A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression (IMAGINATION)
May 8, 2026 updated by: Hoffmann-La Roche
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sefaxersen, an Antisense Inhibitor of Complement Factor B, in Patients With Primary IgA Nephropathy at High Risk of Progression
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of sefaxersen (RO7434656), a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
428
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: WA43966 https://forpatients.roche.com/
- Phone Number: 888-662-6728 (U.S. Only)
- Email: global-roche-genentech-trials@gene.com
Study Locations
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Ciudad Autonoma Buenos Aires, Argentina, C1426ABP
- Recruiting
- Consultorios Médicos Dr. Doreski
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Ciudad Autonoma Buenos Aires, Argentina, C1425AGC
- Recruiting
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
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Córdoba, Argentina, X5000JHQ
- Recruiting
- Sanatorio Allende
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Córdoba, Argentina, 5000
- Recruiting
- Sanatorio Mayo Privado
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Rosario, Argentina, S2013DTC
- Recruiting
- Instituto Médico de la Fundación Estudios Clínicos
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New South Wales
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Kingswood, New South Wales, Australia, 02747
- Recruiting
- Nepean Hospital
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Kogarah, New South Wales, Australia, 2217
- Recruiting
- St George Hospital
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Liverpool, New South Wales, Australia, 2170
- Recruiting
- Liverpool Hospital
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Queensland
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Woolloongabba, Queensland, Australia, 4102
- Recruiting
- Princess Alexandra Hospital
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South Australia
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Adelaide, South Australia, Australia, SA5000
- Recruiting
- Royal Adelaide Hospital
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Victoria
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Parkville, Victoria, Australia, 3050
- Recruiting
- Royal Melbourne Hospital
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St Albans, Victoria, Australia, 3021
- Recruiting
- Sunshine Hospital
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Rio de Janeiro, Brazil, 22281
- Recruiting
- Instituto D?Or Pesquisa e Ensino - Hospital Gloria D?Or
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30150-221
- Recruiting
- Santa Casa de Misericordia de Belo Horizonte - PPDS
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Belo Horizonte, Minas Gerais, Brazil, 30150
- Recruiting
- Freire Pesquisa Clínica
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Rio Grande do Sul
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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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Santa Catarina
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Joinville, Santa Catarina, Brazil, 89227-680
- Recruiting
- Centro de Pesquisa Clinica da Fundação Pró Rim
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São Paulo
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São Paulo, São Paulo, Brazil, 01246
- Recruiting
- Faculdade de Medicina da Universidade de Sao Paulo
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São Paulo, São Paulo, Brazil, 04038-002
- Recruiting
- Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos
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Québec, Canada, G1R 2J6
- Recruiting
- Centre Hospitalier Universitaire de Québec
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Recruiting
- Vancouver General Hospital
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Nova Scotia
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Sydney, Nova Scotia, Canada, B1P 1P3
- Recruiting
- Cape Breton Regional Hospital
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Ontario
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London, Ontario, Canada, N6A 5W9
- Recruiting
- London Health Sciences Centre · Victoria Hospital
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Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada, H3G 1A4
- Recruiting
- Montreal General Hospital
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Beijing, China, 100034
- Recruiting
- Peking University First Hospital
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Beijing, China, 100044
- Recruiting
- Peking University People's Hospital
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Changzhou, China, 213003
- Recruiting
- Changzhou First People's Hospital
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Chengdu, China, 610041
- Recruiting
- West China Hospital, Sichuan University
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Chengdu, China, 610072
- Recruiting
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Guangzhou, China, 510080
- Recruiting
- Guangdong Provincial People's Hospital
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Hangzhou, China, 310016
- Recruiting
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
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Hangzhou, China, 310014
- Recruiting
- Zhejiang Provincial People?s Hospital
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Nanchang, China, 330008
- Recruiting
- The Second Affiliated Hospital of Nanchang University
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Nanchang, China, 330000
- Recruiting
- The First Affiliated Hospital of Nanchang University
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Nanjing, China, 210003
- Recruiting
- The Second Affiliated Hospital of Nanjing Medical University
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Ningbo, China, 315000
