Une étude pour évaluer l'efficacité et l'innocuité du RO7434656 chez les participants atteints de néphropathie primaire à immunoglobuline A (IgA) à haut risque de progression (IMAGINATION)
27 octobre 2026 mis à jour par: Hoffmann-La Roche
Une étude de phase III, multicentrique, randomisée, en double aveugle et contrôlée par placebo pour évaluer l'efficacité et l'innocuité du RO7434656, un inhibiteur antisens du facteur B du complément, chez les patients atteints de néphropathie primaire à IgA à haut risque de progression
The purpose of this study is to evaluate the efficacy, safety, & 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.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
459
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Aachen, Allemagne, 52074
- Universitatsklinikum der RWTH Aachen
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Berlin, Allemagne, 12101
- St. Joseph-Krankenhaus
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Cologne, Allemagne, 51109
- Klinikum Koln-Merheim
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Hanover, Allemagne, 30625
- Medizinische Hochschule Hannover
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Mainz, Allemagne, 55101
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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Stuttgart, Allemagne, 70376
- Robert-Bosch-Krankenhaus
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Villingen-Schwenningen, Allemagne, 78052
- Nephrologisches Zentrum Villingen-Schwenningen
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Saxony
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Leipzig, Saxony, Allemagne, 04103
- Universitätsklinikum Leipzig
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Ciudad Autonoma Buenos Aires, Argentine, C1425AGC
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
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Ciudad Autonoma Buenos Aires, Argentine, C1426ABP
- Consultorios Médicos Dr. Doreski
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Córdoba, Argentine, X5000JHQ
- Sanatorio Allende
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Córdoba, Argentine, 5000
- Sanatorio Mayo Privado
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Rosario, Argentine, S2013DTC
- Instituto Medico de la Fundacion Estudios Clinicos
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New South Wales
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Kingswood, New South Wales, Australie, 02747
- Nepean Hospital
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Kogarah, New South Wales, Australie, 2217
- St George Hospital
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Liverpool, New South Wales, Australie, 2170
- Liverpool Hospital
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Queensland
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Woolloongabba, Queensland, Australie, 4102
- Princess Alexandra Hospital
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South Australia
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Adelaide, South Australia, Australie, SA5000
- Royal Adelaide Hospital
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Victoria
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Parkville, Victoria, Australie, 3050
- Royal Melbourne Hospital
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St Albans, Victoria, Australie, 3021
- Sunshine Hospital
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Rio de Janeiro, Brésil, 22281
- Instituto D?Or Pesquisa e Ensino - Hospital Gloria D?Or
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brésil, 30150-221
- Santa Casa de Misericordia de Belo Horizonte - PPDS
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Belo Horizonte, Minas Gerais, Brésil, 30150
- Freire Pesquisa Clinica
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brésil, 90035-903
- Hospital de Clinicas de Porto Alegre HCPA PPDS
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São Paulo
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São Paulo, São Paulo, Brésil, 01246
- Faculdade de Medicina da Universidade de Sao Paulo
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São Paulo, São Paulo, Brésil, 04038-002
- Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos
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Québec, Canada, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
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Nova Scotia
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Sydney, Nova Scotia, Canada, B1P 1P3
- Cape Breton Regional Hospital
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Ontario
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London, Ontario, Canada, N6A 5W9
- London Health Sciences Centre · Victoria Hospital
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada, H3G 1A4
- Montreal General Hospital
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Beijing, Chine, 100044
- Peking University People's Hospital
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Beijing, Chine, 100034
- Peking University First Hospital
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Changzhou, Chine, 213003
- Changzhou First People's Hospital
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Chengdu, Chine, 610041
- West China Hospital, Sichuan University
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Chengdu, Chine, 610072
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Guangzhou, Chine, 510080
- Guangdong Provincial People's Hospital
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Hangzhou, Chine, 310016
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
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Hangzhou, Chine, 310014
- Zhejiang Provincial People?s Hospital
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Nanchang, Chine, 330000
- The First Affiliated Hospital of Nanchang University
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Nanjing, Chine, 210003
- The Second Affiliated Hospital of Nanjing Medical University
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Ningbo, Chine, 315000
- Ningbo No.2 Hospital
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Shanghai, Chine, 200025
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
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Shanghai, Chine
- Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
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Shenzhen, Chine, 518020
- Shenzhen People's Hospital
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Shenzhen, Chine, 518053
- The University of Hong Kong - Shenzhen Hospital
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Suzhou, Chine, 215004
- The Second Affiliated Hospital of Soochow University
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Wuhan, Chine, 430060
- Renmin Hospital of Wuhan University
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Xi'an, Chine, 710061
- The First Affiliated Hospital of Xian Jiao Tong University
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Yinchuan, Chine, 750004
- General Hospital of Ningxia Medical University
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Zhenjiang, Chine, 212001
- Affiliated Hospital of Jiangsu University
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 000000
- Beijing Friendship Hospital, Capital Medical University - PPDS
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Hebei
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Cangzhou Shi, Hebei, Chine, 060001
- Cangzhou Central Hospital
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Shijiazhuang, Hebei, Chine, 050031
- The First Hospital of Hebei Medical University
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Jiangsu
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Wuxi, Jiangsu, Chine, 214023
- Wuxi People's Hospital
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Anyang-si, Corée du Sud, 14068
- Hallym University Sacred Heart Hospital
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Bucheon-si, Corée du Sud, 420-767
- Soon Chun Hyang University Hospital Bucheon
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Cheongju-si, Corée du Sud, 28644
- Chungbuk National University Hospital
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Gyeonggi-do, Corée du Sud, 443-380
- Ajou University Hospital
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Seongnam-si, Corée du Sud, 13620
- Seoul National University Bundang Hospital
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Seongnam-si, Corée du Sud, 13496
- CHA Bundang Medical Center, CHA University
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Seoul, Corée du Sud, 03080
- Seoul National University Hospital
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Seoul, Corée du Sud, 06351
- Samsung Medical Center
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Seoul, Corée du Sud, 05030
- Konkuk University Medical Center
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Seoul, Corée du Sud, 05278
- Gangdong Kyung Hee University Hospital
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Seoul, Corée du Sud, 156-707
- SMG-SNU Boramae Medical Center
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Barcelona, Espagne, 08035
- Hospital Universitario Vall d'Hebron - PPDS
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Madrid, Espagne, 28046
- Hospital Universitario La Paz - PPDS
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Seville, Espagne, 41013
- Hospital Universitario Virgen del Rocio - PPDS
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Lerida
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Lleida, Lerida, Espagne, 25198
- Hospital Universitari Arnau de Vilanova
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Annonay, France, 07103
- Centre Hospitalier
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Boulogne-sur-Mer, France, 62200
- CHU Boulogne sur Mer
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Paris, France, 75020
- Hopital Tenon
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Toulouse, France, 31059
- Hôpital de Rangueil
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Heraklion, Grèce, 71110
- University General Hospital of Heraklion
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Heraklion, Grèce, 714 09
- Venizeleio General Hospital of Heraklion
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Pátrai, Grèce, 265 04
- University General Hospital of Patras
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Hong Kong, Hong Kong, 999077
- Queen Mary Hospital
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Apulia
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Bari, Apulia, Italie, 70124
- Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
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Campania
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Naples, Campania, Italie, 80131
- Azienda Ospedaliera Universitaria Federico II
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italie, 40138
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
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Liguria
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Genoa, Liguria, Italie, 16132
- Ospedale Policlinico San Martino
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Lombardy
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Pavia, Lombardy, Italie, 27100
- IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit
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Piedmont
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Turin, Piedmont, Italie, 10154
- Ospedale San Giovanni Bosco
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Aichi, Japon, 470-1192
- Fujita Health University Hospital
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Aomori, Japon, 036-8563
- Hirosaki University Hospital
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Chiba, Japon, 279-0021
- Juntendo University Urayasu Hospital
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Chūō, Japon, 409-3821
- University of Yamanashi Hospital
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Ehime, Japon, 790-8524
- Matsuyama Red Cross Hospital
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Fukuoka, Japon, 815-8555
- Japanese Red Cross Fukuoka Hospital
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Hiroshima, Japon, 734-8551
- Hiroshima University Hospital
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Hokkaido, Japon, 060-8648
- Hokkaido University Hospital
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Hyōgo, Japon, 663-8241
- Hyogo Prefectural Nishinomiya General Medical Center
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Ishikawa, Japon, 920-0293
- Kanazawa Medical University Hospital
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Kashihara, Japon, 634-8522
- Nara Medical University Hospital
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Kumamoto, Japon, 860-8556
- Kumamoto University Hospital
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Miyagi, Japon, 980-8574
- Tohoku University Hospital
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Nara, Japon, 630-8054
- Nara Prefecture General Medical Center
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Okayama, Japon, 701-1192
- National Hospital Organization Okayama Medical Center
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Suita, Japon, 565-0871
- Osaka University Hospital
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Tokyo, Japon, 162-8666
- Tokyo Women's Medical University Hospital
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Tokyo, Japon, 113-8431
- Juntendo University Hospital
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Tokyo, Japon, 105-8471
- The Jikei University Hospital
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Tokyo, Japon, 177-8521
- Juntendo University Nerima Hospital, department of renal and hypertension
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Tsukuba, Japon, 305-8576
- University of Tsukuba Hospital
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Ube, Japon, 755-8505
- Yamaguchi University Hospital
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Ampang, Malaisie, 68000
- Hospital Ampang
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Miri, Malaisie, 98000
- Miri Hospital
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FED. Territory of Kuala Lumpur
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Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaisie, 50586
- Hospital Kuala Lumpur
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Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaisie, 59100
- University Malaya Medical Centre
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Pahang
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Kuantan, Pahang, Malaisie, 25100
- Hospital Tengku Ampuan Afzan
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Seri Manjong, Pahang, Malaisie, 32040
- Hospital Seri Manjung
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Perak
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Taiping, Perak, Malaisie, 34000
- Taiping Hospital
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Sarawak
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Sibu, Sarawak, Malaisie, 96000
- Hospital Sibu
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Aguascalientes
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Fracc Lomas Del Campestre, Aguascalientes, Mexique, 20129
- Clinica San Cosme
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Michoacán
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Morelia, Michoacán, Mexique, 58260
- Centro de Investigacion Clinica Chapultepec S. A. de C. V.
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Morelos
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Cuernavaca, Morelos, Mexique, 62448
- Instituto Mexicano de Trasplantes
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Krakow, Pologne, 31-559
- SCM Clinic - Prywatny Szpital Specjalistyczny
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Lodz, Pologne, 92-213
- SPZOZ Centralny Szpital Klin
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Opole, Pologne, 45401
- Uniwersytecki Szpital Kliniczny w Opolu
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Poznan, Pologne, 60-355
- Uniwersytecki Szpital Kliniczny w Poznaniu - Przybyszewskiego 49
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Warsaw, Pologne, 02-006
- Szpital Kliniczny Dzieciatka Jezus
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Cambridge, Royaume-Uni, CB2 0QQ
- Addenbrookes Hospital
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Leicester, Royaume-Uni, LE5 4PW
- Leicester General Hospital
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London, Royaume-Uni, SE1 9RT
- Guys and St Thomas Hospital
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London, Royaume-Uni, SE5 9RS
- Kings College Hospital
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Oxford, Royaume-Uni, OX3 7LE
- Churchill Hospital
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Salford, Royaume-Uni, M6 8HD
- Salford Royal Hospital
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Singapore, Singapour, 169608
- Singapore General Hospital
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Singapore, Singapour, 119074
- National University Hospital
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Singapore, Singapour, 308433
- Tan Tock Seng Hospital
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Singapore, Singapour, 529889
- Changi General Hospital
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Changhua, Taïwan, 500
- Changhua Christian Hospital
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Kaohsiung City, Taïwan, 83301
- Chang Gung Medical Foundation
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Taichung, Taïwan, 40447
- China Medical University Hospital
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Taipei, Taïwan, 220
- Far Eastern Memorial Hospital
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Taoyuan City, Taïwan, 333
- Chang Gung Memorial Hospital, Linkou
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Xitun Dist., Taïwan, 40705
- Taichung Veterans General Hospital
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Zhongshan Dist., Taïwan, 10449
- Mackay Memorial Hospital-Taipei branch
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Hradec Králové, Tchéquie, 500 05
- Fakultni nemocnice Hradec Kralove
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Prague, Tchéquie, 12808
- Vseobecna fakultni nemocnice v Praze
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- UAB Nephrology Research Clinic
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California
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Glendale, California, États-Unis, 91206-4032
- Kidney Disease Medical Group Inc-1505 Wilson Ter
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Los Angeles, California, États-Unis, 90022
- Academic Medical Research Institute - Los Angeles
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Los Angeles, California, États-Unis, 90095-8361
- UCLA University of California Los Angeles
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San Dimas, California, États-Unis, 91773
- North America Research Institute-San Dimas
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Florida
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Orlando, Florida, États-Unis, 32806
- Central Florida Kidney Specialists
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West Miami, Florida, États-Unis, 33144
- L&C Professional Medical Research Institute
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Georgia
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Acworth, Georgia, États-Unis, 30101
- Cowry Medical Group LLC
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Idaho
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Idaho Falls, Idaho, États-Unis, 83402
- Care Institute Idaho Kidney Institute
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Illinois
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Hinsdale, Illinois, États-Unis, 60521
- Nephrology Associates of Northern Illinois
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachussets General Hospital
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Nevada
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Reno, Nevada, États-Unis, 89511
- Sierra Nevada Nephrology Consultants
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North Carolina
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Raleigh, North Carolina, États-Unis, 27609
- North Carolina Nephrology, PA
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Texas
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Dallas, Texas, États-Unis, 75231
- Texas Kidney Institute - Dallas
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Houston, Texas, États-Unis, 77054
- Prolato Clinical Research Center
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Houston, Texas, États-Unis, 077099
- Pioneer Research Solutions
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Katy, Texas, États-Unis, 77449
- R & H Clinical Research
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McKinney, Texas, États-Unis, 75071
- Revival Research Institute - McKinney
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Virginia
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Fairfax, Virginia, États-Unis, 22033
- Nephrology Associates of Northern Virginia Inc
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Richmond, Virginia, États-Unis, 23298
- Virginia Commonwealth University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La 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 millimetre of mercury (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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 or after the common-close timepoint, whichever occurs first. The common-close timepoint is defined as the data cut-off date for the primary analysis. |
Sefaxersen (RO7434656) will be administered as SC injection per schedule as specified in the protocol.
Autres noms:
|
|
Comparateur placebo: 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 or after the common-close timepoint, whichever occurs first. The common-close timepoint is defined as the data cut-off date for the primary analysis. |
Matching placebo will be administered as SC injection per schedule as specified in the protocol. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37
Délai: Baseline, Week 37
|
UPCR will be assessed in urine sampled over 24 hours. |
Baseline, Week 37
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pourcentage de participants avec des événements indésirables émergents du traitement (TEAES)
Délai: Jusqu'à environ 36 mois
|
Jusqu'à environ 36 mois
|
|
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Concentration plasmatique de sefaxensen
Délai: Jusqu'à environ 36 mois
|
Jusqu'à environ 36 mois
|
|
|
Percentage of Participants Achieving Hematuria Resolution at Week 37
Délai: At Week 37
|
At Week 37
|
|
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Estimated Glomerular Filtration Rate (eGFR) Slope at Week 105 from Baseline
Délai: Baseline, Week 105
|
eGFR will be calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation. |
Baseline, Week 105
|
|
Time to the Composite Kidney Failure Endpoint
Délai: 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. |
Up to approximately 36 months
|
|
Change From Baseline in Fatigue at Week 105
Délai: 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". Relevant items are reverse scored, and all items are summed up to create a total score ranging from 0 to 52, with higher scores indicative of better functioning (i.e., less fatigue). |
Baseline, Week 105
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Clinical Trials, Hoffmann-La Roche
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- Sato T, Fukase H, Ishida T, Karasawa A. A First-in-Japanese Phase 1, Double-Blind, Placebo-Controlled, Parallel-Cohort Study of Sefaxersen, an Antisense Oligonucleotide Targeting Complement Factor B, in Healthy Participants. Clin Pharmacol Drug Dev. 2026 Sep;15(9):e70097. doi: 10.1002/cpdd.70097.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
8 août 2023
Achèvement primaire (Estimé)
25 mai 2028
Achèvement de l'étude (Estimé)
31 août 2029
Dates d'inscription aux études
Première soumission
22 mars 2023
Première soumission répondant aux critères de contrôle qualité
22 mars 2023
Première publication (Réel)
4 avril 2023
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 octobre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 octobre 2026
Dernière vérification
1 octobre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- WA43966
- 2022-502102-32-00 (Ctis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .