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Recruiting
NCT07522099
Chinese Adults With Kidney Disease
Conditions: Immunoglobulin A Nephropathy (IgAN), Complement 3 Glomerulopathy (C3G), IC-MPGN
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 30
Sponsor: ADARx Pharmaceuticals, Inc.
Location: ADARx Clinical Site Shenzhen Guangdong
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 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
Source: ClinicalTrials.gov (NCT07522099). StuddyBuddy aggregates publicly available trial information.