- Recruiting
- Ningbo NO.2 Hospital
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Shanghai, China
- Recruiting
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
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Shanghai, China, 200025
- Recruiting
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
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Shenzhen, China, 518020
- Recruiting
- Shenzhen People's Hospital
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Shenzhen, China, 518053
- Recruiting
- The University of Hong Kong - Shenzhen Hospital
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Suzhou, China, 215004
- Recruiting
- The Second Affiliated Hospital of Soochow University
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Wuhan, China, 430060
- Recruiting
- Renmin Hospital of Wuhan University
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Xi'an, China, 710061
- Recruiting
- The First Affiliated Hospital of Xian Jiao Tong University
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Yinchuan, China, 750004
- Recruiting
- General Hospital of Ningxia Medical University
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Zhenjiang, China, 212001
- Recruiting
- Affiliated Hospital of Jiangsu University
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Beijing Municipality
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Beijing, Beijing Municipality, China, 000000
- Recruiting
- Beijing Friendship Hospital, Capital Medical University - PPDS
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Hebei
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Cangzhou Shi, Hebei, China, 060001
- Recruiting
- Cangzhou Central Hospital
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Shijiazhuang, Hebei, China, 050031
- Recruiting
- The First Hospital of Hebei Medical University
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Jiangsu
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Wuxi, Jiangsu, China, 214023
- Recruiting
- Wuxi People's Hospital
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Hradec Králové, Czechia, 500 05
- Recruiting
- Fakultni nemocnice Hradec Kralove
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Prague, Czechia, 12808
- Recruiting
- Vseobecna fakultni nemocnice v Praze
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Annonay, France, 07103
- Recruiting
- Centre Hospitalier
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Boulogne-sur-Mer, France, 62200
- Recruiting
- CHU Boulogne sur Mer
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Créteil, France, 94000
- Recruiting
- Hôpital Henri Mondor
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Paris, France, 75020
- Recruiting
- Hopital Tenon
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Paris, France, 75877
- Recruiting
- Hopital Bichat - Claude Bernard AP-HP
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Toulouse, France, 31059
- Recruiting
- Hopital de Rangueil
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Aachen, Germany, 52074
- Recruiting
- Universitätsklinikum der RWTH Aachen
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Berlin, Germany, 10117
- Recruiting
- Charite Universitaetsmedizin Berlin - Campus Charite Mitte
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Berlin, Germany, 12101
- Recruiting
- St. Joseph-Krankenhaus
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Cologne, Germany, 51109
- Recruiting
- Klinikum Köln-Merheim
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Hanover, Germany, 30625
- Recruiting
- Medizinische Hochschule Hannover
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Mainz, Germany, 55101
- Recruiting
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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Stuttgart, Germany, 70376
- Recruiting
- Robert-Bosch-Krankenhaus
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Villingen-Schwenningen, Germany, 78052
- Recruiting
- Nephrologisches Zentrum Villingen-Schwenningen
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Saxony
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Leipzig, Saxony, Germany, 04103
- Recruiting
- Universitatsklinikum Leipzig
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Heraklion, Greece, 71110
- Recruiting
- University General Hospital of Heraklion
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Heraklion, Greece, 714 09
- Recruiting
- Venizeleio General Hospital of Heraklion
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Pátrai, Greece, 265 04
- Recruiting
- University General Hospital of Patras
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Thessaloniki, Greece, 546 42
- Withdrawn
- Ippokratio General Hospital of Thessaloniki
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Hong Kong, Hong Kong, 999077
- Recruiting
- Queen Mary Hospital
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Apulia
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Bari, Apulia, Italy, 70124
- Recruiting
- Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
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Campania
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Naples, Campania, Italy, 80131
- Recruiting
- Azienda Ospedaliera Universitaria Federico II
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italy, 40138
- Recruiting
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
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Lazio
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Rome, Lazio, Italy, 00168
- Recruiting
- Fondazione Policlinico Universitario A Gemelli
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Liguria
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Genoa, Liguria, Italy, 16132
- Recruiting
- Ospedale Policlinico San Martino
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Lombardy
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Pavia, Lombardy, Italy, 27100
- Recruiting
- IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit
