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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07522099). StuddyBuddy aggregates publicly available trial information.