ADX-038 with or without telitacicept for Chinese adults with IgA nephropathy, C3G, or IC-MPGN
A Phase 2 Study to Assess ADX-038 in Chinese Adults With Complement-Mediated Kidney Disease
This Phase 2 trial will test whether ADX-038, given alone or with telitacicept, is safe and helps Chinese adults with biopsy-confirmed IgA nephropathy, complement 3 glomerulopathy, or immune complex MPGN.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ADARx Pharmaceuticals, Inc. Industry-sponsored |
| Drugs / interventions | eculizumab, ravulizumab |
| Locations | 10 sites (Shenzhen, Guangdong and 9 other locations) |
| Trial ID | NCT07522099 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional study enrolls Chinese adults with biopsy-confirmed IgA nephropathy (IgAN), complement 3 glomerulopathy (C3G), or immune complex membranoproliferative glomerulonephritis (IC-MPGN) who have active kidney disease and eGFR ≥30 mL/min/1.73 m2. Participants will receive ADX-038 alone in Part A or ADX-038 combined with telitacicept in Part B at ADARx clinical sites in China. The trial will collect safety, efficacy, pharmacokinetic, and pharmacodynamic data and monitor kidney function and disease activity over the dosing period. Key exclusions include prior complement inhibitors, prior major organ transplant, prolonged renal replacement therapy, rapidly progressive glomerulonephritis, active systemic infection, and abnormal liver function.
Who should consider this trial
Good fit: Adults in China with biopsy-confirmed IgAN, C3G, or IC-MPGN, active disease, eGFR ≥30 mL/min/1.73 m2, and receiving standard supportive care (including ACE inhibitor or ARB if applicable) are the intended participants.
Not a fit: Patients with prior major organ transplant, prolonged dialysis, rapidly progressive disease, active systemic infections, abnormal liver function, or prior use of C5/CFB inhibitors are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the regimen could reduce disease activity and slow progression of complement-mediated kidney damage in affected patients.
How similar studies have performed: Other therapies targeting the complement system have shown benefit in some complement-mediated kidney diseases, but combining complement-targeting agents with B-cell/BAFF-APRIL blockade like telitacicept is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * Previous kidney transplant or major solid organ transplant * Required renal replacement therapy for more than 72 hours * Rapidly progressive glomerular nephritis or acute kidney injury * History of recurrent invasive infection * Current or previous use of C5 or CFB inhibitors (such as eculizumab, ravulizumab or iptacopan) * Active TB, HIV or other systemic infection * Abnormal liver function
Where this trial is running
Shenzhen, Guangdong and 9 other locations
- ADARx Clinical Site — Shenzhen, Guangdong, China (Recruiting)
- ADARx Clinical Site — Guiyang, Guizhou, China (Recruiting)
- ADARx Clinical Site — Zhengzhou, Henan, China (Not_yet_recruiting)
- ADARx Clinical Site — Baotou, Inner Mongolia, China (Recruiting)
- ADARx Clinical Site — Wuxi, Jiangsu, China (Recruiting)
- ADARx Clinical Site — Yantai, Shandong, China (Recruiting)
- ADARx Clinical Site — Beijing, China (Recruiting)
- ADARx Clinical Site — Shandong, China (Not_yet_recruiting)
- ADARx Clinical Site — Shanghai, China (Not_yet_recruiting)
- ADARx Clinical Site — Shangxi, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Stephanie Leyva
- Email: sleyva@adarx.com
- Phone: 877-232-7974
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.