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Piedmont
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Turin, Piedmont, Italy, 10154
- Recruiting
- Ospedale San Giovanni Bosco
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Aichi, Japan, 470-1192
- Recruiting
- Fujita Health University Hospital
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Aomori, Japan, 036-8563
- Recruiting
- Hirosaki University Hospital
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Chiba, Japan, 279-0021
- Recruiting
- Juntendo University Urayasu Hospital
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Chūō, Japan, 409-3821
- Recruiting
- University of Yamanashi Hospital
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Ehime, Japan, 790-8524
- Recruiting
- Matsuyama Red Cross Hospital
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Fukuoka, Japan, 815-8555
- Recruiting
- Japanese Red Cross Fukuoka Hospital
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Hiroshima, Japan, 734-8551
- Recruiting
- Hiroshima University Hospital
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Hokkaido, Japan, 060-8648
- Recruiting
- Hokkaido University Hospital
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Inashiki-Gun, Japan, 300-0395
- Recruiting
- Tokyo Medical University Ibaraki Medical Center
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Ishikawa, Japan, 920-0293
- Recruiting
- Kanazawa Medical University Hospital
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Kashihara, Japan, 634-8522
- Recruiting
- Nara Medical University Hospital
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Kumamoto, Japan, 860-8556
- Recruiting
- Kumamoto University Hospital
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Miyagi, Japan, 980-8574
- Recruiting
- Tohoku University Hospital
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Nakagyo-ku, Japan, 604-8845
- Recruiting
- Kyoto City Hospital
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Nara, Japan, 630-8054
- Recruiting
- Nara Prefecture General Medical Center
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Nishinomiya, Japan, 662-0918
- Recruiting
- Hyogo Prefectural Nishinomiya Hospital
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Numakunai, Japan, 028-3695
- Recruiting
- Iwate Medical University Hospital
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Okayama, Japan, 701-1192
- Recruiting
- National Hospital Organization Okayama Medical Center
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Okayama-Shi Kita-Ku, Japan, 700-0914
- Recruiting
- Okayama University Hospital
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Okinawa, Japan, 903-0125
- Recruiting
- University of the Ryukyus Hospital
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Saitama, Japan, 350-0451
- Recruiting
- Saitama Medical University Hospital
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Suita, Japan, 565-0871
- Recruiting
- Osaka University Hospital
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Tochigi, Japan, 329-0498
- Recruiting
- Jichi Medical University Hospital
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Tokushima, Japan, 770-8503
- Recruiting
- Tokushima University Hospital
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Tokyo, Japan, 113-8431
- Recruiting
- Juntendo University Hospital
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Tokyo, Japan, 105-8471
- Recruiting
- The Jikei University Hospital
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Tokyo, Japan, 162-8666
- Recruiting
- Tokyo Women's Medical University Hospital
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Tokyo, Japan, 177-8521
- Recruiting
- Juntendo University Nerima Hospital, department of renal and hypertension
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Tsukuba, Japan, 305-8576
- Recruiting
- University of Tsukuba Hospital
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Ube, Japan, 755-8505
- Recruiting
- Yamaguchi University Hospital
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Ampang, Malaysia, 68000
- Recruiting
- Hospital Ampang
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Miri, Malaysia, 98000
- Recruiting
- Miri Hospital
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FED. Territory of Kuala Lumpur
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Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia, 50586
- Recruiting
- Hospital Kuala Lumpur
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Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia, 59100
- Recruiting
- University Malaya Medical Centre
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Pahang
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Kuantan, Pahang, Malaysia, 25100
- Recruiting
- Hospital Tengku Ampuan Afzan
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Seri Manjong, Pahang, Malaysia, 32040
- Recruiting
- Hospital Seri Manjung
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Perak
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Taiping, Perak, Malaysia, 34000
- Recruiting
- Taiping Hospital
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Sarawak
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Sibu, Sarawak, Malaysia, 96000
- Recruiting
- Hospital Sibu
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Aguascalientes
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Fracc Lomas Del Campestre, Aguascalientes, Mexico, 20129
- Recruiting
- Clinica San Cosme
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Mexico CITY (federal District)
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Barrio Belisario Domínguez Secc XVI, Mexico CITY (federal District), Mexico, 14080
- Recruiting
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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Michoacán
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Morelia, Michoacán, Mexico, 58260
- Recruiting
- Centro de Investigacion Clinica Chapultepec S. A. de C. V.
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Morelos
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Cuernavaca, Morelos, Mexico, 62448
- Recruiting
- Instituto Mexicano de Trasplantes
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64000
- Recruiting
- Christus Latam Hub Center Of Excellence & Innovation
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Krakow, Poland, 31-559
- Recruiting
- SCM Clinic - Prywatny Szpital Specjalistyczny
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Lodz, Poland, 92-213
- Recruiting
- SPZOZ Centralny Szpital Klin
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Opole, Poland, 45401
- Recruiting
- Uniwersytecki Szpital Kliniczny w Opolu
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Późna, Poland, 60-355
- Recruiting
- Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu
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Warsaw, Poland, 02-006
- Recruiting
- Szpital Kliniczny Dzieciatka Jezus
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Wroc?aw, Poland, 50-556
- Recruiting
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Poland, 53-114
- Recruiting
- 4. Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
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Singapore, Singapore, 169608
- Recruiting
- Singapore General Hospital
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Singapore, Singapore, 308433
- Recruiting
- Tan Tock Seng Hospital
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Singapore, Singapore, 119074
- Recruiting
- National University Hospital
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Singapore, Singapore, 529889
- Recruiting
- Changi General Hospital
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Anyang-si, South Korea, 14068
- Recruiting
- Hallym University Sacred Heart Hospital
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Bucheon-si, South Korea, 420-767
- Recruiting
- Soon Chun Hyang University Hospital Bucheon
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Cheongju-si, South Korea, 28644
- Recruiting
- Chungbuk National University Hospital
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Gyeonggi-do, South Korea, 443-380
- Recruiting
- Ajou University Hospital
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Seongnam-si, South Korea, 13620
- Recruiting
- Seoul National University Bundang Hospital
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Seongnam-si, South Korea, 13496
- Recruiting
- CHA Bundang Medical Center, CHA University
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Seoul, South Korea, 03080
- Recruiting
- Seoul National University Hospital
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Seoul, South Korea, 05030
- Recruiting
- Konkuk University Medical Center
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Seoul, South Korea, 06351
- Recruiting
- Samsung Medical Center
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Seoul, South Korea, 05278
- Recruiting
- Gangdong Kyung Hee University Hospital
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Seoul, South Korea, 156-707
- Recruiting
- SMG-SNU Boramae Medical Center
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Barcelona, Spain, 08035
- Recruiting
- Hospital Universitario Vall d'Hebron - PPDS
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Córdoba, Spain, 14004
- Recruiting
- C.H. Regional Reina Sofia - PPDS
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Lugo, Spain, 27004
- Recruiting
- Hospital Ribera Polusa
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Madrid, Spain, 28041
- Recruiting
- Hospital Universitario 12 de Octubre
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Madrid, Spain, 28046
- Recruiting
- Hospital Universitario La Paz - PPDS
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Seville, Spain, 41013
- Recruiting
- Hospital Universitario Virgen del Rocio - PPDS
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Lerida
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Lleida, Lerida, Spain, 25198
- Recruiting
- Hospital Universitari Arnau de Vilanova
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-
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-
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Changhua, Taiwan, 500
- Recruiting
- Changhua Christian Hospital
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Kaohsiung City, Taiwan, 83301
- Recruiting
- Chang Gung Medical Foundation
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Taichung, Taiwan, 40447
- Recruiting
- China Medical University Hospital
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Taipei, Taiwan, 220
- Recruiting
- Far Eastern Memorial Hospital
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Taoyuan City, Taiwan, 333
- Recruiting
- Chang Gung Memorial Hospital, Linkou
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Xitun Dist., Taiwan, 40705
- Recruiting
- Taichung Veterans General Hospital
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Zhongshan Dist., Taiwan, 10449
- Recruiting
- Mackay Memorial Hospital-Taipei branch
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Cambridge, United Kingdom, CB2 0QQ
- Recruiting
- Addenbrookes Hospital
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Leicester, United Kingdom, LE5 4PW
- Recruiting
- Leicester General Hospital
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London, United Kingdom, SE5 9RS
- Recruiting
- Kings College Hospital
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London, United Kingdom, SE1 9RT
- Recruiting
- Guys and St Thomas Hospital
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Oxford, United Kingdom, OX3 7LE
- Recruiting
- Churchill Hospital
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Salford, United Kingdom, M6 8HD
- Recruiting
- Salford Royal Hospital
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Alabama
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Alabaster, Alabama, United States, 35007-8823
- Recruiting
- Alabama Kidney Research - ERN - PPDS
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Birmingham, Alabama, United States, 35233
- Recruiting
- UAB Nephrology Research Clinic
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Arizona
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Surprise, Arizona, United States, 85374-8644
- Withdrawn
- Sunrise Medical Management LLC
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Tucson, Arizona, United States, 85710
- Withdrawn
- Tucson Neuroscience Research - M3 WR
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California
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Glendale, California, United States, 91206-4032
- Recruiting
- Kidney Disease Medical Group Inc-1505 Wilson Ter
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La Palma, California, United States, 90623
- Withdrawn
- Southern California Medical Research Center
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Los Angeles, California, United States, 90022
- Recruiting
- Academic Medical Research Institute - Los Angeles
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Los Angeles, California, United States, 90025-4837
- Recruiting
- University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica
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Montebello, California, United States, 90640-2217
- Recruiting
- Los Angeles County Nephrology
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San Dimas, California, United States, 91773
- Recruiting
- North America Research Institute-San Dimas
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San Jose, California, United States, 95110
- Recruiting
- Kaiser Permanente Skyport Medical Offices
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Florida
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Doral, Florida, United States, 33122
- Recruiting
- BioResearch Partner ? Jackson West
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Hialeah, Florida, United States, 33010
- Withdrawn
- Hope Clinic & Research Center
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Miami, Florida, United States, 33126
- Withdrawn
- LCC Medical Research - Miami - ClinEdge - PPDS
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Orlando, Florida, United States, 32806
- Recruiting
- Central Florida Kidney Specialists
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West Miami, Florida, United States, 33144
- Recruiting
- L&C Professional Medical Research Institute
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Georgia
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Acworth, Georgia, United States, 30101
- Recruiting
- Cowry Medical Group LLC
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Idaho
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Chubbuck, Idaho, United States, 83202
- Recruiting
- Care Institute Idaho Kidney Institute
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Idaho Falls, Idaho, United States, 83402
- Recruiting
- Care Institute Idaho Kidney Institute
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Illinois
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Hinsdale, Illinois, United States, 60521
- Recruiting
- Nephrology Associates of Northern Illinois
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Iowa
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Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Recruiting
- Massachussets General Hospital
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Mississippi
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Jackson, Mississippi, United States, 39216
- Recruiting
- University of Mississippi Medical Center
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Nevada
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Reno, Nevada, United States, 89511
- Recruiting
- Sierra Nevada Nephrology Consultants
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New York
-
Mineola, New York, United States, 11501
- Recruiting
- NYU Langone Nephrology Associates - Mineola
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North Carolina
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Raleigh, North Carolina, United States, 27609
- Recruiting
- North Carolina Nephrology, PA
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Ohio
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Cleveland, Ohio, United States, 44195-0001
- Recruiting
- Cleveland Clinic-9500 Euclid Ave
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Columbus, Ohio, United States, 43203
- Recruiting
- Ohio State University Wexner Medical Center - Outpatient Care East
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Oregon
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Roseburg, Oregon, United States, 97471
- Withdrawn
