A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy
NCT ID: NCT05707377
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
178 participants
INTERVENTIONAL
2023-04-17
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: Zanubrutinib High Dose
Participants will receive zanubrutinib twice daily.
Zanubrutinib
Zanubrutinib capsules administered orally.
Part 2: Zanubrutinib High Dose
Participants will receive zanubrutinib twice daily.
Zanubrutinib
Zanubrutinib capsules administered orally.
Part 2: Zanubrutinib Low Dose
Participants will receive zanubrutinib once daily.
Zanubrutinib
Zanubrutinib capsules administered orally.
Part 2: Tacrolimus
Participants will receive tacrolimus capsules twice daily for 64 weeks.
Tacrolimus
Tacrolimus capsules administered orally.
Interventions
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Zanubrutinib
Zanubrutinib capsules administered orally.
Tacrolimus
Tacrolimus capsules administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* UPCR (based on 24-hour urine collection) \> 3.5 at initial screening and at confirmation assessment
* Treatment with a maximally tolerated or allowed dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) for ≥ 24 weeks before randomization (12 weeks before initiation of study drug for Part 1) and with adequate blood pressure control (blood pressure \< 130/80 mmHg, measured on ≥ 2 occasions \[not on the same day\] within 4 weeks before the assignment of study treatment)
* Anti-PLA2R antibody \> 50 RU/mL at confirmation assessment (Part 1 only)
Exclusion Criteria
* 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 \> 15 mL/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 as human immunodeficiency virus (HIV) infection or splenectomy that predisposes the participant to infections
* Patients at risk for tuberculosis at screening
* Known infection with serologic status reflecting active or chronic hepatitis B virus infection, or presence of hepatitis C virus antibody
* Severe hepatic insufficiency (Child-Pugh C)
* Clinically significant cardio-cerebrovascular diseases
18 Years
75 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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Amicis Research Center
Northridge, California, United States
Stanford University
Palo Alto, California, United States
Intermed Consultants
Minneapolis, Minnesota, United States
Kidney Specialist of Southern Nevada (Ksosn)
Las Vegas, Nevada, United States
Carolina Nephrology
Spartanburg, South Carolina, United States
Investigacion Clinica Aplicada
Ciudad Autonoma Buenos Aires, , Argentina
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, , Argentina
Instituto Pro Renal Brasil
Curitiba, , Brazil
Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo
São Paulo, , Brazil
Ott Healthcare, Inc (Corporate Medical Centre)
Scarborough Village, Ontario, Canada
Beijing An Zhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Liuzhou Peoples Hospital
Liuzhou, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Guizhou Provincial Peoples Hospital
Guiyang, Guizhou, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shandong Provincial Hospital
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
The Affiliated Hospital of Qingdao University Branch South
Qingdao, Shandong, China
Weifang Peoples Hospital
Weifang, Shandong, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanxi Provincial Peoples Hospital
Taiyuan, Shanxi, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China
Zigong First Peoples Hospital, Zigong Academy of Medical Sciences
Zigong, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Fakultni Nemocnice Olomouc
Olomouc, , Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, , Czechia
Istscientifico Di Pavia, Fondazione Smaugeri, Irccs, Clinica Del Lavoro E Della Riabilitazione
Pavia, , Italy
Spzoz Centralny Szpital Kliniczny Um W Lodzi
Lodz, , Poland
Wojewodzki Specjalistyczny Szpital W Olsztynie
Olsztyn, , Poland
Medical Company Llc
Grozny, Chechenskaya Respublika, Russia
Erciyes University Medical Faculty
Erciyes, , Turkey (Türkiye)
Kocaeli University Research and Application Hospital Department of Nephrology
Kocaeli, , Turkey (Türkiye)
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
St Heliers Hospital
Carlshalton, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Aintree University Hospital
Liverpool, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Countries
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References
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Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.
Other Identifiers
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2022-501147-32-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CTR20230546
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-3111-309
Identifier Type: -
Identifier Source: org_study_id