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A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy
Sponsor: BeOne Medicines
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.
Official title: A Phase 2/3, Multicenter, Randomized, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Zanubrutinib in Patients With Primary Membranous Nephropathy
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
178
Start Date
2023-04-17
Completion Date
2027-10
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Zanubrutinib
Zanubrutinib capsules administered orally.
Tacrolimus
Tacrolimus capsules administered orally.
Locations (48)
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
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Carolina Nephrology
Spartanburg, South Carolina, United States
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
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
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
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
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shandong Provincial Hospital
Jinan, 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
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
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
Royal Derby Hospital
Derby, United Kingdom