- Kidney and Hypertension Center
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Texas
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Austin, Texas, United States, 78751-3014
- Recruiting
- Austin Diagnostic Clinic - Frenova F1
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Dallas, Texas, United States, 75231
- Recruiting
- Texas Kidney Institute - Dallas
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Dallas, Texas, United States, 75224
- Withdrawn
- Global Medical Research - M3 WR
-
Houston, Texas, United States, 77054
- Recruiting
- Prolato Clinical Research Center
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Houston, Texas, United States, 077099
- Recruiting
- Pioneer Research Solutions
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Katy, Texas, United States, 77449
- Recruiting
- R & H Clinical Research
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McKinney, Texas, United States, 75071
- Recruiting
- Revival Research Institute - McKinney
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Utah
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Salt Lake City, Utah, United States, 84115
- Recruiting
- Utah Kidney Research Institute
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Virginia
-
Fairfax, Virginia, United States, 22033
- Recruiting
- Nephrology Associates of Northern Virginia Inc
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University
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Wisconsin
-
Wauwatosa, Wisconsin, United States, 53226
- Withdrawn
- Milwaukee Nephrologists, Sc
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Primary IgAN, as evidenced by a kidney biopsy performed within 10 years prior to or during screening, without known secondary cause
- Treatment with maximum tolerated doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) for at least 90 days immediately prior to screening, and without an intent to modify the dose during the study, except for interruptions due to illness (not greater than 7 consecutive days), unless the potential participant is intolerant to these medications
- Urine Protein-to-Creatinine Ratio (UPCR) ≥ 1 gram per gram (g/g) or urine protein excretion ≥ 1 gram per day (g/day) (with UPCR ≥ 0.8 g/g), all measured from a 24-hour urine collection during screening
- eGFR ≥ 20 mL/min/1.73 m^2, as calculated by the 2021 CKD-EPI creatinine equation (Inker et al. 2021a)
- Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to national vaccination recommendations
- Female participants of childbearing potential must use adequate contraception
Exclusion Criteria:
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final dose of sefaxersen
- Histopathologic or other evidence of another autoimmune glomerular disease
- Presence of ≥ 50% crescents on kidney biopsy, sustained doubling of serum creatinine within 3 months prior to screening, or rapidly progressive glomerulonephritis in the opinion of the investigator
- History of kidney transplantation
- Glycated Hemoglobin (HbA1c) ≥ 6.5% or a clinical diagnosis of diabetes mellitus of any type
- Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg from the average of two measurements performed at least 1 minute apart during screening
- Initiation of sodium-glucose cotransporter-2 (SGLT2) inhibitors within 16 weeks prior to screening or during screening
- Initiation of endothelin receptor antagonists within 90 days prior to screening or during screening
- Initiation of mineralocorticoid receptor antagonists or non-dihydropyridine calcium channel blockers within 90 days prior to screening or during screening
- Use of herbal therapies within 90 days prior to or during screening
- Treatment with investigational therapy within 28 days prior to screening or 5.5 drug-elimination half-lives of that investigational product prior to screening
- Treatment with an investigational therapy planned during the treatment period
- Previous treatment with sefaxersen
- Treatment with oral or intravenous (IV) corticosteroids with a dose equivalent to ≥ 7.5 milligrams per day (mg/day) of prednisone for 7 days or equivalent to ≥ 5 mg/day of prednisone for 14 days within 90 days prior to screening
- Treatment with corticosteroids with systemic effects during screening
- Treatment with a systemic calcineurin inhibitor within 2 months prior to screening or during screening
- Treatment with anti-CD20 therapy within 9 months of screening or during screening
- Treatment with other systemic immunosuppressive agents within 6 months of randomization including, but not limited to, complement inhibitors, alkylating agents (e.g., cyclophosphamide or chlorambucil), azathioprine, or mycophenolate
- Planned major procedure or major surgery during screening or the study
- Substance abuse within 12 months prior to screening or during screening
- Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study
- History of malignancy within < 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
- Usage of Glucagon-like Peptide-1 (GLP-1)-based therapy (i.e., GLP-1 mono-agonists, GLP-1/GIP dual agonists, etc.) within 90 days prior to screening or during screening, or intent to initiate during the study period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Sefaxersen (RO7434656)
Participants will receive subcutaneous (SC) doses of sefaxersen (RO7434656) on Days 1, 15, and 29 followed by once every 4 weeks (Q4W) until Week 105.
