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NCT06989359PHASE2Recruiting

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

ADARx Pharmaceuticals, Inc.

Start Date

8/28/2025

Completion Date

6/1/2029

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

ADX-038 Dose Level 2

DRUG

ADX-038 Dose Level 1

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Conditions

IgANC3GComplement-mediated Kidney DiseaseIgA Nephropathy (IgAN)IC-MPGN

Locations

ADARx Clinical Site

Doral, Florida 33122

United States

ADARx Clinical Site

Miami, Florida 33127

United States

ADARx Clinical Site

Pembroke Pines, Florida 33029

United States

ADARx Clinical Site

Iowa City, Iowa 52242

United States

ADARx Clinical Site

Shreveport, Louisiana 71101

United States

ADARx Clinical Site

Shelby, Michigan 48315

United States

ADARx Clinical Site

Great Neck, New York 11021

United States

ADARx Clinical Site

Columbus, Ohio 43210

United States

ADARx Clinical Site

Dakota Dunes, South Dakota 57049

United States

ADARx Clinical Site

Dallas, Texas 75230

United States

ADARx Clinical Site

Houston, Texas 77027

United States

ADARx Clinical Site

Liverpool, New South Wales 2170

Australia

ADARx Clinical Site

Wollongong, New South Wales 2500

Australia

ADARx Clinical Site

Sydney, NSW 2139

Australia

ADARx Clinical Site

Woolloongabba, QLD 4102

Australia

ADARx Clinical Site

Hong Kong, 2500

Hong Kong

ADARx Clinical Site

Shatin,

Hong Kong

ADARx Clinical Site

Bergamo, 24020

Italy

ADARx Clinical Site

Pavia, 27100

Italy

ADARx Clinical Site

Wŏnju, Gangwon-do 26426

South Korea

ADARx Clinical Site

Gyeonggi-do, Gurogu 16499

South Korea

ADARx Clinical Site

Seoul, Gurogu 08308

South Korea

ADARx Clinical Site

Cheonan, 31151

South Korea

ADARx Clinical Site

Daegu, 42601

South Korea

ADARx Clinical Site

Gyeonggi-do, 05278

South Korea

ADARx Clinical Site

Seoul, 02841

South Korea

ADARx Clinical Site

Seoul, 03080

South Korea

ADARx Clinical Site

Seoul, 03722

South Korea

ADARx Clinical Site

Seoul, 05278

South Korea

ADARx Clinical Site

Barcelona, 08035

Spain

ADARx Clinical Site

Madrid, 28041

Spain

ADARx Clinical Site

Seville, 41009

Spain

ADARx Clinical Site

New Taipei City, 110

Taiwan

ADARx Clinical Site

Newcastle upon Tyne, UK, NE7 7DN

United Kingdom