Uno studio per valutare l'efficacia e la sicurezza di RO7434656 nei partecipanti con nefropatia primaria da immunoglobulina A (IgA) ad alto rischio di progressione (IMAGINATION)
27 ottobre 2026 aggiornato da: Hoffmann-La Roche
Uno studio di fase III, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di RO7434656, un inibitore antisenso del fattore B del complemento, in pazienti con nefropatia da IgA primaria ad alto rischio di progressione
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.
Panoramica dello studio
Stato
Stato
Attivo, non reclutante
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
Iscrizione
459
Fase
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Ciudad Autonoma Buenos Aires, Argentina, C1425AGC
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
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Ciudad Autonoma Buenos Aires, Argentina, C1426ABP
- Consultorios Médicos Dr. Doreski
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Córdoba, Argentina, X5000JHQ
- Sanatorio Allende
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Córdoba, Argentina, 5000
- Sanatorio Mayo Privado
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Rosario, Argentina, S2013DTC
- Instituto Medico de la Fundacion Estudios Clinicos
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New South Wales
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Kingswood, New South Wales, Australia, 02747
- Nepean Hospital
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Kogarah, New South Wales, Australia, 2217
- St George Hospital
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Liverpool, New South Wales, Australia, 2170
- Liverpool Hospital
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Queensland
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Woolloongabba, Queensland, Australia, 4102
- Princess Alexandra Hospital
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South Australia
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Adelaide, South Australia, Australia, SA5000
- Royal Adelaide Hospital
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Victoria
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Parkville, Victoria, Australia, 3050
- Royal Melbourne Hospital
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St Albans, Victoria, Australia, 3021
- Sunshine Hospital
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Rio de Janeiro, Brasile, 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, Brasile, 30150-221
- Santa Casa de Misericordia de Belo Horizonte - PPDS
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Belo Horizonte, Minas Gerais, Brasile, 30150
- Freire Pesquisa Clinica
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasile, 90035-903
- Hospital de Clinicas de Porto Alegre HCPA PPDS
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São Paulo
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São Paulo, São Paulo, Brasile, 01246
- Faculdade de Medicina da Universidade de Sao Paulo
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São Paulo, São Paulo, Brasile, 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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Hradec Králové, Cechia, 500 05
- Fakultni nemocnice Hradec Kralove
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Prague, Cechia, 12808
- Vseobecna fakultni nemocnice v Praze
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Beijing, Cina, 100044
- Peking University People's Hospital
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Beijing, Cina, 100034
- Peking University First Hospital
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Changzhou, Cina, 213003
- Changzhou First People's Hospital
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Chengdu, Cina, 610041
- West China Hospital, Sichuan University
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Chengdu, Cina, 610072
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Guangzhou, Cina, 510080
- Guangdong Provincial People's Hospital
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Hangzhou, Cina, 310016
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
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Hangzhou, Cina, 310014
- Zhejiang Provincial People?s Hospital
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Nanchang, Cina, 330000
- The First Affiliated Hospital of Nanchang University
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Nanjing, Cina, 210003
- The Second Affiliated Hospital of Nanjing Medical University
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Ningbo, Cina, 315000
- Ningbo No.2 Hospital
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Shanghai, Cina, 200025
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
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Shanghai, Cina
- Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
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Shenzhen, Cina, 518020
- Shenzhen People's Hospital
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Shenzhen, Cina, 518053
- The University of Hong Kong - Shenzhen Hospital
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Suzhou, Cina, 215004
- The Second Affiliated Hospital of Soochow University
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Wuhan, Cina, 430060
- Renmin Hospital of Wuhan University
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Xi'an, Cina, 710061
- The First Affiliated Hospital of Xian Jiao Tong University
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Yinchuan, Cina, 750004
- General Hospital of Ningxia Medical University
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Zhenjiang, Cina, 212001
- Affiliated Hospital of Jiangsu University
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 000000
- Beijing Friendship Hospital, Capital Medical University - PPDS
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Hebei
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Cangzhou Shi, Hebei, Cina, 060001
- Cangzhou Central Hospital
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Shijiazhuang, Hebei, Cina, 050031
- The First Hospital of Hebei Medical University
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Jiangsu
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Wuxi, Jiangsu, Cina, 214023
- Wuxi People's Hospital
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Anyang-si, Corea del Sud, 14068
- Hallym University Sacred Heart Hospital
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Bucheon-si, Corea del Sud, 420-767
- Soon Chun Hyang University Hospital Bucheon
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Cheongju-si, Corea del Sud, 28644
- Chungbuk National University Hospital
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Gyeonggi-do, Corea del Sud, 443-380
- Ajou University Hospital
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Seongnam-si, Corea del Sud, 13620
- Seoul National University Bundang Hospital
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Seongnam-si, Corea del Sud, 13496
- CHA Bundang Medical Center, CHA University
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Seoul, Corea del Sud, 03080
- Seoul National University Hospital
