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A Study to Evaluate the Safety and Efficacy of Zanubrutinib in Participants With Primary Membranous Nephropathy

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研究单位: [1]BeiGene [2]Amicis Research Center,Northridge,California,United States,91324 [3]Stanford University,Palo Alto,California,United States,94304 [4]Northwestern University Feinberg School of Medicine,Chicago,Illinois,United States,60611 [5]Northshore University Healthsystem,Evanston,Illinois,United States,60201 [6]Intermed Consultants,Edina,Minnesota,United States,55435 [7]Kidney Specialist of Southern Nevada (Ksosn),Las Vegas,Nevada,United States,89106 [8]Donald and Barbara Zucker School of Medicine At Northwell Health,Great Neck,New York,United States,11021 [9]University of Cincinnati Cancer Center,Cincinnati,Ohio,United States,45267 [10]Carolina Nephrology,Spartanburg,South Carolina,United States,29306 [11]Prolato Clinical Research Center,Houston,Texas,United States,77054 [12]Medical College of Wisconsin,Milwaukee,Wisconsin,United States,53226 [13]Investigacion Clinica Aplicada,Buenos Aires,Argentina,1865 [14]Centro de Investigaciones Madicas Mar Del Plata,Mar del Plata,Argentina,7600 [15]Cer San Juan Centro Polivalente de Asistencia E Investigacian Clanica,San Juan,Argentina,5400 [16]Centro de Investigaciones Medicas Tucuman,San Miguel de Tucuman,Argentina,4000 [17]Clipem Clinica E Pesquisa Em Endocrinologia de Maringa,Maringa,Brazil,87000-000 [18]Hospital Das Clnicas Da Universidade Federal de Pernambuco,Recife,Brazil,50000-000 [19]Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp,Ribeirao Preto,Brazil,14051140 [20]Hospital Alemao Oswaldo Cruz,Sao Paulo,Brazil,04829-310 [21]Chum Centre de Recherche,Montreal,Canada,H2X 3E4 [22]Cisss de La Monteregie Centre,Quebec,Canada,G1S 1L7 [23]Ott Healthcare, Inc,Scarborough,Canada,M1H 3G4 [24]University of British Columbia,Vancouver,Canada,V6K 2P1 [25]Beijing An Zhen Hospital of the Capital University of Medical Sciences,Beijing,Beijing,China,100029 [26]Peking University First Hospital,Beijing,Beijing,China,100034 [27]Peking University Peoples Hospital,Beijing,Beijing,China,100044 [28]The First Affiliated Hospital of Fujian Medical University,Fuzhou,Fujian,China,350005 [29]Guangdong Provincial Peoples Hospital,Guangzhou,Guangdong,China,510080 [30]The First Affiliated Hospital, Sun Yat Sen University,Guangzhou,Guangdong,China,510080 [31]Peking University Shenzhen Hospital,Shenzhen,Guangdong,China,518036 [32]The First Affiliated Hospital of Guangxi Medical University,Nanning,Guangxi,China,530021 [33]Guizhou Provincial Peoples Hospital,Guiyang,Guizhou,China,550002 [34]The First Hospital of Hebei Medical University,Shijiazhuang,Hebei,China,50000 [35]Nanyang Central Hospital,Nanyang,Henan,China,473000 [36]The First Affiliated Hospital of Xinxiang Medical University,Xinxiang,Henan,China,453100 [37]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China,450052 [38]Renmin Hospital of Wuhan University,Wuhan,Hubei,China,430060 [39]Zhongda Hospital Southeast University,Nanjing,Jiangsu,China,210009 [40]Jiangsu Province Hospital,Nanjing,Jiangsu,China,210029 [41]Wuxi Peoples Hospital,Wuxi,Jiangsu,China,214023 [42]Affiliated Hospital of Jiangsu University,Zhenjiang,Jiangsu,China,212001 [43]First Affiliated Hospital of Dalian Medical University,Dalian,Liaoning,China,116011 [44]Shengjing Hospital of China Medical University,Shenyang,Liaoning,China,110004 [45]General Hospital of Ningxia Medical University,Yinchuan,Ningxia,China,750004 [46]Shandong Provincial Hospital,Jinan,Shandong,China,250021 [47]The Affiliated Hospital of Qingdao University Branch South,Qingdao,Shandong,China,266000 [48]Rui Jin Hospital Shanghai Jiao Tong University School of Medicine,Shanghai,Shanghai,China,200025 [49]Shanghai General Hospital,Shanghai,Shanghai,China,200080 [50]Shanxi Provincial Peoples Hospital,Taiyuan,Shanxi,China,030012 [51]Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital,Chengdu,Sichuan,China,610071 [52]Tianjin Union Medical Center (Nankai University Affiliated Hospital),Tianjin,Tianjin,China,300121 [53]The First Affiliated Hospital of Xinjiang Medical University,Urumqi,Xinjiang,China,830054 [54]The First Peoples Hospital of Yunnan Province,Kunming,Yunnan,China,650034 [55]The First Affiliated Hospital, Zhejiang University School of Medicine,Hangzhou,Zhejiang,China,310003 [56]Zhejiang Provincial Peoples Hospital,Hangzhou,Zhejiang,China,310014 [57]Fakultni Nemocnice Olomouc,Olomouc,Czechia,77900 [58]Vseobecna Fakultni Nemocnice V Praze,Praha,Czechia,10000 [59]Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi,Bologna,Italy,40138 [60]Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia,Brescia,Italy,25123 [61]Istscientifico Di Pavia, Fondazione Smaugeri, Irccs, Clinica Del Lavoro E Della Riabilitazione,Pavia,Italy,27100 [62]Centenario Hospital Miguel Hidalgo,Aguascalientes,Mexico,2008 [63]Hospital Angeles Chihuahua,Chihuahua,Mexico,31104 [64]Morales Vargas Centro de Investigacion Sc,Leon,Mexico,36090 [65]IECSI,Monterrey,Mexico,64310 [66]Spzoz Centralny Szpital Kliniczny Um W Lodzi,Lodz,Poland,92-213 [67]Wojewodzki Specjalistyczny Szpital W Olsztynie,Olsztyn,Poland,10-561 [68]Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu,Wroclaw,Poland,50-556 [69]Hospital Universitario Vall Dhebron,Barcelona,Spain,08035 [70]Fundacion Puigvert,Barcelona,Spain,8025 [71]Hospital Clinico San Carlos,Madrid,Spain,28040 [72]Hospital Universitario Virgen Del Rocio,Sevilla,Spain,41013 [73]Erciyes University Medical Faculty,Erciyes,Turkey,38030 [74]Kocaeli University Research and Application Hospital Department of Nephrology,Kocaeli,Turkey,41380 [75]Kahramanmaras Sutcu Imam University,Onikiubat,Turkey,46050 [76]St Heliers Hospital,Sutton,Carlshalton,United Kingdom,SM5 1AA [77]Aberdeen Royal Infirmary,Aberdeen,United Kingdom,AB25 2ZN [78]Royal Derby Hospital,Derby,United Kingdom,DE22 3NE [79]Aintree University Hospital,Liverpool,United Kingdom,L9 7AL [80]Hammersmith Hospital,London,United Kingdom,W12 0HS [81]Manchester Royal Infirmary,Manchester,United Kingdom,M13 9WL

研究目的:
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 who are on optimal supportive care.

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