
ADARx Pharmaceuticals, Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Mean eGFR greater than or equal to 30 mL/min/1.73m2 * Clinical evidence of active kidney disease * Treated with supportive care including an ACE inhibitor or ARB if applicable * Willing to receive required vaccinations * Primary diagnosis of IgAN, C3G or IC-MPGN confirmed by a kidney biopsy Exclusion Criteria: * Hereditary or acquired complement deficiency * Kidney transplant or renal replacement therapy * History of solid organ transplant * Other kidney disease * History of recurrent invasive infections * Received complement inhibitor treatments * Active systemic vira…
Interventions
- DrugADX-038 Dose Level 2
siRNA duplex oligonucleotide
- DrugADX-038 Dose Level 1
siRNA duplex oligonucleotide
Locations (25)
- ADARx Clinical SiteDoral, Florida
- ADARx Clinical SiteMiami, Florida
- ADARx Clinical SitePembroke Pines, Florida
- ADARx Clinical SiteIowa City, Iowa
- ADARx Clinical SiteShreveport, Louisiana
- ADARx Clinical SiteShelby, Michigan