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Recruiting Phase 2 NCT07522099

Chinese Adults With Kidney Disease

Phase 2 – studying effectiveness and dosage
Conditions: Immunoglobulin A Nephropathy (IgAN) Complement 3 Glomerulopathy (C3G) IC-MPGN

Sponsor: ADARx Pharmaceuticals, Inc.

trial.available_in: БГ
Overview
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).
Who can participate
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
Interventions
ADX-038
DRUG
Telitacicept
DRUG
Locations 10
China (10)
ADARx Clinical Site
Baotou , Inner Mongolia
ADARx Clinical Site
Beijing
ADARx Clinical Site
Guiyang , Guizhou
NOT_YET_RECRUITING
ADARx Clinical Site
Shandong
NOT_YET_RECRUITING
ADARx Clinical Site
Shanghai
NOT_YET_RECRUITING
ADARx Clinical Site
Shangxi
NOT_YET_RECRUITING
ADARx Clinical Site
Shenzhen , Guangdong
ADARx Clinical Site
Wuxi , Jiangsu
ADARx Clinical Site
Yantai , Shandong
ADARx Clinical Site
Zhengzhou , Henan
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
23.07.2026
Completion date
21.01.2029
Registry ID
NCT07522099
Source
clinicaltrials.gov
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