Un estudio para evaluar la eficacia y la seguridad de RO7434656 en participantes con nefropatía primaria por inmunoglobulina A (IgA) con alto riesgo de progresión (IMAGINATION)
27 de octubre de 2026 actualizado por: Hoffmann-La Roche
Estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de RO7434656, un inhibidor antisentido del factor B del complemento, en pacientes con nefropatía primaria por IgA con alto riesgo de progresión
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.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
459
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Aachen, Alemania, 52074
- Universitatsklinikum der RWTH Aachen
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Berlin, Alemania, 12101
- St. Joseph-Krankenhaus
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Cologne, Alemania, 51109
- Klinikum Koln-Merheim
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Hanover, Alemania, 30625
- Medizinische Hochschule Hannover
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Mainz, Alemania, 55101
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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Stuttgart, Alemania, 70376
- Robert-Bosch-Krankenhaus
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Villingen-Schwenningen, Alemania, 78052
- Nephrologisches Zentrum Villingen-Schwenningen
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Saxony
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Leipzig, Saxony, Alemania, 04103
- Universitätsklinikum Leipzig
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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, Brasil, 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, Brasil, 30150-221
- Santa Casa de Misericordia de Belo Horizonte - PPDS
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Belo Horizonte, Minas Gerais, Brasil, 30150
- Freire Pesquisa Clinica
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
- Hospital de Clinicas de Porto Alegre HCPA PPDS
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São Paulo
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São Paulo, São Paulo, Brasil, 01246
- Faculdade de Medicina da Universidade de Sao Paulo
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São Paulo, São Paulo, Brasil, 04038-002
- Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos
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Québec, Canadá, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 1M9
- Vancouver General Hospital
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Nova Scotia
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Sydney, Nova Scotia, Canadá, B1P 1P3
- Cape Breton Regional Hospital
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Ontario
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London, Ontario, Canadá, N6A 5W9
- London Health Sciences Centre · Victoria Hospital
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Toronto, Ontario, Canadá, M4N 3M5
- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canadá, H3G 1A4
- Montreal General Hospital
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Hradec Králové, Chequia, 500 05
- Fakultni nemocnice Hradec Kralove
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Prague, Chequia, 12808
- Vseobecna fakultni nemocnice v Praze
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Anyang-si, Corea del Sur, 14068
- Hallym University Sacred Heart Hospital
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Bucheon-si, Corea del Sur, 420-767
- Soon Chun Hyang University Hospital Bucheon
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Cheongju-si, Corea del Sur, 28644
- Chungbuk National University Hospital
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Gyeonggi-do, Corea del Sur, 443-380
- Ajou University Hospital
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Seongnam-si, Corea del Sur, 13620
- Seoul National University Bundang Hospital
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Seongnam-si, Corea del Sur, 13496
- CHA Bundang Medical Center, CHA University
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Seoul, Corea del Sur, 03080
- Seoul National University Hospital
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Seoul, Corea del Sur, 06351
- Samsung Medical Center
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Seoul, Corea del Sur, 05030
- Konkuk University Medical Center
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Seoul, Corea del Sur, 05278
- Gangdong Kyung Hee University Hospital
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Seoul, Corea del Sur, 156-707
- SMG-SNU Boramae Medical Center
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Barcelona, España, 08035
- Hospital Universitario Vall d'Hebron - PPDS
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Madrid, España, 28046
- Hospital Universitario La Paz - PPDS
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Seville, España, 41013
- Hospital Universitario Virgen del Rocio - PPDS
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Lerida
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Lleida, Lerida, España, 25198
- Hospital Universitari Arnau de Vilanova
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- UAB Nephrology Research Clinic
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California
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Glendale, California, Estados Unidos, 91206-4032
- Kidney Disease Medical Group Inc-1505 Wilson Ter
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Los Angeles, California, Estados Unidos, 90022
- Academic Medical Research Institute - Los Angeles
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Los Angeles, California, Estados Unidos, 90095-8361
- UCLA University of California Los Angeles
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San Dimas, California, Estados Unidos, 91773
- North America Research Institute-San Dimas
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Florida
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Orlando, Florida, Estados Unidos, 32806
- Central Florida Kidney Specialists
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West Miami, Florida, Estados Unidos, 33144
- L&C Professional Medical Research Institute
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Georgia
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Acworth, Georgia, Estados Unidos, 30101
- Cowry Medical Group LLC
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Idaho
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Idaho Falls, Idaho, Estados Unidos, 83402
- Care Institute Idaho Kidney Institute
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Illinois
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Hinsdale, Illinois, Estados Unidos, 60521
- Nephrology Associates of Northern Illinois
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachussets General Hospital
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Nevada
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Reno, Nevada, Estados Unidos, 89511
- Sierra Nevada Nephrology Consultants
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North Carolina
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Raleigh, North Carolina, Estados Unidos, 27609
- North Carolina Nephrology, PA
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Texas
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Dallas, Texas, Estados Unidos, 75231
- Texas Kidney Institute - Dallas
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Houston, Texas, Estados Unidos, 77054
- Prolato Clinical Research Center
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Houston, Texas, Estados Unidos, 077099
- Pioneer Research Solutions
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Katy, Texas, Estados Unidos, 77449
- R & H Clinical Research
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McKinney, Texas, Estados Unidos, 75071
- Revival Research Institute - McKinney
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Virginia
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Fairfax, Virginia, Estados Unidos, 22033
- Nephrology Associates of Northern Virginia Inc
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
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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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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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Aichi, Japón, 470-1192
- Fujita Health University Hospital
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Aomori, Japón, 036-8563
- Hirosaki University Hospital
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Chiba, Japón, 279-0021
- Juntendo University Urayasu Hospital
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Chūō, Japón, 409-3821
- University of Yamanashi Hospital
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Ehime, Japón, 790-8524
- Matsuyama Red Cross Hospital
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Fukuoka, Japón, 815-8555
- Japanese Red Cross Fukuoka Hospital
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Hiroshima, Japón, 734-8551
- Hiroshima University Hospital
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Hokkaido, Japón, 060-8648
- Hokkaido University Hospital
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Hyōgo, Japón, 663-8241
- Hyogo Prefectural Nishinomiya General Medical Center
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Ishikawa, Japón, 920-0293
- Kanazawa Medical University Hospital
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Kashihara, Japón, 634-8522
- Nara Medical University Hospital
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Kumamoto, Japón, 860-8556
- Kumamoto University Hospital
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Miyagi, Japón, 980-8574
- Tohoku University Hospital
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Nara, Japón, 630-8054
- Nara Prefecture General Medical Center
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Okayama, Japón, 701-1192
- National Hospital Organization Okayama Medical Center
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Suita, Japón, 565-0871
- Osaka University Hospital
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Tokyo, Japón, 162-8666
- Tokyo Women's Medical University Hospital
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Tokyo, Japón, 113-8431
- Juntendo University Hospital
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Tokyo, Japón, 105-8471
- The Jikei University Hospital
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Tokyo, Japón, 177-8521
- Juntendo University Nerima Hospital, department of renal and hypertension
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Tsukuba, Japón, 305-8576
- University of Tsukuba Hospital
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Ube, Japón, 755-8505
- Yamaguchi University Hospital
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Ampang, Malasia, 68000
- Hospital Ampang
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Miri, Malasia, 98000
- Miri Hospital
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FED. Territory of Kuala Lumpur
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Kuala Lumpur, FED. Territory of Kuala Lumpur, Malasia, 50586
- Hospital Kuala Lumpur
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Kuala Lumpur, FED. Territory of Kuala Lumpur, Malasia, 59100
- University Malaya Medical Centre
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Pahang
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Kuantan, Pahang, Malasia, 25100
- Hospital Tengku Ampuan Afzan
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Seri Manjong, Pahang, Malasia, 32040
- Hospital Seri Manjung
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Perak
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Taiping, Perak, Malasia, 34000
- Taiping Hospital
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Sarawak
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Sibu, Sarawak, Malasia, 96000
- Hospital Sibu
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Aguascalientes
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Fracc Lomas Del Campestre, Aguascalientes, México, 20129
- Clinica San Cosme
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Michoacán
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Morelia, Michoacán, México, 58260
- Centro de Investigacion Clinica Chapultepec S. A. de C. V.
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Morelos
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Cuernavaca, Morelos, México, 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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Beijing, Porcelana, 100044
- Peking University People's Hospital
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Beijing, Porcelana, 100034
- Peking University First Hospital
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Changzhou, Porcelana, 213003
- Changzhou First People's Hospital
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Chengdu, Porcelana, 610041
- West China Hospital, Sichuan University
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Chengdu, Porcelana, 610072
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Guangzhou, Porcelana, 510080
- Guangdong Provincial People's Hospital
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Hangzhou, Porcelana, 310016
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
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Hangzhou, Porcelana, 310014
- Zhejiang Provincial People?s Hospital
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Nanchang, Porcelana, 330000
- The First Affiliated Hospital of Nanchang University
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Nanjing, Porcelana, 210003
- The Second Affiliated Hospital of Nanjing Medical University
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Ningbo, Porcelana, 315000
- Ningbo No.2 Hospital
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Shanghai, Porcelana, 200025
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
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Shanghai, Porcelana
- Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
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Shenzhen, Porcelana, 518020
- Shenzhen People's Hospital
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Shenzhen, Porcelana, 518053
- The University of Hong Kong - Shenzhen Hospital
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Suzhou, Porcelana, 215004
- The Second Affiliated Hospital of Soochow University
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Wuhan, Porcelana, 430060
- Renmin Hospital of Wuhan University
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Xi'an, Porcelana, 710061
- The First Affiliated Hospital of Xian Jiao Tong University
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Yinchuan, Porcelana, 750004
- General Hospital of Ningxia Medical University
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Zhenjiang, Porcelana, 212001
- Affiliated Hospital of Jiangsu University
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 000000
- Beijing Friendship Hospital, Capital Medical University - PPDS
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Hebei
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Cangzhou Shi, Hebei, Porcelana, 060001
- Cangzhou Central Hospital
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Shijiazhuang, Hebei, Porcelana, 050031
- The First Hospital of Hebei Medical University
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Jiangsu
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Wuxi, Jiangsu, Porcelana, 214023
- Wuxi People's Hospital
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Cambridge, Reino Unido, CB2 0QQ
- Addenbrookes Hospital
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Leicester, Reino Unido, LE5 4PW
- Leicester General Hospital
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London, Reino Unido, SE1 9RT
- Guys and St Thomas Hospital
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London, Reino Unido, SE5 9RS
- Kings College Hospital
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Oxford, Reino Unido, OX3 7LE
- Churchill Hospital
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Salford, Reino Unido, M6 8HD
- Salford Royal Hospital
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Singapore, Singapur, 169608
- Singapore General Hospital
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Singapore, Singapur, 119074
- National University Hospital
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Singapore, Singapur, 308433
- Tan Tock Seng Hospital
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Singapore, Singapur, 529889
- Changi General Hospital
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Changhua, Taiwán, 500
- Changhua Christian Hospital
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Kaohsiung City, Taiwán, 83301
- Chang Gung Medical Foundation
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Taichung, Taiwán, 40447
- China Medical University Hospital
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Taipei, Taiwán, 220
- Far Eastern Memorial Hospital
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Taoyuan City, Taiwán, 333
- Chang Gung Memorial Hospital, Linkou
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Xitun Dist., Taiwán, 40705
- Taichung Veterans General Hospital
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Zhongshan Dist., Taiwán, 10449
- Mackay Memorial Hospital-Taipei branch
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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 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.
Otros nombres:
|
|
Comparador de placebos: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37
Periodo de tiempo: Baseline, Week 37
|
UPCR will be assessed in urine sampled over 24 hours. |
Baseline, Week 37
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Porcentaje de participantes con eventos adversos emergentes del tratamiento (TEAES)
Periodo de tiempo: Hasta aproximadamente 36 meses
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Hasta aproximadamente 36 meses
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Concentración plasmática de sefaxersen
Periodo de tiempo: Hasta aproximadamente 36 meses
|
Hasta aproximadamente 36 meses
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|
Percentage of Participants Achieving Hematuria Resolution at Week 37
Periodo de tiempo: At Week 37
|
At Week 37
|
|
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Estimated Glomerular Filtration Rate (eGFR) Slope at Week 105 from Baseline
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Clinical Trials, Hoffmann-La Roche
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de agosto de 2023
Finalización primaria (Estimado)
25 de mayo de 2028
Finalización del estudio (Estimado)
31 de agosto de 2029
Fechas de registro del estudio
Enviado por primera vez
22 de marzo de 2023
Primero enviado que cumplió con los criterios de control de calidad
22 de marzo de 2023
Publicado por primera vez (Actual)
4 de abril de 2023
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de octubre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de octubre de 2026
Última verificación
1 de octubre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Glomerulonefritis
- Nefritis
- Glomerulonefritis, IGA
Otros números de identificación del estudio
- WA43966
- 2022-502102-32-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .