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Clinical Trials in China / NCT07522099
Recruiting Phase 2

Chinese Adults With Kidney Disease

NCT07522099 · tracked via the Priya Life Science China tracker
Sponsor
ADARx Pharmaceuticals, Inc
Phase
Phase 2
Started
2026-05-21
Last updated
2026-09-03

Condition(s) studied

Immunoglobulin A Nephropathy (IgAN)Complement 3 Glomerulopathy (C3G)IC-MPGN

Investigational drug(s) / intervention(s)

ADX-038Telitacicept →

ADX-038: siRNA duplex oligonucleotide

Telitacicept: fusion protein

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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: * 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

Primary outcome measure(s)

  • Evaluate the safety and tolerability of ADX-038 as a monotherapy and in combination with telitacicept — Part A - 24 Months and Part B - 15 months
    Evaluate the proportion of patients with treatment emergent adverse events (TEAEs) with ADX-038 and telitacicept versus those on ADX-038 alone.

Trial sites (9)

FacilityCityRegionStatus
ADARx Clinical Site Shenzhen Guangdong Recruiting
ADARx Clinical Site Guiyang Guizhou Recruiting
ADARx Clinical Site Zhengzhou Henan Recruiting
ADARx Clinical Site Baotou Inner Mongolia Recruiting
ADARx Clinical Site Wuxi Jiangsu Recruiting
ADARx Clinical Site Yantai Shandong Recruiting
ADARx Clinical Site Beijing China Recruiting
ADARx Clinical Site Shandong China Recruiting
ADARx Clinical Site Shanghai China Recruiting

More ADARx Pharmaceuticals, Inc. trials in China

Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE) Recruiting
STOP-HAE: A Phase 3 Study of ADX-324 in HAE Recruiting

Other trials for the same condition

A Study to Assess the Effects of Zigakibart on IgA Nephropathy. Recruiting
A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) Recruiting
A Study of SGB-9768 in Patients With Complement-mediated Kidney Diseases Active, not recruiting
Efficacy and Safety Study of HS-10542 for IgA Nephropathy Starting soon
A Study of Cizutamig in Patients With Immunoglobulin A Nephropathy Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07522099 on ClinicalTrials.gov ↗ ← All trials in China