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Seoul, Corea del Sud, 06351
- Samsung Medical Center
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Seoul, Corea del Sud, 05030
- Konkuk University Medical Center
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Seoul, Corea del Sud, 05278
- Gangdong Kyung Hee University Hospital
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Seoul, Corea del Sud, 156-707
- SMG-SNU Boramae Medical Center
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Annonay, Francia, 07103
- Centre Hospitalier
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Boulogne-sur-Mer, Francia, 62200
- CHU Boulogne sur Mer
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Paris, Francia, 75020
- Hopital Tenon
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Toulouse, Francia, 31059
- Hôpital de Rangueil
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Aachen, Germania, 52074
- Universitatsklinikum der RWTH Aachen
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Berlin, Germania, 12101
- St. Joseph-Krankenhaus
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Cologne, Germania, 51109
- Klinikum Koln-Merheim
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Hanover, Germania, 30625
- Medizinische Hochschule Hannover
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Mainz, Germania, 55101
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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Stuttgart, Germania, 70376
- Robert-Bosch-Krankenhaus
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Villingen-Schwenningen, Germania, 78052
- Nephrologisches Zentrum Villingen-Schwenningen
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Saxony
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Leipzig, Saxony, Germania, 04103
- Universitätsklinikum Leipzig
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Aichi, Giappone, 470-1192
- Fujita Health University Hospital
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Aomori, Giappone, 036-8563
- Hirosaki University Hospital
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Chiba, Giappone, 279-0021
- Juntendo University Urayasu Hospital
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Chūō, Giappone, 409-3821
- University of Yamanashi Hospital
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Ehime, Giappone, 790-8524
- Matsuyama Red Cross Hospital
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Fukuoka, Giappone, 815-8555
- Japanese Red Cross Fukuoka Hospital
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Hiroshima, Giappone, 734-8551
- Hiroshima University Hospital
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Hokkaido, Giappone, 060-8648
- Hokkaido University Hospital
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Hyōgo, Giappone, 663-8241
- Hyogo Prefectural Nishinomiya General Medical Center
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Ishikawa, Giappone, 920-0293
- Kanazawa Medical University Hospital
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Kashihara, Giappone, 634-8522
- Nara Medical University Hospital
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Kumamoto, Giappone, 860-8556
- Kumamoto University Hospital
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Miyagi, Giappone, 980-8574
- Tohoku University Hospital
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Nara, Giappone, 630-8054
- Nara Prefecture General Medical Center
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Okayama, Giappone, 701-1192
- National Hospital Organization Okayama Medical Center
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Suita, Giappone, 565-0871
- Osaka University Hospital
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Tokyo, Giappone, 162-8666
- Tokyo Women's Medical University Hospital
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Tokyo, Giappone, 113-8431
- Juntendo University Hospital
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Tokyo, Giappone, 105-8471
- The Jikei University Hospital
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Tokyo, Giappone, 177-8521
- Juntendo University Nerima Hospital, department of renal and hypertension
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Tsukuba, Giappone, 305-8576
- University of Tsukuba Hospital
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Ube, Giappone, 755-8505
- Yamaguchi University Hospital
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Heraklion, Grecia, 71110
- University General Hospital of Heraklion
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Heraklion, Grecia, 714 09
- Venizeleio General Hospital of Heraklion
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Pátrai, Grecia, 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, Italia, 70124
- Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
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Campania
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Naples, Campania, Italia, 80131
- Azienda Ospedaliera Universitaria Federico II
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italia, 40138
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
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Liguria
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Genoa, Liguria, Italia, 16132
- Ospedale Policlinico San Martino
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Lombardy
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Pavia, Lombardy, Italia, 27100
- IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit
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Piedmont
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Turin, Piedmont, Italia, 10154
- Ospedale San Giovanni Bosco
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Ampang, Malaysia, 68000
- Hospital Ampang
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Miri, Malaysia, 98000
- Miri Hospital
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FED. Territory of Kuala Lumpur
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Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia, 50586
- Hospital Kuala Lumpur
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Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
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Pahang
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Kuantan, Pahang, Malaysia, 25100
- Hospital Tengku Ampuan Afzan
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Seri Manjong, Pahang, Malaysia, 32040
- Hospital Seri Manjung
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Perak
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Taiping, Perak, Malaysia, 34000
- Taiping Hospital
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Sarawak
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Sibu, Sarawak, Malaysia, 96000
- Hospital Sibu
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Aguascalientes
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Fracc Lomas Del Campestre, Aguascalientes, Messico, 20129
- Clinica San Cosme
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Michoacán
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Morelia, Michoacán, Messico, 58260
- Centro de Investigacion Clinica Chapultepec S. A. de C. V.
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Morelos
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Cuernavaca, Morelos, Messico, 62448
- Instituto Mexicano de Trasplantes
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Krakow, Polonia, 31-559
- SCM Clinic - Prywatny Szpital Specjalistyczny
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Lodz, Polonia, 92-213
- SPZOZ Centralny Szpital Klin
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Opole, Polonia, 45401
- Uniwersytecki Szpital Kliniczny w Opolu
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Poznan, Polonia, 60-355
- Uniwersytecki Szpital Kliniczny w Poznaniu - Przybyszewskiego 49
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Warsaw, Polonia, 02-006
- Szpital Kliniczny Dzieciatka Jezus
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Cambridge, Regno Unito, CB2 0QQ
- Addenbrookes Hospital
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Leicester, Regno Unito, LE5 4PW
- Leicester General Hospital
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London, Regno Unito, SE1 9RT
- Guys and St Thomas Hospital
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London, Regno Unito, SE5 9RS
- Kings College Hospital
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Oxford, Regno Unito, OX3 7LE
- Churchill Hospital
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Salford, Regno Unito, M6 8HD
- Salford Royal Hospital
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Singapore, Singapore, 169608
- Singapore General Hospital
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Singapore, Singapore, 119074
- National University Hospital
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Singapore, Singapore, 308433
- Tan Tock Seng Hospital
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Singapore, Singapore, 529889
- Changi General Hospital
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Barcelona, Spagna, 08035
- Hospital Universitario Vall d'Hebron - PPDS
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Madrid, Spagna, 28046
- Hospital Universitario La Paz - PPDS
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Seville, Spagna, 41013
- Hospital Universitario Virgen del Rocio - PPDS
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Lerida
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Lleida, Lerida, Spagna, 25198
- Hospital Universitari Arnau de Vilanova
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233
- UAB Nephrology Research Clinic
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California
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Glendale, California, Stati Uniti, 91206-4032
- Kidney Disease Medical Group Inc-1505 Wilson Ter
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Los Angeles, California, Stati Uniti, 90022
- Academic Medical Research Institute - Los Angeles
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Los Angeles, California, Stati Uniti, 90095-8361
- UCLA University of California Los Angeles
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San Dimas, California, Stati Uniti, 91773
- North America Research Institute-San Dimas
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Florida
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Orlando, Florida, Stati Uniti, 32806
- Central Florida Kidney Specialists
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West Miami, Florida, Stati Uniti, 33144
- L&C Professional Medical Research Institute
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Georgia
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Acworth, Georgia, Stati Uniti, 30101
- Cowry Medical Group LLC
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Idaho
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Idaho Falls, Idaho, Stati Uniti, 83402
- Care Institute Idaho Kidney Institute
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Illinois
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Hinsdale, Illinois, Stati Uniti, 60521
- Nephrology Associates of Northern Illinois
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Massachussets General Hospital
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Nevada
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Reno, Nevada, Stati Uniti, 89511
- Sierra Nevada Nephrology Consultants
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North Carolina
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Raleigh, North Carolina, Stati Uniti, 27609
- North Carolina Nephrology, PA
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Texas
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Dallas, Texas, Stati Uniti, 75231
- Texas Kidney Institute - Dallas
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Houston, Texas, Stati Uniti, 77054
- Prolato Clinical Research Center
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Houston, Texas, Stati Uniti, 077099
- Pioneer Research Solutions
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Katy, Texas, Stati Uniti, 77449
- R & H Clinical Research
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McKinney, Texas, Stati Uniti, 75071
- Revival Research Institute - McKinney
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Virginia
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Fairfax, Virginia, Stati Uniti, 22033
- Nephrology Associates of Northern Virginia Inc
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Richmond, Virginia, Stati Uniti, 23298
- Virginia Commonwealth University
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Changhua, Taiwan, 500
- Changhua Christian Hospital
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Kaohsiung City, Taiwan, 83301
- Chang Gung Medical Foundation
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Taipei, Taiwan, 220
- Far Eastern Memorial Hospital
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Taoyuan City, Taiwan, 333
- Chang Gung Memorial Hospital, Linkou
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Xitun Dist., Taiwan, 40705
- Taichung Veterans General Hospital
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Zhongshan Dist., Taiwan, 10449
- Mackay Memorial Hospital-Taipei branch
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Numero di armi
2
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
|
|
Comparatore 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37
Lasso di tempo: Baseline, Week 37
|
UPCR will be assessed in urine sampled over 24 hours. |
Baseline, Week 37
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentuale di partecipanti con eventi avversi emergenti per il trattamento (Teaes)
Lasso di tempo: Fino a circa 36 mesi
|
Fino a circa 36 mesi
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|
|
Concentrazione plasmatica di Sefaxersen
Lasso di tempo: Fino a circa 36 mesi
|
Fino a circa 36 mesi
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Percentage of Participants Achieving Hematuria Resolution at Week 37
Lasso di tempo: At Week 37
|
At Week 37
|
|
|
Estimated Glomerular Filtration Rate (eGFR) Slope at Week 105 from Baseline
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Altre misure di risultato
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Clinical Trials, Hoffmann-La Roche
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
8 agosto 2023
Completamento primario (Stimato)
Completamento primario
25 maggio 2028
Completamento dello studio (Stimato)
Completamento dello studio
31 agosto 2029
Date di iscrizione allo studio
Primo inviato
Primo inviato
22 marzo 2023
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
22 marzo 2023
Primo Inserito (Effettivo)
Primo Inserito
4 aprile 2023
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
28 ottobre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 ottobre 2026
Ultimo verificato
Ultimo verificato
1 ottobre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- WA43966
- 2022-502102-32-00 (Ctis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .