A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Louisiana
ADARx Clinical Site
RECRUITING
Shreveport
Michigan
ADARx Clinical Site
RECRUITING
Shelby
South Dakota
ADARx Clinical Site
RECRUITING
Dakota Dunes
Texas
ADARx Clinical Site
RECRUITING
Dallas
ADARx Clinical Site
RECRUITING
Houston
Other Locations
Australia
ADARx Clinical Site
RECRUITING
Wollongong
Hong Kong Special Administrative Region
ADARx Clinical Site
RECRUITING
Pok Fu Lam
ADARx Clinical Site
RECRUITING
Shatin
Republic of Korea
ADARx Clinical Site
RECRUITING
Cheonan
ADARx Clinical Site
RECRUITING
Gyeonggi-do
ADARx Clinical Site
RECRUITING
Seoul
ADARx Clinical Site
RECRUITING
Seoul
Contact Information
Primary
Lyle Gee
lgee@adarx.com
877-232-7974
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2028-07
Participants
Target number of participants: 45
Treatments
Experimental: ADX-038 Dose Level 1 - IgAN
Experimental: ADX-038 Dose Level 1 - C3G
Experimental: ADX-038 Dose Level 2 - IgAN
Related Therapeutic Areas
Sponsors
Leads: ADARx Pharmaceuticals, Inc.