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Recruiting Phase 2 NCT06989359

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

Phase 2 – studying effectiveness and dosage
Conditions: IgAN C3G Complement-mediated Kidney Disease IgA Nephropathy (IgAN) IC-MPGN

Sponsor: ADARx Pharmaceuticals, Inc.

trial.available_in: БГ
Overview
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.
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: * 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
ADX-038 Dose Level 2
DRUG
ADX-038 Dose Level 1
DRUG
Locations 25
Australia (3)
ADARx Clinical Site
Sydney
ADARx Clinical Site
Wollongong , New South Wales
ADARx Clinical Site
Woolloongabba
Hong Kong (2)
ADARx Clinical Site
Hong Kong
ADARx Clinical Site
Shatin
South Korea (7)
ADARx Clinical Site
Cheonan
ADARx Clinical Site
Daegu
ADARx Clinical Site
Gyeonggi-do
ADARx Clinical Site
Seoul
ADARx Clinical Site
Seoul
ADARx Clinical Site
Seoul
ADARx Clinical Site
Seoul
Spain (1)
ADARx Clinical Site
Madrid
United Kingdom (1)
ADARx Clinical Site
Newcastle upon Tyne
United States (11)
ADARx Clinical Site
Columbus , Ohio
ADARx Clinical Site
Dakota Dunes , South Dakota
ADARx Clinical Site
Dallas , Texas
ADARx Clinical Site
Doral , Florida
ADARx Clinical Site
Great Neck , New York
ADARx Clinical Site
Houston , Texas
ADARx Clinical Site
Iowa City , Iowa
ADARx Clinical Site
Miami , Florida
ADARx Clinical Site
Pembroke Pines , Florida
ADARx Clinical Site
Shelby , Michigan
ADARx Clinical Site
Shreveport , Louisiana
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
28.08.2025
Completion date
01.06.2029
Registry ID
NCT06989359
Source
clinicaltrials.gov
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