- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06935357
A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) (PREVAIL)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies. This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys.
The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is:
• How much does the amount of protein in the urine change from the start of the study to Week 36?
Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body.
The study will be done as follows:
- Participants will be screened to check if they can join the study.
- Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
- Neither the researchers nor the participants will know what the participants will receive.
- Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks.
- Afterwards, participants will enter a follow-up period which will last 80 weeks.
- In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: US Biogen Clinical Trial Center
- Phone Number: 866-633-4636
- Email: clinicaltrials@biogen.com
Study Contact Backup
- Name: Global Biogen Clinical Trial Center
- Email: clinicaltrials@biogen.com
Study Locations
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Buenos Aires, Argentina, C1111AAH
- Recruiting
- DOM Centro de Reumatología
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Contact:
- Phone Number: + 54 91140613734
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Principal Investigator:
- Laurencia Korman Turk
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Buenos Aires, Argentina, B1605
- Recruiting
- Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
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Contact:
- Phone Number: +54 91161732079
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Principal Investigator:
- Juan Aurelio De Francesco
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Buenos Aires, Argentina, C1425
- Not yet recruiting
- Maffei Centro Médico
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Contact:
- Phone Number: 541148019001
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Principal Investigator:
- Maria Smuclir Quevedo
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Santa Fe, Argentina, 3000
- Not yet recruiting
- Clínica de Nefrología Urología Y Enfermedades Cardiovasculares
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Contact:
- Phone Number: 543424000000
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Principal Investigator:
- Mariano Arriola
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Ciudad Autónoma de BuenosAires
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Almagro, Ciudad Autónoma de BuenosAires, Argentina, C1199ABB
- Recruiting
- Hospital Italiano de Buenos Aires
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Principal Investigator:
- Carlos Varela
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Contact:
- Phone Number: 541149590200
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Recruiting
- INECO Neurociencias Oroño
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Principal Investigator:
- Dana Miralles
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Contact:
- Phone Number: +54 341 425-8695
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, T4000CBC
- Recruiting
- CIMER-Centro Integral de Medicina Respiratoria
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Contact:
- Phone Number: +54 381 257-7481
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Principal Investigator:
- Javier Santiago Alonso
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New South Wales
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New Lambton, New South Wales, Australia, 2305
- Recruiting
- John Hunter Hospital
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New South Wales, New South Wales, Australia, 2060
- Recruiting
- Concord Repatriation General Hospital
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Westmead, New South Wales, Australia, 2145
- Recruiting
- Westmead Hospital
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Queensland
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Douglas, Queensland, Australia, 4814
- Recruiting
- Townsville Hospital
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Southport, Queensland, Australia, 4215
- Recruiting
- Gold Coast University Hospital
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Southport, Queensland, Australia, 4222
- Recruiting
- Griffith University
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Victoria
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St Albans, Victoria, Australia, 3021
- Recruiting
- Sunshine Hospital - Australia
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Brussels, Belgium, 1200
- Recruiting
- Cliniques universitaires Saint-Luc
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Principal Investigator:
- Nathalie Demoulin
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Contact:
- Phone Number: 3227647992
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Brussels Capital
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Anderlecht, Brussels Capital, Belgium, 1070
- Recruiting
- Hôpital Erasme - PPDS
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Contact:
- Phone Number: 3225556896
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Principal Investigator:
- Tess Van Meerhaeghe
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Limburg
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Genk, Limburg, Belgium, 3600
- Not yet recruiting
- ZOL Genk - campus Sint-Jan
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Contact:
- Phone Number: +3289802353
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Principal Investigator:
- Ben Sprangers
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Vlaams Brabant
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Leuven, Vlaams Brabant, Belgium, 3000
- Recruiting
- UZ Leuven - PPDS
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Principal Investigator:
- Kathleen Claes
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Contact:
- Phone Number: 3216345675
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West-Vlaanderen
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Ieper, West-Vlaanderen, Belgium, 8900
- Recruiting
- Jan Yperman
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Principal Investigator:
- Wim Terryn
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Contact:
- Phone Number: 3257357297
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Kortrijk, West-Vlaanderen, Belgium, 8500
- Recruiting
- AZ Groeninge
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Contact:
- Phone Number: 3256633366
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Principal Investigator:
- Peter Doubel
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São Paulo, Brazil, 05403-000
- Recruiting
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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Principal Investigator:
- Irene Noronha
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Contact:
- Phone Number: 551126618238
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São Paulo, Brazil, 01323-903
- Recruiting
- Hospital Alemao Oswaldo Cruz- HAOC
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Contact:
- Phone Number: 551135490449
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Principal Investigator:
- Victor Sato
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30150-320
- Recruiting
- Freire Pesquisa Clínica
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Contact:
- Phone Number: 553138790085
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Principal Investigator:
- Rosangela Do Carmo Milagres
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Belo Horizonte, Minas Gerais, Brazil, 30150221
- Recruiting
- Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS
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Contact:
- Phone Number: 553132388973
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Principal Investigator:
- Pedro Macedo de Souz
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Juiz de Fora, Minas Gerais, Brazil, 36010
- Recruiting
- Centro Mineiro de Pesquisa - CMiP
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Contact:
- Phone Number: +55 3233128920
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Principal Investigator:
- Barros de Carmo
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Rio Grande do Sul
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Caxias do Sul, Rio Grande do Sul, Brazil, 95070-560
- Recruiting
- Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde
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Contact:
- Phone Number: 555432182737
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Principal Investigator:
- Luciano Da Silva Selistre
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Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
- Recruiting
- Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
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Contact:
- Phone Number: 5199660550
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Principal Investigator:
- Cristina Karohl
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-
-
-
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Lovech, Bulgaria, 5500
- Recruiting
- Medical Center Medconsult Pleven - Lovech Branch
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Contact:
- Phone Number: 359889664169
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Principal Investigator:
- Diana Vasileva
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Montana, Bulgaria, 3400
- Recruiting
- Medical Center Hera EOOD, Montana - Hera Clinics - PPDS
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Principal Investigator:
- Irena Dimitrova
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Contact:
- Phone Number: 359892308820
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Pleven, Bulgaria, 5800
- Recruiting
- Medical Center Medconsult Pleven OOD
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Contact:
- Phone Number: 359877243610
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Principal Investigator:
- Lazar Garev
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Sofia, Bulgaria, 1606
- Recruiting
- University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD-15 Acad. Ivan Geshov Blvd
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Contact:
- Phone Number: 359887802220
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Principal Investigator:
- Atanas Kundurdjiev
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-
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- Not yet recruiting
- St Paul's Hospital
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Principal Investigator:
- Sean Barbour
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Contact:
- Phone Number: 6046822344
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Quebec
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Montreal, Quebec, Canada, H4A3J1
- Recruiting
- McGill University Health Centre (MUHC)
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Contact:
- Phone Number: 35207 5149341934
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Principal Investigator:
- Rita Suri
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Anhui
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Fuyang, Anhui, China, 236000
- Recruiting
- Fu Yang People's Hospital - South Campus
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Hefei, Anhui, China, 230022
- Recruiting
- The First Affiliated Hospital of Anhui Medical University - Jixilu Campus
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Beijing Municipality
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Beijing, Beijing Municipality, China, 102218
- Recruiting
- Beijing Tsinghua Changgung Hospital
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Beijing, Beijing Municipality, China, 100034
- Recruiting
- Peking University First Hospital - Changqiao Campus
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Fujian
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Fuzhou, Fujian, China, 350001
- Recruiting
- Fujian Medical University Union Hospital
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Xiamen, Fujian, China, 361004
- Recruiting
- Zhongshan Hospital Xiamen University
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Gansu
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Lanzhou, Gansu, China, 730000
- Recruiting
- Gansu Provincial Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Recruiting
- The First Affiliated Hospital of Guangzhou Medical University - Yanjiang Campus
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Shenzhen, Guangdong, China, 518036
- Recruiting
- Peking University Shenzhen Hospital
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Shenzhen, Guangdong, China, 510086
- Recruiting
- Shenzhen Hospital of Southern Medical University
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Zhongshan, Guangdong, China, 528401
- Recruiting
- Zhongshan Hospital of Traditional Chinese Medicine
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Guangxi
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Nanning, Guangxi, China, 530021
- Recruiting
- The First Affiliated Hospital of Guangxi Medical University
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Nanning, Guangxi, China, 530021
- Recruiting
- The People's Hospital Of Guangxi Zhuang Autonomous Region
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Guizhou
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Guiyang, Guizhou, China, 550000
- Recruiting
- The Affiliated Hospital of Guizhou Medical University
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Hebei
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Cangzhou, Hebei, China, 61011
- Recruiting
- Cangzhou Central Hospital
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Shijiazhuang, Hebei, China, 50000
- Recruiting
- The Second Hospital of Hebei Medical University - Main
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Shijiazhuang, Hebei, China, 50000
- Recruiting
- The Third Hospital of Hebei Medical University
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Heilongjiang
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Daqing, Heilongjiang, China, 163001
- Recruiting
- Daqing Oilfield General Hospital
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Henan
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Luoyang, Henan, China, 471003
- Recruiting
- The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
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Hong Kong
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Hong Kong, Hong Kong, China, 999077
- Recruiting
- Queen Mary Hospital PPDS
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Hubei
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Yichang, Hubei, China, 443003
- Recruiting
- Yichang Central People's Hospital - Wujiagang Campus
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Jiangsu
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Nanjing, Jiangsu, China, 210011
- Recruiting
- The Second Affiliated Hospital of Nanjing Medical University
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Nantong, Jiangsu, China, 226001
- Recruiting
- Affiliated Hospital of Nantong University
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Wuxi, Jiangsu, China, 214023
- Recruiting
- Wuxi Peoples Hospital
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Shandong
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Jinan, Shandong, China, 250012
- Recruiting
- Qilu Hospital of Shandong University
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Jinan, Shandong, China, 250033
- Recruiting
- The Second Hospital of Shandong University
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Yantai, Shandong, China, 264000
- Not yet recruiting
- Yantai Yuhuangding Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200080
- Recruiting
- Shanghai General Hospital - North Campus
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Shanghai, Shanghai Municipality, China, 201899
- Recruiting
- Jiading Central Hospital
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Shanghai, Shanghai Municipality, China, 200023
- Recruiting
- Zhongshan Hospital Fudan University
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Sichuan
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Chengdu, Sichuan, China, 610072
- Recruiting
- Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
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Zhejiang
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Jinhua, Zhejiang, China, 321000
- Recruiting
- Jinhua Municipal Central Hospital
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Taizhou, Zhejiang, China, 317000
- Recruiting
- Taizhou Hospital of Zhejiang Province - Main
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-
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Atlántico
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Barranquilla, Atlántico, Colombia, 80020
- Not yet recruiting
- Clinica de la Costa S.A.S. - PPDS
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Cundinamarca
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Bogotá, Cundinamarca, Colombia, 110231
- Not yet recruiting
- Hospital Universitario San Ignacio
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Zipaquirá, Cundinamarca, Colombia, 250252
- Not yet recruiting
- Healthy Medical Center S.A.S.
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760032
- Not yet recruiting
- Fundacion Valle del Lili
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-
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Rijeka, Croatia, 51000
- Recruiting
- Clinical Hospital Center Rijeka
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Contact:
- Phone Number: 38551407487
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Principal Investigator:
- Ivan Bubic
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Rijeka, Croatia, 51000
- Recruiting
- Special Hospital Medico
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Contact:
- Phone Number: 385072100700
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Principal Investigator:
- Bozidar Vujicic
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City of Zagreb
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Zagreb, City of Zagreb, Croatia, 10000
- Recruiting
- Polyclinic Bonifarm
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Contact:
- Phone Number: 385915020024
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Principal Investigator:
- Ivana Vukovic Brinar
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Zagreb, City of Zagreb, Croatia, 10000
- Recruiting
- Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29
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Contact:
- Phone Number: 385912097060
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Principal Investigator:
- Tonko Gulin
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-
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Praha, Hlavní Mesto
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Prague, Praha, Hlavní Mesto, Czechia, 140 21
- Recruiting
- Institut klinicke a experimentalni mediciny
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Contact:
- Phone Number: 420236052254
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Principal Investigator:
- Ondrej Viklicky
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-
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Dreuil-lès-Amiens, France, 80470
- Recruiting
- CHU Amiens Picardie - Site Sud
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Contact:
- Phone Number: +33 322455862
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Principal Investigator:
- Gabriel Choukroun
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Paris, France, 75020
- Recruiting
- AP-HP - Hopital Tenon
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Contact:
- Phone Number: +33 149814415
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Principal Investigator:
- Khalil El Karoui
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Paris, France, 75010
- Recruiting
- AP-HP - Hôpital Saint-Louis
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Principal Investigator:
- Evangeline Pillebout
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Contact:
- Phone Number: +33 142499631
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Bas-Rhin
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Strasbourg, Bas-Rhin, France, 67091
- Recruiting
- CHU de Strasbourg - Nouvel Hôpital Civil
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Contact:
- Phone Number: 33369551629
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Principal Investigator:
- Anna Duval
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Dobus
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Besançon, Dobus, France, 25000
- Recruiting
- CHU de Besançon
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Contact:
- Phone Number: 33381218204
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Principal Investigator:
- Melchior Chabannes
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Gironde
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Bordeaux, Gironde, France, 33076
- Recruiting
- CHU de Bordeaux - Hôpital Pellegrin
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Principal Investigator:
- Claire Rigothier
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Contact:
- Phone Number: 33557820800
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Grand Est
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Reims, Grand Est, France, 51092
- Recruiting
- CHU de Reims - Hôpital Maison Blanche
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Contact:
- Phone Number: +33326787878
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Principal Investigator:
- Vincent Verdier
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Haut-Rhin
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Mulhouse, Haut-Rhin, France, 68100
- Recruiting
- GHRMSA - Hôpital Emile Muller
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Principal Investigator:
- Francois Chantrel
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Contact:
- Phone Number: 33389646738
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Hauts-de-Seine
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Suresnes, Hauts-de-Seine, France, 92150
- Recruiting
- Hôpital Foch
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Principal Investigator:
- Arwa Jalal Eddine
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Contact:
- Phone Number: 33146253144
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Loiret
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Orléans, Loiret, France, 45067
- Recruiting
- CHRU d'Orleans- Hôpital de La Source
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Contact:
- Phone Number: +33 238651456
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Principal Investigator:
- Manon Dekeyser
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Occitanie
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Nîmes Cédex 9, Occitanie, France, 30929
- Recruiting
- CHU de Nîmes - Hopital Universitaire Caremeau
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Principal Investigator:
- Olivier Moranne
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Contact:
- Phone Number: +33779058852
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Val-de-Marne
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Créteil, Val-de-Marne, France, 94000
- Recruiting
- AP-HP - Hôpital Henri Mondor
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Principal Investigator:
- Vincent Audard
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Contact:
- Phone Number: +33 149814408
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Vendée
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La Roche-sur-Yon, Vendée, France, 85925
- Recruiting
- Centre Hospitalier Départemental de Vendée
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Contact:
- Phone Number: +33 251446572
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Principal Investigator:
