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Набира участници Фаза 2 NCT07157787

Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Primary Membranous Nephropathy

Спонсор: Alexion Pharmaceuticals, Inc.

Налично на: БГ
Обобщение
The primary objective of this study is to evaluate the efficacy of ALXN1920 compared with placebo in participants with PMN who are at a high risk for disease progression using 24-hour urine protein creatinine ratio (UPCR).
Кой може да участва
Inclusion Criteria: * Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (\> 20 RU/mL) at Screening, which must be confirmed by a central laboratory * Participants are willing to receive the background Standard of Care (SoC) * Participants at high risk for disease progression, defined as: 1. Receiving ACE inhibitor or ARB for a minimum of 8 weeks prior to Screening, with the dose titrated to the maximally tolerated level. Participants with less than 8 weeks on ACE inhibitor or ARB before Screening or who have not yet reached maximally tolerated dose will enter the Run-in Period. 2. Participants who are on ACE inhibitor or ARB for a minimum of 8 weeks with Systolic Blood Pressure \< 140 mmHg in ≥ 75% of the readings within last 8 weeks. 3. Having two proteinuria measurements with each \> 3.5 g/day, the second measurement showing ≤50% decrease from the first measurement. * eGFR60 mL/min/1.73 m2 during Screening calculated by CKD-EPI 2021 creatinine formula * All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis Exclusion Criteria: * Documented rapid deterioration of kidney function * History of life-threatening Nephrotic Syndrome within 1 year before Screening * Diagnosis of anti- phospholipase A2 receptor (PLA2R) negative membranous nephropathy (MN) or anti-PLA2R positive MN but Screening serum anti-PLA2R \< 20 RU/mL or kidney disease other than PMN * History of kidney transplant or planned kidney transplant or dialysis during the Treatment Period * History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant; or planned transplant during the Treatment Period * History or presence of any clinically relevant co-morbidities * History of intolerance or hypersensitivity to ACEi or ARB * Initiation or dose adjustment of SGLT2i within 12 weeks prior to randomization or planned adjustment of GSLT2i dose throughout the treatment period. * Use of traditional Chinese medicines or Chinese proprietary medicines with systemic immunosuppressive properties within 6 months prior to screening. * Use of MRA, or ERA within 12 weeks prior to randomization and throughout the study period Note: Additional inclusion/exclusion criteria may apply, per protocol.
Интервенции
ALXN1920
DRUG
Placebo
DRUG
Места на провеждане 40
Argentina (7)
Research Site
Buenos Aires
Research Site
CABA
Research Site
Ciudad de Buenos Aires
Research Site
La Plata
NOT_YET_RECRUITING
Research Site
Rosario
Research Site
Santa Fe
WITHDRAWN
Research Site
Santa Fe
WITHDRAWN
Австралия (3)
Research Site
Gosford
Research Site
Parkville
Research Site
Southport
Бразилия (4)
Research Site
Recife
Research Site
Salvador
Research Site
São Paulo
Research Site
São Paulo
Китай (4)
Research Site
Baotou
Research Site
Beijing
Research Site
Guangzhou
Research Site
Shenzhen
Франция (3)
Research Site
Créteil
WITHDRAWN
Research Site
Nice
Research Site
Toulouse
Италия (3)
Research Site
Milan
Research Site
Ranica
Research Site
Torrette
Испания (4)
Research Site
Barcelona
Research Site
Madrid
Research Site
Seville
Research Site
Toledo
Taiwan (3)
Research Site
Kaohsiung City
Research Site
Taichung
Research Site
Taoyuan District
Великобритания (4)
Research Site
Cambridge
Research Site
Leicester
Research Site
London
Research Site
Salford
САЩ (5)
Research Site
Houston , Texas
Research Site
Loma Linda , California
Research Site
Minneapolis , Minnesota
Research Site
Rochester , Minnesota
Research Site
San Diego , California
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
19.09.2025
Крайна дата
09.07.2027
Регистрационен номер
NCT07157787
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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