A Phase 2 Study to Assess ADX-038 in Chinese Adults With Complement-Mediated Kidney Disease
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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).
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
Other Locations
China
ADARx Clinical Site
RECRUITING
Baotou
ADARx Clinical Site
RECRUITING
Beijing
ADARx Clinical Site
RECRUITING
Guiyang
ADARx Clinical Site
RECRUITING
Shandong
ADARx Clinical Site
RECRUITING
Shanghai
ADARx Clinical Site
RECRUITING
Shenzhen
ADARx Clinical Site
RECRUITING
Wuxi
ADARx Clinical Site
RECRUITING
Yantai
ADARx Clinical Site
RECRUITING
Zhengzhou
Contact Information
Primary
Stephanie Leyva
info@adarx.com
877-232-7974
Time Frame
Start Date: 2026-05-21
Estimated Completion Date: 2029-01-21
Participants
Target number of participants: 30
Treatments
Experimental: Part A - ADX-038 Monotherapy
Experimental: Part B - ADX-038 Combination Therapy
Related Therapeutic Areas
Sponsors
Leads: ADARx Pharmaceuticals, Inc.