- Charles Ronsin
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-
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Berlin, Germany, 10117
- Recruiting
- Charite - Universitatsmedizin Berlin
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Contact:
- Phone Number: 4930450614001
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Principal Investigator:
- Eva Schrezenmeier
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Baden-Wurttemberg
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Villingen-Schwenningen, Baden-Wurttemberg, Germany, 78052
- Recruiting
- Nephrologisches Zentrum Villingen-Schwenningen
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Principal Investigator:
- Bernd Hohenstein
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Contact:
- Phone Number: 4977219985324
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Hesse
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Frankfurt am Main, Hesse, Germany, 60596
- Recruiting
- Universitätsklinikum Frankfurt, Apotheke Haus 19
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Contact:
- Phone Number: 4969630186463
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Principal Investigator:
- Jeannine Lang
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Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, Germany, 55131
- Recruiting
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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Principal Investigator:
- Julia Weinmann-Menke
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Contact:
- Phone Number: 496131172503
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Saxony
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Dresden, Saxony, Germany, 1307
- Recruiting
- Universitätsklinikum Carl Gustav Carus an der TU Dresden
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Principal Investigator:
- Christian Hugo
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Contact:
- Phone Number: 4935145818825
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Ioannina, Greece, 34098
- Recruiting
- University General Hospital of Ioannina
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Contact:
- Phone Number: 302651007507
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Principal Investigator:
- Evangelia Ntounousi
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Thessaloniki, Greece, 54636
- Recruiting
- AHEPA University General Hospital of Thessaloniki
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Contact:
- Phone Number: 306986670500
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Principal Investigator:
- Vassilios Liakopoulos
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Achaïa
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Pátrai, Achaïa, Greece, 26500
- Recruiting
- University General Hospital of Patras
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Contact:
- Phone Number: 306949548822
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Principal Investigator:
- Evangelos Papachristou
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Attica
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Athens, Attica, Greece, 11527
- Recruiting
- Laiko General Hospital of Athens
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Contact:
- Phone Number: 302132061476
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Principal Investigator:
- Smaragdi Marinaki
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Athens, Attica, Greece, 115 27
- Recruiting
- General Hospital of Athens ''G. Gennimatas''
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Contact:
- Phone Number: 6974466366
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Principal Investigator:
- Georgios Moustakas
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Athens, Attica, Greece, 115 27
- Recruiting
- General Hospital of Athens ''Hippokratio''
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Contact:
- Phone Number: 302132088375
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Principal Investigator:
- Dimitros Petras
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Chaïdári, Attica, Greece, 12462
- Recruiting
- University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
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Contact:
- Phone Number: 6970178793
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Principal Investigator:
- Sophia Lionaki
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Irakleio
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Heraklion, Irakleio, Greece, 714 09
- Recruiting
- General Hospital of Heraklion Venizeleio
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Contact:
- Phone Number: 306974737879
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Principal Investigator:
- Dimitris Xydakis
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Heraklion, Irakleio, Greece, 715 00
- Recruiting
- PAGNI-University General Hospital of Heraklion
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Principal Investigator:
- Konstantinos Stylianou
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Contact:
- Phone Number: 306944025099
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Chandigarh, India, 160012
- Recruiting
- Postgraduate Institute of Medical Education & Research (PGIMER)
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500012
- Recruiting
- Osmania General Hospital
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Hyderabad, Andhra Pradesh, India, 500082
- Recruiting
- Nizams Institute of Medical Sciences
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Chhattisgarh
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Raipur, Chhattisgarh, India, 492099
- Recruiting
- All India Institute of Medical Sciences ( AIIMS ) - Raipur
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Gujarat
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Ahmedabad, Gujarat, India, 380081
- Recruiting
- Zydus Hospital
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Contact:
- Phone Number: +97 26881911
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Principal Investigator:
- Kamal Goplani
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Nadiād, Gujarat, India, 387001
- Recruiting
- Muljibhai Patel Society for Research in Nephro-Urology
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Karnataka
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Bangalore, Karnataka, India, 560054
- Recruiting
- M.S. Ramaiah Medical College and Hospital
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Bangalore, Karnataka, India, 560017
- Recruiting
- Manipal Hospital Bangalore
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Kerala
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Kozhikode, Kerala, India, 673008
- Recruiting
- Government Medical College, Kozhikode
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Trivandrum, Kerala, India, 695011
- Not yet recruiting
- Trivandrum Medical College Hospital
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Maharashtra
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Mumbai, Maharashtra, India, 400012
- Recruiting
- Seth G S Medical College and K E M Hospital
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Pune, Maharashtra, India, 411013
- Recruiting
- Noble Hospital
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110060
- Recruiting
- Sir Ganga Ram Hospital
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New Delhi, National Capital Territory of Delhi, India, 110017
- Recruiting
- Max Super Speciality Hospital - Saket
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226003
- Recruiting
- King George Medical University
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Lucknow, Uttar Pradesh, India, 226014
- Recruiting
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
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West Bengal
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Kolkata, West Bengal, India, 700014
- Recruiting
- Nil Ratan Sircar Medical College and Hospital
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Emilia-Romagna
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Fontevivo, Emilia-Romagna, Italy, 43010
- Recruiting
- Azienda Ospedaliero Universitaria di Parma
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Contact:
- Phone Number: 390522000000
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Principal Investigator:
- Enrico Fiaccadori
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Piacenza, Emilia-Romagna, Italy, 29121
- Recruiting
- AUSL Piacenza - Ospedale Guglielmo da Saliceto
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Contact:
- Phone Number: 390523302176
-
Principal Investigator:
- Roberto Scarpioni
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Friuli Venezia Giulia
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Trieste, Friuli Venezia Giulia, Italy, 34149
- Recruiting
- Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara
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Contact:
- Phone Number: 393489241319
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Principal Investigator:
- Vittorio Di Maso
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Liguria
-
Genoa, Liguria, Italy, 16132
- Not yet recruiting
- IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino
-
Principal Investigator:
- Pasquale Esposito
-
Contact:
- Phone Number: 390105557162
-
-
Lombardy
-
Brescia, Lombardy, Italy, 25123
- Recruiting
- ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
-
Principal Investigator:
- Federico Alberici
-
Contact:
- Phone Number: 390304000000
-
Ranica, Lombardy, Italy, 24020
- Recruiting
- Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò
-
Principal Investigator:
- Matias Trillini
-
Contact:
- Phone Number: +39 0354535309
-
Rozzano, Lombardy, Italy, 20089
- Not yet recruiting
- IRCCS Istituto Clinico Humanitas
-
Contact:
- Phone Number: 390255034583
-
Principal Investigator:
- Gabroella Moroni
-
-
Piedmont
-
Novara, Piedmont, Italy, 28100
- Withdrawn
- Azienda Ospedaliero Universitaria Maggiore della Carità
-
Turin, Piedmont, Italy, 10154
- Recruiting
- ASL Città di Torino - Ospedale San Giovanni Bosco
-
Contact:
- Phone Number: 393428507553
-
Principal Investigator:
- Fenoglio Fenoglio
-
-
-
-
Aiti
-
Toyoake-shi, Aiti, Japan, 470-1192
- Recruiting
- Fujita Health University Hospital
-
-
Aomori
-
Hirosaki-shi, Aomori, Japan, 036-8563
- Recruiting
- Hirosaki University Hospital
-
-
Chiba
-
Chiba, Chiba, Japan, 260-8712
- Recruiting
- National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
-
Urayasu-Shi, Chiba, Japan, 279-0021
- Recruiting
- Juntendo University Urayasu Hospital
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 060-8648
- Recruiting
- Hokkaido University Hospital
-
-
Hukuoka
-
Kitakyushu-shi, Hukuoka, Japan, 807-8556
- Recruiting
- Hospital of the University of Occupational and Environmental Health, Japan
-
-
Hukusima
-
Fukushima, Hukusima, Japan, 960-1247
- Recruiting
- Fukushima Medical University Hospital
-
-
Kanagawa
-
Kawasaki-shi, Kanagawa, Japan, 213-0015
- Recruiting
- Toranomon Hospital Kajigaya
-
Sagamihara-shi, Kanagawa, Japan, 252-0375
- Recruiting
- Kitasato University Hospital
-
Yokohama, Kanagawa, Japan, 236-0004
- Recruiting
- Yokohama City University Hospital
-
-
Kyôto
-
Kyoto, Kyôto, Japan, 602-8566
- Recruiting
- University Hospital, Kyoto Prefectural University of Medicine
-
-
Miyagi
-
Sendai, Miyagi, Japan, 983-8512
- Recruiting
- Tohoku Medical and Pharmaceutical University Hospital
-
-
Nara
-
Kashihara, Nara, Japan, 634-8522
- Recruiting
- Nara Medical University Hospital
-
-
Okayama-ken
-
Kurashiki, Okayama-ken, Japan, 701-0192
- Recruiting
- Kawasaki Medical School Hospital
-
-
Sizouka
-
Hamamatsu, Sizouka, Japan, 431-3192
- Recruiting
- Hamamatsu University Hospital
-
-
Tokushima
-
Tokushima, Tokushima, Japan, 770-8503
- Recruiting
- Tokushima University Hospital
-
-
Tokyo
-
Ashikaga-Shi, Tokyo, Japan, 326-0843
- Recruiting
- The Jikei University West Medical Center
-
Bunkyo-Ku, Tokyo, Japan, 113-8431
- Recruiting
- Juntendo University Hospital
-
Minato-ku, Tokyo, Japan, 105-8471
- Recruiting
- Jikei University Hospital
-
Shinagawa-ku, Tokyo, Japan, 142-86666
- Recruiting
- Showa Medical University Hospital
-
-
Ôsaka
-
Ikeda-shi, Ôsaka, Japan, 563-8510
- Recruiting
- Ikeda Municipal Hospital
-
Suita-shi, Ôsaka, Japan, 565-0871
- Recruiting
- Osaka University Hospital
-
-
-
-
Pahang
-
Kuantan, Pahang, Malaysia, 25100
- Recruiting
- Hospital Tengku Ampuan Afzan
-
Perak, Pahang, Malaysia, 30450
- Recruiting
- Hospital Raja Permaisuri Bainun
-
-
WilayahPersekutuan KualaLumpur
-
Lembah Pantai, WilayahPersekutuan KualaLumpur, Malaysia, 59100
- Recruiting
- University Malaya Medical Centre
-
-
-
-
-
Auckland, New Zealand, 1023
- Not yet recruiting
- Auckland City Hospital
-
Auckland, New Zealand, 2025
- Recruiting
- Aotearoa Clinical Trials Trust- Middlemore Hospital
-
Wellington, New Zealand, 6021
- Recruiting
- Wellington Hospital
-
-
-
-
Cebu
-
Cebu City, Cebu, Philippines, 6000
- Recruiting
- Norzel Medical and Diagnostic Clinic Foundation Corp.
-
-
-
-
-
Szczecin, Poland, 70-110
- Recruiting
- Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
-
Contact:
- Phone Number: 48506688624
-
Principal Investigator:
- Kazimierz Ciechanowski
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, Poland, 31-559
- Recruiting
- SCM Clinic - Prywatny Szpital Specjalistyczny
-
