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Набира участници Фаза 2 NCT06989359

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: IgAN C3G Complement-mediated Kidney Disease IgA Nephropathy (IgAN) IC-MPGN

Спонсор: ADARx Pharmaceuticals, Inc.

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Интервенции
ADX-038 Dose Level 2
DRUG
ADX-038 Dose Level 1
DRUG
Места на провеждане 25
Австралия (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
Южна Корея (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
Испания (1)
ADARx Clinical Site
Madrid
Великобритания (1)
ADARx Clinical Site
Newcastle upon Tyne
САЩ (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
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
28.08.2025
Крайна дата
01.06.2029
Регистрационен номер
NCT06989359
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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