Participants may be eligible to switch to open-label treatment after Week 105 at the investigator's discretion until up to 1 year after the common-close timepoint, the date when the last participant completes the Week 105 assessment, withdraws, or is discontinued from the study.
|
Sefaxersen (RO7434656) will be administered as SC injection per schedule as specified.
Other Names:
|
|
Placebo Comparator: Placebo
Participants will receive SC doses of sefaxersen (RO7434656) matching placebo on Days 1, 15, and 29 followed by once Q4W until Week 105.
Participants may be eligible to switch to open-label treatment after Week 105 at the investigator's discretion until up to 1 year after the common-close timepoint, the date when the last participant completes the Week 105 assessment, withdraws, or is discontinued from the study.
|
Matching placebo will be administered as SC injection per schedule as specified.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37
Time Frame: Baseline, Week 37
|
UPCR will be assessed in urine sampled over 24 hours.
|
Baseline, Week 37
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR) Slope at Week 105 from Baseline
Time Frame: Baseline, Week 105
|
eGFR will be calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation.
|
Baseline, Week 105
|
|
Change From Baseline in Fatigue at Week 105
Time Frame: Baseline, Week 105
|
Fatigue will be assessed with the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F).
The FACIT-F Scale is a 13-item scale used to measure self-reported fatigue.
Items are assessed on a 5-point Likert scale, with responses ranging from 0 for "not at all" to 4 for "very much".
The total raw score is the sum of the values of each scored question and ranges from 0 to 52.
A higher score indicates less fatigue.
|
Baseline, Week 105
|
|
Time to the Composite Kidney Failure Endpoint
Time Frame: Up to approximately 36 months
|
Time to the composite kidney failure endpoint is defined as receipt of kidney transplantation, need for kidney replacement therapy, or a sustained decline in eGFR of ≥ 30% or a sustained eGFR < 15 milliliters/minutes/1.73m^2
(mL/min/1.73m^
2) over at least 4 weeks (both eGFR criteria requires two consecutive central laboratory eGFR values meeting criteria ≥ 4 weeks apart), whichever occurs first, without the receipt of other immunosuppressive or background therapies for the treatment of IgAN.
|
Up to approximately 36 months
|
|
Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 36 months
|
Up to approximately 36 months
|
|
|
Plasma Concentration of Sefaxersen
Time Frame: Up to approximately 36 months
|
Up to approximately 36 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Symptoms and Health-Related Quality of Life at Week 105 as Assessed Using the RAND Kidney Disease and Quality of Life 36-Item (KDQOL-36) Short Form
Time Frame: Baseline, Week 105
|
The RAND KDQOL-36 is an abbreviated questionnaire that combines the generic and disease-specific components to assess participant's health-related quality of life.
This 36-item questionnaire includes the RAND 12, Version 1 (12 items) and 3 disease-related domains, symptoms/problems (12 items), burden of kidney disease (4 items), and effects of kidney disease (8 items).
It uses a recall of 4 weeks, and items are assessed on 3- to 5-point Likert scales or with a dichotomous response option.
Higher score indicates better health.
The raw scores are transformed linearly to a range of 0 to 100, with higher scores indicating better health.
|
Baseline, Week 105
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tekendo-Ngongang C, Gleeson JG, Mignon L. Treating the Untreatable: Antisense Oligonucleotides as an Individualized Therapy for Rare Genetic Kidney Diseases. J Am Soc Nephrol. 2024 Dec 1;35(12):1774-1777. doi: 10.1681/ASN.0000000532. Epub 2024 Sep 27. No abstract available.
- Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2023
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
March 31, 2029
Study Registration Dates
First Submitted
March 22, 2023
First Submitted That Met QC Criteria
March 22, 2023
First Posted (Actual)
April 4, 2023
Study Record Updates
Last Update Posted (Actual)
May 11, 2026
Last Update Submitted That Met QC Criteria
May 8, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
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
- Counterfeit Drugs
Other Study ID Numbers
- WA43966
- 2022-502102-32-00 (Ctis: EU Clinical Trial Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
For eligible studies, qualified researchers may request access to individual patient level clinical data.
See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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