A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy

Last updated: March 21, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

2/3

Condition

Idiopathic Membranous Nephropathy

Nephrotic Syndrome

Glomerulonephritis

Treatment

Tacrolimus

Zanubrutinib

Clinical Study ID

NCT05707377
BGB-3111-309
CTR20230546
2022-501147-32-00
  • Ages 18-75
  • All Genders

Study Summary

The primary objectives of this study are: In Part 1 to evaluate the efficacy of zanubrutinib as measured by proteinuria reduction, and in Part 2 to evaluate the efficacy of zanubrutinib compared with tacrolimus as measured by complete remission rate, in participants with primary membranous nephropathy (PMN) who are on optimal supportive care.

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

Total Participants: 282
Treatment Group(s): 2
Primary Treatment: Tacrolimus
Phase: 2/3
Study Start date:
April 17, 2023
Estimated Completion Date:
April 30, 2028

Connect with a study center

  • Investigacion Clinica Aplicada

    Buenos Aires, 1865
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Madicas Mar Del Plata

    Mar del Plata, 7600
    Argentina

    Active - Recruiting

  • Cer San Juan Centro Polivalente de Asistencia E Investigacian Clanica

    San Juan, 5400
    Argentina

    Site Not Available

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucuman, 4000
    Argentina

    Site Not Available

  • Instituto Pro Renal Brasil

    Curitiba, 80240220
    Brazil

    Active - Recruiting

  • Clipem Clinica E Pesquisa Em Endocrinologia de Maringa

    Maringa, 87000-000
    Brazil

    Site Not Available

  • Hospital Das Clnicas Da Universidade Federal de Pernambuco

    Recife, 50000-000
    Brazil

    Site Not Available

  • Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp

    Ribeirao Preto, 14051140
    Brazil

    Site Not Available

  • Ruschel Medicina E Pesquisa Clinica

    Rio de Janeiro, 22270060
    Brazil

    Active - Recruiting

  • Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo

    Sao Paulo, 05403-000
    Brazil

    Active - Recruiting

  • Hospital Alemao Oswaldo Cruz

    Sao Paulo, 04829-310
    Brazil

    Site Not Available

  • Hospital Do Rim Fundacao Oswaldo Ramos

    Sao Paulo, 04038-002
    Brazil

    Active - Recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Suspended

  • Chum (Centre Hospitalier de Luniversite de Montreal) Centre de Recherche

    Montreal, H2X 3E4
    Canada

    Active - Recruiting

  • Chum Centre de Recherche

    Montreal, H2X 3E4
    Canada

    Site Not Available

  • Cisss de La Monteregie Centre

    Quebec, G1S 1L7
    Canada

    Site Not Available

  • Ott Healthcare, Inc

    Scarborough, M1H 3G4
    Canada

    Site Not Available

  • Ott Healthcare, Inc (Corporate Medical Centre)

    Scarborough, M1H 3G4
    Canada

    Active - Recruiting

  • University of British Columbia

    Vancouver, V6K 2P1
    Canada

    Site Not Available

  • University of British Columbia (Providence Health Care Research St Pauls Hospital)

    Vancouver, V6K 2P1
    Canada

    Active - Recruiting

  • Fuyang Peoples Hospital

    Fuyang, Anhui 236000
    China

    Site Not Available

  • Beijing An Zhen Hospital of the Capital University of Medical Sciences

    Beijing, Beijing 100029
    China

    Active - Recruiting

  • Beijing An Zhen Hospital, Capital Medical University

    Beijing, Beijing 100029
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Active - Recruiting

  • Peking University Peoples Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Active - Recruiting

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong 518036
    China

    Active - Recruiting

  • Liuzhou Peoples Hospital

    Liuzhou, Guangxi 545006
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi 530021
    China

    Active - Recruiting

  • Guizhou Provincial Peoples Hospital

    Guiyang, Guizhou 550002
    China

    Active - Recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei 50000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan 471003
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang, Henan 473000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan 453100
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei 430060
    China

    Active - Recruiting

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan 410008
    China

    Active - Recruiting

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia 14017
    China

    Active - Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu 210009
    China

    Completed

  • Wuxi Peoples Hospital

    Wuxi, Jiangsu 214023
    China

    Active - Recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Xianghu

    Nanchang, Jiangxi 332000
    China

    Site Not Available

  • First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning 116011
    China

    Completed

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110004
    China

    Completed

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia 750004
    China

    Active - Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong 250021
    China

    Active - Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong 272000
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University Branch South

    Qingdao, Shandong 266000
    China

    Active - Recruiting

  • Weifang Peoples Hospital

    Weifang, Shandong 261000
    China

    Site Not Available

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai 200080
    China

    Active - Recruiting

  • Shanxi Provincial Peoples Hospital

    Taiyuan, Shanxi 030012
    China

    Active - Recruiting

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan 610071
    China

    Active - Recruiting

  • Zigong First Peoples Hospital, Zigong Academy of Medical Sciences

    Zigong, Sichuan 643002
    China

    Site Not Available

  • Tianjin Union Medical Center (Nankai University Affiliated Hospital)

    Tianjin, Tianjin 300121
    China

    Site Not Available

  • The First Affiliated Hospital of Xinjiang Medical University

    Urumqi, Xinjiang 830054
    China

    Active - Recruiting

  • The First Peoples Hospital of Yunnan Province

    Kunming, Yunnan 650034
    China

    Completed

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • Zhejiang Provincial Peoples Hospital

    Hangzhou, Zhejiang 310014
    China

    Active - Recruiting

  • Ningbo First Hospital

    Ningbo, Zhejiang 315010
    China

    Active - Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang 315010
    China

    Active - Recruiting

  • Fakultni Nemocnice Olomouc

    Olomouc, 77900
    Czechia

    Active - Recruiting

  • Vseobecna Fakultni Nemocnice V Praze

    Praha, 10000
    Czechia

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

    Bologna, 40138
    Italy

    Completed

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123
    Italy

    Completed

  • Istscientifico Di Pavia, Fondazione Smaugeri, Irccs, Clinica Del Lavoro E Della Riabilitazione

    Pavia, 27100
    Italy

    Active - Recruiting

  • Centenario Hospital Miguel Hidalgo

    Aguascalientes, 2008
    Mexico

    Site Not Available

  • Hospital Angeles Chihuahua

    Chihuahua, 31104
    Mexico

    Site Not Available

  • Morales Vargas Centro de Investigacion Sc

    Leon, 36090
    Mexico

    Site Not Available

  • IECSI

    Monterrey, 64310
    Mexico

    Site Not Available

  • Spzoz Centralny Szpital Kliniczny Um W Lodzi

    Lodz, 92-213
    Poland

    Active - Recruiting

  • Wojewodzki Specjalistyczny Szpital W Olsztynie

    Olsztyn, 10-561
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

    Wroclaw, 50-556
    Poland

    Site Not Available

  • Fundacion Puigvert

    Barcelona, 08025
    Spain

    Site Not Available

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Erciyes University Medical Faculty

    Erciyes, 38030
    Turkey

    Active - Recruiting

  • Kocaeli University Research and Application Hospital Department of Nephrology

    Kocaeli, 41380
    Turkey

    Active - Recruiting

  • Kahramanmaras Sutcu Imam University

    Onikiubat, 46050
    Turkey

    Site Not Available

  • St Heliers Hospital

    Sutton, Carlshalton SM5 1AA
    United Kingdom

    Site Not Available

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN
    United Kingdom

    Active - Recruiting

  • St Heliers Hospital

    Carlshalton, SM5 1AA
    United Kingdom

    Active - Recruiting

  • Royal Derby Hospital

    Derby, DE22 3NE
    United Kingdom

    Active - Recruiting

  • Aintree University Hospital

    Liverpool, L9 7AL
    United Kingdom

    Active - Recruiting

  • Hammersmith Hospital

    London, W12 0HS
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary

    Manchester, M13 9WL
    United Kingdom

    Active - Recruiting

  • Renal Associates of Alabama, Llc

    Montgomery, Alabama 36117
    United States

    Site Not Available

  • Amicis Research Center

    Northridge, California 91324
    United States

    Active - Recruiting

  • Stanford University

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • University of California At San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Renal Associates, Llc

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northshore University Healthsystem

    Evanston, Illinois 60201
    United States

    Active - Recruiting

  • Intermed Consultants

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • Kidney Specialist of Southern Nevada (Ksosn)

    Las Vegas, Nevada 89106
    United States

    Active - Recruiting

  • Donald and Barbara Zucker School of Medicine At Northwell Health

    Great Neck, New York 11021
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Cardinal Clinical Research, Llc

    Rutherfordton, North Carolina 28139
    United States

    Site Not Available

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • Carolina Nephrology

    Spartanburg, South Carolina 29306
    United States

    Active - Recruiting

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Active - Recruiting

  • San Antonio Kidney Disease Center Physicians Group, Pllc Medical Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Kidney Specialists of North Houston

    Shenandoah, Texas 77384
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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