Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease

Conditions: IgAN, C3G, Complement-mediated Kidney Disease, IgA Nephropathy (IgAN), IC-MPGN

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE2

Enrollment: 45

Sponsor: ADARx Pharmaceuticals, Inc.

Summary

This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.

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: * Hereditary or acquired complement deficiency * Kidney transplant or renal replacement therapy * History of solid organ transplant * Other kidney disease * History of recurrent invasive infections * Received complement inhibitor treatments * Active systemic viral, bacterial, or fungal infection * Abnormal liver function

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

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06989359). StuddyBuddy aggregates publicly available trial information.