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

Last updated: June 1, 2026
Sponsor: BeOne Medicines
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Nephrotic Syndrome

Idiopathic Membranous Nephropathy

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: 178
Treatment Group(s): 2
Primary Treatment: Tacrolimus
Phase: 2/3
Study Start date:
April 17, 2023
Estimated Completion Date:
October 31, 2027

Study Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Connect with a study center

  • Centro de Investigaciones Madicas Mar Del Plata

    Mar del Plata, 7600
    Argentina

    Completed

  • Instituto Pro Renal Brasil

    Curitiba, 80420-011
    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

    Site Not Available

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

    São Paulo, 05403-000
    Brazil

    Site Not Available

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

    São Paulo 3448439, 05403-000
    Brazil

    Site Not Available

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Suspended

  • Ott Healthcare, Inc (Corporate Medical Centre)

    Scarborough Village, Ontario M1H 3G4
    Canada

    Site Not Available

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

    Vancouver, V6K 2P1
    Canada

    Active - Recruiting

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

    Beijing, Beijing 100029
    China

    Active - Recruiting

  • Peking University Peoples Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • Beijing An Zhen Hospital, Capital Medical University

    Beijing, Beijing Municipality 100029
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, Beijing Municipality 100034
    China

    Site Not Available

  • Peking University First Hospital

    Beijing 1816670, Beijing Municipality 2038349 100034
    China

    Site Not Available

  • Peking University Peoples Hospital

    Beijing 1816670, Beijing Municipality 2038349 100044
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou 1810821, Fujian 1811017 350001
    China

    Site Not Available

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong 518036
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat Sen University

    Guangzhou 1809858, Guangdong 1809935 510080
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Guizhou Provincial Peoples Hospital

    Guiyang, Guizhou 550002
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei 50000
    China

    Site Not Available

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang, Henan 473000
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei 430060
    China

    Site Not Available

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

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wuhan 1791247, Hubei 1806949 430060
    China

    Site Not Available

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia 14017
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu 210009
    China

    Completed

  • Wuxi Peoples Hospital

    Wuxi, Jiangsu 214023
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia 750004
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan, Shandong 250021
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University Branch South

    Qingdao, Shandong 266000
    China

    Site Not Available

  • Weifang Peoples Hospital

    Weifang, Shandong 261000
    China

    Site Not Available

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality 200025
    China

    Site Not Available

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality 200080
    China

    Site Not Available

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai 1796236, Shanghai Municipality 1796231 200025
    China

    Site Not Available

  • Shanxi Provincial Peoples Hospital

    Taiyuan, Shanxi 030012
    China

    Site Not Available

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan 610071
    China

    Site Not Available

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang 830054
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Zhejiang Provincial Peoples Hospital

    Hangzhou, Zhejiang 310014
    China

    Site Not Available

  • Ningbo First Hospital

    Ningbo, Zhejiang 315010
    China

    Active - Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang 315010
    China

    Site Not Available

  • Zhejiang Provincial Peoples Hospital

    Hangzhou 1808926, Zhejiang 1784764 310014
    China

    Site Not Available

  • Fakultni Nemocnice Olomouc

    Olomouc, 77900
    Czechia

    Site Not Available

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 10000
    Czechia

    Site Not Available

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

    Pavia, 27100
    Italy

    Site Not Available

  • Medical Company Llc

    Grozny, Chechenskaya Respublika 364029
    Russia

    Site 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 Kingdom

    Site Not Available

  • Royal Derby Hospital

    Derby, DE22 3NE
    United Kingdom

    Site Not Available

  • Amicis Research Center

    Granada Hills, California 91344
    United States

    Site Not Available

  • Amicis Research Center

    Northridge, California 91324
    United States

    Active - Recruiting

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Intermed Consultants

    Minneapolis, Minnesota 55435-2130
    United States

    Site Not Available

  • Kidney Specialist of Southern Nevada (Ksosn)

    Las Vegas, Nevada 89106-4852
    United States

    Site Not Available

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio 45267-2827
    United States

    Site Not Available

  • Carolina Nephrology

    Spartanburg, South Carolina 29306-3927
    United States

    Site Not Available

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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