Phase
Condition
Idiopathic Membranous Nephropathy
Nephrotic Syndrome
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
Connect with a study center
Investigacion Clinica Aplicada
Buenos Aires, 1865
ArgentinaActive - Recruiting
Centro de Investigaciones Madicas Mar Del Plata
Mar del Plata, 7600
ArgentinaActive - Recruiting
Cer San Juan Centro Polivalente de Asistencia E Investigacian Clanica
San Juan, 5400
ArgentinaSite Not Available
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucuman, 4000
ArgentinaSite Not Available
Instituto Pro Renal Brasil
Curitiba, 80240220
BrazilActive - Recruiting
Clipem Clinica E Pesquisa Em Endocrinologia de Maringa
Maringa, 87000-000
BrazilSite Not Available
Hospital Das Clnicas Da Universidade Federal de Pernambuco
Recife, 50000-000
BrazilSite Not Available
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
Ribeirao Preto, 14051140
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
BrazilActive - Recruiting
Hospital Alemao Oswaldo Cruz
Sao Paulo, 04829-310
BrazilSite Not Available
Hospital Do Rim Fundacao Oswaldo Ramos
Sao Paulo, 04038-002
BrazilActive - Recruiting
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9
CanadaSuspended
Chum (Centre Hospitalier de Luniversite de Montreal) Centre de Recherche
Montreal, H2X 3E4
CanadaActive - Recruiting
Chum Centre de Recherche
Montreal, H2X 3E4
CanadaSite Not Available
Cisss de La Monteregie Centre
Quebec, G1S 1L7
CanadaSite Not Available
Ott Healthcare, Inc
Scarborough, M1H 3G4
CanadaSite Not Available
Ott Healthcare, Inc (Corporate Medical Centre)
Scarborough, M1H 3G4
CanadaActive - Recruiting
University of British Columbia
Vancouver, V6K 2P1
CanadaSite Not Available
University of British Columbia (Providence Health Care Research St Pauls Hospital)
Vancouver, V6K 2P1
CanadaActive - Recruiting
Fuyang Peoples Hospital
Fuyang, Anhui 236000
ChinaSite Not Available
Beijing An Zhen Hospital of the Capital University of Medical Sciences
Beijing, Beijing 100029
ChinaActive - Recruiting
Beijing An Zhen Hospital, Capital Medical University
Beijing, Beijing 100029
ChinaActive - Recruiting
Peking University First Hospital
Beijing, Beijing 100034
ChinaActive - Recruiting
Peking University Peoples Hospital
Beijing, Beijing 100044
ChinaActive - Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaSite Not Available
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian 350005
ChinaActive - Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian 361003
ChinaActive - Recruiting
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong 510080
ChinaActive - Recruiting
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong 510080
ChinaActive - Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong 518036
ChinaActive - Recruiting
Liuzhou Peoples Hospital
Liuzhou, Guangxi 545006
ChinaSite Not Available
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi 530021
ChinaActive - Recruiting
Guizhou Provincial Peoples Hospital
Guiyang, Guizhou 550002
ChinaActive - Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei 50000
ChinaActive - Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang 150001
ChinaSite Not Available
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan 471003
ChinaSite Not Available
Nanyang Central Hospital
Nanyang, Henan 473000
ChinaActive - Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan 453100
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450052
ChinaActive - Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei 430060
ChinaActive - Recruiting
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei 430030
ChinaActive - Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan 410008
ChinaActive - Recruiting
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia 14017
ChinaActive - Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu 210029
ChinaActive - Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu 210009
ChinaCompleted
Wuxi Peoples Hospital
Wuxi, Jiangsu 214023
ChinaActive - Recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu 212001
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi 332000
ChinaSite Not Available
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning 116011
ChinaCompleted
Shengjing Hospital of China Medical University
Shenyang, Liaoning 110004
ChinaCompleted
General Hospital of Ningxia Medical University
Yinchuan, Ningxia 750004
ChinaActive - Recruiting
Shandong Provincial Hospital
Jinan, Shandong 250021
ChinaActive - Recruiting
Affiliated Hospital of Jining Medical University
Jining, Shandong 272000
ChinaSite Not Available
The Affiliated Hospital of Qingdao University Branch South
Qingdao, Shandong 266000
ChinaActive - Recruiting
Weifang Peoples Hospital
Weifang, Shandong 261000
ChinaSite Not Available
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai 200025
ChinaActive - Recruiting
Shanghai General Hospital
Shanghai, Shanghai 200080
ChinaActive - Recruiting
Shanxi Provincial Peoples Hospital
Taiyuan, Shanxi 030012
ChinaActive - Recruiting
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan 610071
ChinaActive - Recruiting
Zigong First Peoples Hospital, Zigong Academy of Medical Sciences
Zigong, Sichuan 643002
ChinaSite Not Available
Tianjin Union Medical Center (Nankai University Affiliated Hospital)
Tianjin, Tianjin 300121
ChinaSite Not Available
The First Affiliated Hospital of Xinjiang Medical University
Urumqi, Xinjiang 830054
ChinaActive - Recruiting
The First Peoples Hospital of Yunnan Province
Kunming, Yunnan 650034
ChinaCompleted
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang 310014
ChinaActive - Recruiting
Ningbo First Hospital
Ningbo, Zhejiang 315010
ChinaActive - Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang 315010
ChinaActive - Recruiting
Fakultni Nemocnice Olomouc
Olomouc, 77900
CzechiaActive - Recruiting
Vseobecna Fakultni Nemocnice V Praze
Praha, 10000
CzechiaActive - Recruiting
Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
Bologna, 40138
ItalyCompleted
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, 25123
ItalyCompleted
Istscientifico Di Pavia, Fondazione Smaugeri, Irccs, Clinica Del Lavoro E Della Riabilitazione
Pavia, 27100
ItalyActive - Recruiting
Centenario Hospital Miguel Hidalgo
Aguascalientes, 2008
MexicoSite Not Available
Hospital Angeles Chihuahua
Chihuahua, 31104
MexicoSite Not Available
Morales Vargas Centro de Investigacion Sc
Leon, 36090
MexicoSite Not Available
IECSI
Monterrey, 64310
MexicoSite Not Available
Spzoz Centralny Szpital Kliniczny Um W Lodzi
Lodz, 92-213
PolandActive - Recruiting
Wojewodzki Specjalistyczny Szpital W Olsztynie
Olsztyn, 10-561
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw, 50-556
PolandSite Not Available
Fundacion Puigvert
Barcelona, 08025
SpainSite Not Available
Hospital Universitario Vall Dhebron
Barcelona, 08035
SpainSite Not Available
Hospital Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Hospital Universitario Virgen Del Rocio
Sevilla, 41013
SpainSite Not Available
Erciyes University Medical Faculty
Erciyes, 38030
TurkeyActive - Recruiting
Kocaeli University Research and Application Hospital Department of Nephrology
Kocaeli, 41380
TurkeyActive - Recruiting
Kahramanmaras Sutcu Imam University
Onikiubat, 46050
TurkeySite Not Available
St Heliers Hospital
Sutton, Carlshalton SM5 1AA
United KingdomSite Not Available
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
United KingdomActive - Recruiting
St Heliers Hospital
Carlshalton, SM5 1AA
United KingdomActive - Recruiting
Royal Derby Hospital
Derby, DE22 3NE
United KingdomActive - Recruiting
Aintree University Hospital
Liverpool, L9 7AL
United KingdomActive - Recruiting
Hammersmith Hospital
London, W12 0HS
United KingdomSite Not Available
Manchester Royal Infirmary
Manchester, M13 9WL
United KingdomActive - Recruiting
Renal Associates of Alabama, Llc
Montgomery, Alabama 36117
United StatesSite Not Available
Amicis Research Center
Northridge, California 91324
United StatesActive - Recruiting
Stanford University
Palo Alto, California 94304
United StatesActive - Recruiting
University of California At San Francisco
San Francisco, California 94143
United StatesSite Not Available
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesSite Not Available
Renal Associates, Llc
Columbus, Georgia 31904
United StatesSite Not Available
Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
United StatesActive - Recruiting
Northshore University Healthsystem
Evanston, Illinois 60201
United StatesActive - Recruiting
Intermed Consultants
Edina, Minnesota 55435
United StatesActive - Recruiting
Kidney Specialist of Southern Nevada (Ksosn)
Las Vegas, Nevada 89106
United StatesActive - Recruiting
Donald and Barbara Zucker School of Medicine At Northwell Health
Great Neck, New York 11021
United StatesSite Not Available
Columbia University Irving Medical Center
New York, New York 10032
United StatesSite Not Available
Cardinal Clinical Research, Llc
Rutherfordton, North Carolina 28139
United StatesSite Not Available
University of Cincinnati Cancer Center
Cincinnati, Ohio 45267
United StatesSite Not Available
University of Cincinnati College of Medicine
Cincinnati, Ohio 45267
United StatesActive - Recruiting
Carolina Nephrology
Spartanburg, South Carolina 29306
United StatesActive - Recruiting
Prolato Clinical Research Center
Houston, Texas 77054
United StatesActive - Recruiting
San Antonio Kidney Disease Center Physicians Group, Pllc Medical Center
San Antonio, Texas 78229
United StatesSite Not Available
Kidney Specialists of North Houston
Shenandoah, Texas 77384
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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