Phase
Condition
Nephrotic Syndrome
Idiopathic Membranous Nephropathy
Glomerulonephritis
Treatment
Tacrolimus
Zanubrutinib
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Biopsy-confirmed PMN within 5 years before the initial screening (ie, the day theinformed consent is signed)
UPCR (based on 24-hour urine collection) > 3.5 at initial screening and atconfirmation assessment
Treatment with a maximally tolerated or allowed dose of an angiotensin-convertingenzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) for ≥ 24 weeksbefore randomization (12 weeks before initiation of study drug for Part 1) and withadequate blood pressure control (blood pressure < 130/80 mmHg, measured on ≥ 2occasions [not on the same day] within 4 weeks before the assignment of studytreatment)
Anti-PLA2R antibody > 50 RU/mL at confirmation assessment (Part 1 only)
Exclusion
Exclusion Criteria:
Participants with a secondary cause of membranous nephropathy
Type 1 or 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥ 7% at screening
Severe renal disease as determined by rapid decline in eGFR (defined as > 15mL/min/1.73m^2 within 24 weeks prior to randomization, not otherwise explained)
A known history of a primary immunodeficiency or an underlying condition such ashuman immunodeficiency virus (HIV) infection or splenectomy that predisposes theparticipant to infections
Patients at risk for tuberculosis at screening
Known infection with serologic status reflecting active or chronic hepatitis B virusinfection, or presence of hepatitis C virus antibody
Severe hepatic insufficiency (Child-Pugh C)
Clinically significant cardio-cerebrovascular diseases
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Centro de Investigaciones Madicas Mar Del Plata
Mar del Plata, 7600
ArgentinaCompleted
Instituto Pro Renal Brasil
Curitiba, 80420-011
BrazilSite Not Available
Ruschel Medicina E Pesquisa Clinica
Rio de Janeiro, 22270060
BrazilActive - Recruiting
Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo
Sao Paulo, 05403-000
BrazilSite Not Available
Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo
São Paulo, 05403-000
BrazilSite Not Available
Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo
São Paulo 3448439, 05403-000
BrazilSite Not Available
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9
CanadaSuspended
Ott Healthcare, Inc (Corporate Medical Centre)
Scarborough Village, Ontario M1H 3G4
CanadaSite Not Available
University of British Columbia (Providence Health Care Research St Pauls Hospital)
Vancouver, V6K 2P1
CanadaActive - Recruiting
Beijing An Zhen Hospital of the Capital University of Medical Sciences
Beijing, Beijing 100029
ChinaActive - Recruiting
Peking University Peoples Hospital
Beijing, Beijing 100044
ChinaActive - Recruiting
Beijing An Zhen Hospital, Capital Medical University
Beijing, Beijing Municipality 100029
ChinaSite Not Available
Peking University First Hospital
Beijing, Beijing Municipality 100034
ChinaSite Not Available
Peking University First Hospital
Beijing 1816670, Beijing Municipality 2038349 100034
ChinaSite Not Available
Peking University Peoples Hospital
Beijing 1816670, Beijing Municipality 2038349 100044
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaSite Not Available
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian 350005
ChinaSite Not Available
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian 361003
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou 1810821, Fujian 1811017 350001
ChinaSite Not Available
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong 510080
ChinaSite Not Available
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong 510080
ChinaSite Not Available
Peking University Shenzhen Hospital
Shenzhen, Guangdong 518036
ChinaSite Not Available
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou 1809858, Guangdong 1809935 510080
ChinaSite Not Available
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi 530021
ChinaSite Not Available
Guizhou Provincial Peoples Hospital
Guiyang, Guizhou 550002
ChinaSite Not Available
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei 50000
ChinaSite Not Available
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang 150001
ChinaSite Not Available
Nanyang Central Hospital
Nanyang, Henan 473000
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450052
ChinaSite Not Available
Renmin Hospital of Wuhan University
Wuhan, Hubei 430060
ChinaSite Not Available
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei 430030
ChinaSite Not Available
Renmin Hospital of Wuhan University
Wuhan 1791247, Hubei 1806949 430060
ChinaSite Not Available
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia 14017
ChinaSite Not Available
Jiangsu Province Hospital
Nanjing, Jiangsu 210029
ChinaSite Not Available
Zhongda Hospital Southeast University
Nanjing, Jiangsu 210009
ChinaCompleted
Wuxi Peoples Hospital
Wuxi, Jiangsu 214023
ChinaSite Not Available
General Hospital of Ningxia Medical University
Yinchuan, Ningxia 750004
ChinaSite Not Available
Shandong Provincial Hospital
Jinan, Shandong 250021
ChinaSite Not Available
The Affiliated Hospital of Qingdao University Branch South
Qingdao, Shandong 266000
ChinaSite Not Available
Weifang Peoples Hospital
Weifang, Shandong 261000
ChinaSite Not Available
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality 200025
ChinaSite Not Available
Shanghai General Hospital
Shanghai, Shanghai Municipality 200080
ChinaSite Not Available
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai 1796236, Shanghai Municipality 1796231 200025
ChinaSite Not Available
Shanxi Provincial Peoples Hospital
Taiyuan, Shanxi 030012
ChinaSite Not Available
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan 610071
ChinaSite Not Available
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang 830054
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
ChinaSite Not Available
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang 310014
ChinaSite Not Available
Ningbo First Hospital
Ningbo, Zhejiang 315010
ChinaActive - Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang 315010
ChinaSite Not Available
Zhejiang Provincial Peoples Hospital
Hangzhou 1808926, Zhejiang 1784764 310014
ChinaSite Not Available
Fakultni Nemocnice Olomouc
Olomouc, 77900
CzechiaSite Not Available
Vseobecna Fakultni Nemocnice V Praze
Prague, 10000
CzechiaSite Not Available
Istscientifico Di Pavia, Fondazione Smaugeri, Irccs, Clinica Del Lavoro E Della Riabilitazione
Pavia, 27100
ItalySite Not Available
Medical Company Llc
Grozny, Chechenskaya Respublika 364029
RussiaSite Not Available
Erciyes University Medical Faculty
Erciyes, 38030
Turkey (Türkiye)Site Not Available
Kocaeli University Research and Application Hospital Department of Nephrology
Kocaeli, 41380
Turkey (Türkiye)Site Not Available
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
United KingdomSite Not Available
Royal Derby Hospital
Derby, DE22 3NE
United KingdomSite Not Available
Amicis Research Center
Granada Hills, California 91344
United StatesSite Not Available
Amicis Research Center
Northridge, California 91324
United StatesActive - Recruiting
Stanford University
Palo Alto, California 94304
United StatesSite Not Available
Intermed Consultants
Minneapolis, Minnesota 55435-2130
United StatesSite Not Available
Kidney Specialist of Southern Nevada (Ksosn)
Las Vegas, Nevada 89106-4852
United StatesSite Not Available
University of Cincinnati College of Medicine
Cincinnati, Ohio 45267-2827
United StatesSite Not Available
Carolina Nephrology
Spartanburg, South Carolina 29306-3927
United StatesSite Not Available
Prolato Clinical Research Center
Houston, Texas 77054
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting

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