Principal Investigator:
- Dariusz Aksamit
-
Contact:
- Phone Number: +48664802950
-
Krakow, Lesser Poland Voivodeship, Poland, 30727
- Recruiting
- MCM Krakow - PRATIA - PPDS
-
Contact:
- Phone Number: 48122954139
-
Principal Investigator:
- Przemyslaw Miarka
-
-
Lódzkie
-
Lodz, Lódzkie, Poland, 92-213
- Recruiting
- SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251
-
Principal Investigator:
- Michal Nowicki
-
Contact:
- Phone Number: 48422014400
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, Poland, 80-952
- Recruiting
- Uniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7
-
Contact:
- Phone Number: 48791830095
-
Principal Investigator:
- Slawomir Lizakowski
-
-
West Pomeranian Voivodeship
-
Szczecin, West Pomeranian Voivodeship, Poland, 71-434
- Recruiting
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
-
Contact:
- Phone Number: 48609900745
-
Principal Investigator:
- Katarzyna Bobrek-Lesiakowska
-
-
-
-
-
Aveiro, Portugal, 3814
- Recruiting
- ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
-
Contact:
- Phone Number: +35 1930421587
-
Principal Investigator:
- Joana Vidinha
-
Braga, Portugal, 4710-243
- Recruiting
- Centro Clínico Académico, Braga - Hospital de Braga
-
Contact:
- Phone Number: +35 125-302-7000
-
Principal Investigator:
- Raquel Vaz
-
Coimbra, Portugal, 3004-561
- Recruiting
- ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
-
Contact:
- Phone Number: 351239400400
-
Principal Investigator:
- Emanuel Ferreira
-
Leiria, Portugal, 2410-197
- Recruiting
- ULS da Região de Leiria, EPE - Hospital de Santo André
-
Contact:
- Phone Number: 351244817000
-
Principal Investigator:
- Joana Silva
-
Setúbal, Portugal, 2910-446
- Recruiting
- ULS da Arrábida, EPE - Hospital de São Bernardo
-
Contact:
- Phone Number: +35 126 554-9048
-
Principal Investigator:
- Ana Farinha
-
-
Lisbon District
-
Carnaxide, Lisbon District, Portugal, 2790
- Recruiting
- ULS de Lisboa Ocidental, EPE - Hospital Santa Cruz
-
Contact:
- Phone Number: +35 1210433097
-
Principal Investigator:
- Eunice Cacheira
-
Vila Nova de Gaia, Lisbon District, Portugal, 4434-502
- Recruiting
- ULS de Gaia/Espinho, EPE - Unidade I
-
Contact:
- Phone Number: 351227865100
-
Principal Investigator:
- Ana Gomes
-
-
-
-
-
San Juan, Puerto Rico, 00927
- Recruiting
- FDI Clinical Research
-
Contact:
- Phone Number: (787) 763-7423
-
Principal Investigator:
- Jose Cangiano-Rivera
-
-
-
-
-
Busan, South Korea, 48108
- Recruiting
- Inje University Haeundae Paik Hospital
-
Seoul, South Korea, 03080
- Recruiting
- Seoul National University Hospital
-
Seoul, South Korea, 6351
- Recruiting
- Samsung Medical Center
-
-
Gwangyeogsi
-
Busan, Gwangyeogsi, South Korea, 49241
- Recruiting
- Pusan National University Hospital
-
-
Gyeonggido
-
Anyang-si, Gyeonggido, South Korea, 14068
- Recruiting
- Hallym University Sacred Heart Hospital
-
Seongnam-si, Gyeonggido, South Korea, 13620
- Recruiting
- Seoul National University Bundang Hospital
-
Suwon, Gyeonggido, South Korea, 16499
- Recruiting
- Ajou University Hospital
-
-
Seoul Teugbyeolsi
-
Seoul, Seoul Teugbyeolsi, South Korea, 3722
- Recruiting
- Severance Hospital Yonsei University Health System
-
Seoul, Seoul Teugbyeolsi, South Korea, 4763
- Recruiting
- Hanyang University Seoul Hospital
-
-
-
-
-
Barcelona, Spain, 8035
- Recruiting
- Hospital Universitario Vall d'Hebron - PPDS
-
Principal Investigator:
- Maria Jose Soler Romeo
-
Contact:
- Phone Number: 4661 34932746000
-
Cáceres, Spain, 10003
- Recruiting
- Hospital General San Pedro de Alcantara
-
Contact:
- Phone Number: 34605248551
-
Principal Investigator:
- Pedro Jesus Labrador Gomez
-
Girona, Spain, 17007
- Recruiting
- Hospital Universitari de Girona Dr Josep Trueta
-
Contact:
- Phone Number: 324 872987087
-
Principal Investigator:
- Nadia Martin Alemany
-
Madrid, Spain, 28041
- Recruiting
- Hospital Universitario 12 de Octubre
-
Principal Investigator:
- Eduardo Gutierrez Martinez
-
Contact:
- Phone Number: +34 913908208
-
Madrid, Spain, 28040
- Recruiting
- Hospital Universitario Fundacion Jimenez Diaz
-
Contact:
- Phone Number: 3325 34915504800
-
Principal Investigator:
- Alberto Ortiz Arduan
-
Seville, Spain, 41009
- Recruiting
- Hospital Universitario Virgen Macarena
-
Contact:
- Phone Number: 34676546066
-
Principal Investigator:
- Mercedes Lazo Salgueira
-
Zaragoza, Spain, 50009
- Recruiting
- Hospital Universitario Miguel Servet
-
Contact:
- Phone Number: 34976765624
-
Principal Investigator:
- Olga Gracia Garcia
-
-
Barcelona
-
Viladecans, Barcelona, Spain, 8840
- Recruiting
- Fundacio Puigvert
-
Contact:
- Phone Number: 34934169700
-
Principal Investigator:
- Helena Marco Rusiñol
-
-
Catalonia
-
Barcelona, Catalonia, Spain, 8003
- Recruiting
- Hospital del Mar
-
Contact:
- Phone Number: 34932483689
-
Principal Investigator:
- Eva Rodriguez Garcia
-
-
Galicia
-
A Coruña, Galicia, Spain, 15006
- Recruiting
- Hospital Universitario A Coruña
-
Contact:
- Phone Number: +34636889908
-
Principal Investigator:
- Catuxa Rodriguez Magarinos
-
-
Madrid
-
Alcorcón, Madrid, Spain, 28922
- Recruiting
- Hospital Universitario Fundacion Alcorcon
-
Contact:
- Phone Number: +34 916219400
-
Principal Investigator:
- Eva Lopez Melero
-
Getafe, Madrid, Spain, 10400
- Recruiting
- Hospital Universitario de Getafe
-
Contact:
- Phone Number: 6622026800
-
Principal Investigator:
- Judith Fatima Martins Muñoz
-
-
-
-
-
Kaohsiung City, Taiwan, 807
- Recruiting
- Kaohsiung Medical University - Chung-Ho Memorial Hospital
-
New Taipei City, Taiwan, 235041
- Recruiting
- Taipei Medical University Shuang Ho Hospital
-
-
Taiwan, Province of China
-
Dawan, Taiwan, Province of China, Taiwan, 70403
- Recruiting
- National Cheng Kung University Hospital
-
New Taipei City, Taiwan, Province of China, Taiwan, 220216
- Recruiting
- Far Eastern Memorial Hospital
-
Taichung, Taiwan, Province of China, Taiwan, 40447
- Recruiting
- China Medical University Hospital - PPDS
-
Taipei, Taiwan, Province of China, Taiwan, 104449
- Recruiting
- Mackay Memorial Hospital-Taipei branch
-
Taipei, Taiwan, Province of China, Taiwan, 116081
- Recruiting
- Taipei Municipal Wanfang Hospital
-
Taoyuan, Taiwan, Province of China, Taiwan, 33305
- Recruiting
- Chang Gung Memorial Hospital, Linkou
-
-
-
-
-
Antalya, Turkey (Türkiye), 7070
- Recruiting
- Akdeniz University Medical Faculty
-
Contact:
- Phone Number: 905309672612
-
Principal Investigator:
- Funda Sari Bahceci
-
Istanbul, Turkey (Türkiye), 34098
- Recruiting
- Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi Hastanesi
-
Principal Investigator:
- Nurhan Seyahi
-
Contact:
- Phone Number: 905379535596
-
Kayseri, Turkey (Türkiye), 38039
- Recruiting
- Erciyes Universitesi Tip Fakultesi Gevher Nesibe Hastanesi
-
Principal Investigator:
- Ismail Kocyigit
-
Contact:
- Phone Number: +905305811661
-
-
Kocaeli
-
İzmit, Kocaeli, Turkey (Türkiye), 41380
- Recruiting
- Kocaeli Üniversitesi Araştirma Ve Uygulama Hastanesi
-
Principal Investigator:
- Necmi Eren
-
Contact:
- Phone Number: +905366301577
-
-
Turkey
-
Ankara, Turkey, Turkey (Türkiye), 34899
- Recruiting
- Ankara Bilkent Sehir Hastanesi
-
Contact:
- Phone Number: 905353665205
-
Principal Investigator:
- Faith Dede
-
Istanbul, Turkey, Turkey (Türkiye), 34899
- Recruiting
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
-
Contact:
- Phone Number: 905303230775
-
Principal Investigator:
- Izzet Arikan
-
Sanliurfa, Turkey, Turkey (Türkiye), 63040
- Recruiting
- Mehmet Akif Inan Egitim ve Arastirma Hastanesi
-
Contact:
- Phone Number: 905539811595
-
Principal Investigator:
- Tuncay Sahutoglu
-
-
-
-
Lancashire
-
Preston, Lancashire, United Kingdom, PR2 9HT
- Recruiting
- Royal Preston Hospital - NWCRN- PPDS
-
Contact:
- Phone Number: 441772522031
-
Principal Investigator:
- Arvind Ponnusamy
-
-
Leicestershire
-
Leicester, Leicestershire, United Kingdom, LE5 4PW
- Recruiting
- Leicester General Hospital
-
Contact:
- Phone Number: 4401162584870
-
Principal Investigator:
- Chee Kay Cheung
-
-
South Yorkshire
-
Sheffield, South Yorkshire, United Kingdom, S5 7AU
- Recruiting
- Northern General Hospital
-
Contact:
- Phone Number: 441142715199
-
Principal Investigator:
- Salim Arif Khwaja
-
-
Staffordshire
-
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
- Recruiting
- Royal Stoke University Hospital
-
Contact:
- Phone Number: 441782672724
-
Principal Investigator:
- Diane (Julie) Wessels
-
-
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Recruiting
- Applied Research Center of Arkansas
-
Contact:
- Phone Number: 501-804-5939
-
Principal Investigator:
- John Heifner
-
-
California
-
Apple Valley, California, United States, 92307
- Recruiting
- Kidney & Hypertension Center - Apple Valley
-
Contact:
- Phone Number: 760-780-4179
-
Principal Investigator:
- Edgard Vera Tapia
-
Carlsbad, California, United States, 92009
- Recruiting
- Scripps Green Hospital
-
Contact:
- Phone Number: 617-956-2587
-
Principal Investigator:
- Kimberly Harper
-
Garden Grove, California, United States, 92844-2751
- Withdrawn
- National Institute of clinical Research Administration Office
-
Los Angeles, California, United States, 90095
- Recruiting
- UCLA Health David Geffen School of Medicine
-
Principal Investigator:
- Anjay Rastogi
-
Contact:
- Phone Number: 310-206-8478
-
Oxnard, California, United States, 93030
- Recruiting
- FOMAT Medical Research - FOMAT - PPDS
-
Contact:
- Phone Number: 805-483-1185
-
Principal Investigator:
- Koosha Mortazavi
-
San Dimas, California, United States, 91773
- Recruiting
- North America Research Institute-San Dimas
-
Principal Investigator:
- Aamir Jamal
-
Contact:
- Phone Number: 800-797-1695
-
-
Florida
-
Bradenton, Florida, United States, 34209
- Recruiting
- Nova Clinical Research, LLC
-
Contact:
- Phone Number: 941-792-6564
-
Principal Investigator:
- Hakan Toka
-
Gainesville, Florida, United States, 32610
- Not yet recruiting
- University of Florida - Gainesville - 1600 SW Archer Rd
-
Contact:
- Phone Number: 352-294-5068
-
Principal Investigator:
- Wai Lau
-
Hollywood, Florida, United States, 33024
- Recruiting
- Royal Research, Corp.
-
Contact:
- Phone Number: 954-940-0208
-
Principal Investigator:
- Elio Torres
-
Orlando, Florida, United States, 32806
- Recruiting
- Central Florida Kidney Specialists
-
Principal Investigator:
- Arvind Madan
-
Contact:
- Phone Number: 407-472-5120
-
Port Saint Lucie, Florida, United States, 34952
- Recruiting
- CDC Research Institute, LLC
-
Contact:
- Phone Number: 772-807-1636
-
Principal Investigator:
- Pablo Puello Diaz
-
-
Georgia
-
Acworth, Georgia, United States, 30101
- Withdrawn
- American Clinical Trials LLC
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115-6110
- Recruiting
- Brigham and Women's Hospital
-
Principal Investigator:
- Finnian McCausland
-
Contact:
- Phone Number: 617-732-8327
-
Boston, Massachusetts, United States, 02114-4724
- Recruiting
- The Vasculitis and Glomerulonephritis Center at Massachusetts General Hospital
-
Contact:
- Phone Number: 617-726-4132
-
Principal Investigator:
- Harish Seethapathy
-
Worcester, Massachusetts, United States, 01655
- Not yet recruiting
- UMass Memorial Medical Center
-
Contact:
- Phone Number: 413-324-8626
-
Principal Investigator:
- Xavier Vela Parada
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Hospital
-
Principal Investigator:
- Douglas Atchison
-
Contact:
- Phone Number: 313-916-0026
-
Pontiac, Michigan, United States, 48341
- Withdrawn
- Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
-
-
Mississippi
-
Brookhaven, Mississippi, United States, 39601
- Recruiting
- Anointed Nephrology and HTN - SKYCRNG - PPDS
-
Contact:
- Phone Number: 601-833-4111
-
Principal Investigator:
- James Hall
-
-
Missouri
-
City of Saint Peters, Missouri, United States, 63376
- Withdrawn
- Midwest Nephrology Associates,Inc.
-
-
New York
-
New York, New York, United States, 10029-6504
- Not yet recruiting
- Icahn School of Medicine at Mount Sinai
-
Contact:
- Phone Number: 646-286-0194
-
Principal Investigator:
- Nicholas Chun
-
The Bronx, New York, United States, 10468
- Recruiting
- James J Peters Veterans Administration Medical Center - NAVREF - PPDS
-
Principal Investigator:
- Chang Xu
-
Contact:
- Phone Number: 71858490006099
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Not yet recruiting
- Penn Renal Electrolyte and Hypertension Perelman
-
Principal Investigator:
- Gaia Coppock
-
Contact:
- Phone Number: 347-466-2774
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Recruiting
- Lifespan at Rhode Island Hospital
-
Principal Investigator:
- Jie Tang
-
Contact:
- Phone Number: 401-444-6844
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37923-3624
- Recruiting
- Knoxville Kidney Center, PLLC
-
Contact:
- Phone Number: 865 692-3462
-
Principal Investigator:
- George Newman
-
-
Texas
-
Dallas, Texas, United States, 95231
- Recruiting
- Texas Kidney Institute - Dallas
-
Contact:
- Phone Number: 214-396-4950
-
Principal Investigator:
- Sumit Kumar
-
Houston, Texas, United States, 77054
- Recruiting
- Provecta Research Network
-
Contact:
- Phone Number: 832-338-9118
-
Principal Investigator:
- Biruh Workeneh
-
Katy, Texas, United States, 77974
- Recruiting
- R & H Clinical Research
-
Contact:
- Phone Number: 713-367-2791
-
Principal Investigator:
- Syed Hussain
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
- Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF). For participants with diabetes mellitus type 2, an IgAN diagnostic biopsy within the past 24 months prior to signing the ICF.
- An eGFR ≥ 30 mL/min/1.73 m^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and < 30 mL/min/1.73 m^2 is acceptable for the cohorts 3 and 4.
- Proteinuria of ≥ 1.0 gram per day (g/day) or UPCR ≥0.8 gram per gram (g/g) as assessed by an adequate 24-hour urine collection.
- Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is); endothelin receptor antagonists (ERAs) or dual endothelin angiotensin receptor antagonist (DEARAs) approved for the treatment of IgAN; and/or mineralocorticoid receptor antagonists (MRAs) as long as the dose is stable for at least 12 weeks prior to Screening. Participants should remain on stable doses of these background medications for the duration of the study. Once the ICF is signed and thereafter, the doses cannot be changed during the study nor the drugs discontinued except if deemed related to an AE. Participants using a DEARA (e.g., sparsentan) will not be permitted to use simultaneous ACEI or ARB medication.
Key Exclusion Criteria:
- Any history of secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by the Investigator.
- History of rapidly progressive variant of IgAN, defined as eGFR loss by > 50% per 3 months and not explained by changes in renin-angiotensin system (RAS) blockade or other factors.
- IgAN-(MCD) variant.
- Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.
- Type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) > 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic microvascular or macrovascular disease (eg, diabetic retinopathy, peripheral neuropathy).
- Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, human immunodeficiency virus (HIV), primary immunodeficiencies, organ or bone marrow transplantation, with the exception of corneal transplants.
- Previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic glucocorticoid exposure (> 7.5 milligrams per day [mg/d] prednisone-equivalent for indications other than IgAN or any dose if given for the treatment of IgAN) within 4 months prior to Screening. Use of hydroxychloroquine in Mainland China is allowed if the candidate has been on this for at least 6 months prior to Screening with a stable dose for at least 12 weeks prior to Screening. If a potential participant requires systemic glucocorticoids at any dose for IgAN during Screening, this will result in a screen fail. If a potential participant requires systemic glucocorticoids > 7.5 mg/day prednisone-equivalent for indications other than IgAN during Screening, this will result in a screen fail.
- Participants currently treated with oral budesonide. Participants who have stopped this therapy ≥ 4 months prior to Screening may be eligible.
- Active clinically significant infections, known history of recurrent clinically significant infection, or Screening laboratory evidence consistent with an active infection, or non-prophylactic treatment with IV anti-infectives (antibacterials, antiviral or antifungals). Participants with a history of opportunistic infections are excluded.
- Hypogammaglobulinemia: serum Immunoglobin G (IgG) < 6.0 gram per litre (g/L), at Screening.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort 1
Participants will receive several intravenous (IV) doses of felzartamab.
|
Administered IV
Other Names:
|
|
Placebo Comparator: Cohort 2
Participants will receive several IV doses of placebo.
|
Administered IV
|
|
Experimental: Cohort 3
Participants with an estimated glomerular filtration rate (eGFR) ≥ 20 and <30 milliliter per minute per 1.73 square meter (mL/min/1.73m^2)
will receive several IV doses of felzartamab.
|
Administered IV
Other Names:
|
|
Placebo Comparator: Cohort 4
Participants with an eGFR ≥ 20 and <30 mL/min/1.73m^2
will receive several IV doses of placebo.
|
Administered IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR)
Time Frame: Baseline up to Week 36
|
Baseline up to Week 36
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Values Calculated Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation
Time Frame: Baseline up to Week 104
|
Baseline up to Week 104
|
|
|
Percentage of Participants Achieving Complete Response (CR)
Time Frame: Baseline up to Week 104
|
CR is defined as a UPCR value (based on 24-hour urine collection) of < 0.5 gram per gram (g/g), a reduction in UPCR of ≥ 50%, and a stable eGFR (decrease from baseline in eGFR of ≤ 25%).
|
Baseline up to Week 104
|
|
Percentage of Participants Requiring Rescue Therapy
Time Frame: Baseline up to Week 104
|
Baseline up to Week 104
|
|
|
Change From Baseline in eGFR Values Calculated Using the CKD-EPI Creatinine Equation
Time Frame: Baseline up to Week 52
|
Baseline up to Week 52
|
|
|
Felzartamab Serum Concentrations Over Time
Time Frame: Predose and at multiple timepoints postdose up to Week 36
|
Predose and at multiple timepoints postdose up to Week 36
|
|
|
Number of Participants with Anti-Drug Antibodies (ADAs) Against Felzartamab
Time Frame: Baseline up to Week 104
|
Baseline up to Week 104
|
|
|
Percentage of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)
Time Frame: Baseline up to Week 104
|
Baseline up to Week 104
|
|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Abnormalities
Time Frame: Baseline up to Week 104
|
Baseline up to Week 104
|
|
|
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time Frame: Baseline up to Week 104
|
Baseline up to Week 104
|
|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Abnormalities
Time Frame: Baseline up to Week 104
|
Baseline up to Week 104
|
|
|
Number of Participants With Clinically Significant Change From Baseline in Physical Examinations Abnormalities
Time Frame: Baseline up to Week 104
|
Baseline up to Week 104
|
|
|
Percentage of Participants who Progressed to Kidney Malfunction
Time Frame: Baseline up to Week 104
|
The percentage of participants progressing to kidney malfunction will be reported based on one of the following, 1. ≥ 40% Reduction in eGFR Sustained for ≥ 30 Days, 2. eGFR <15 mL/min/1.73
m^2 for ≥ 30 Days, 3. Undergoing Dialysis for ≥ 30 Days, 4. Undergoing Kidney Transplantation, 5. Died From Kidney Failure
|
Baseline up to Week 104
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Medical Director, Biogen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Autoimmune Diseases
- Immune System Diseases
- Glomerulonephritis
- Nephritis
- Glomerulonephritis, IGA
- Substandard Drugs
- Pharmaceutical Preparations
- felzartamab
Other Study ID Numbers
- 299IG301
- 2024-519345-30-00 (Other Identifier: EU CT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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