Um estudo para avaliar a eficácia e a segurança de RO7434656 em participantes com nefropatia primária por imunoglobulina A (IgA) com alto risco de progressão (IMAGINATION)
27 de outubro de 2026 atualizado por: Hoffmann-La Roche
Um estudo de fase III, multicêntrico, randomizado, duplo-cego, controlado por placebo para avaliar a eficácia e a segurança de RO7434656, um inibidor antisense do fator B do complemento, em pacientes com nefropatia primária por IgA com alto risco de progressão
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.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
459
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Aachen, Alemanha, 52074
- Universitatsklinikum der RWTH Aachen
-
Berlin, Alemanha, 12101
- St. Joseph-Krankenhaus
-
Cologne, Alemanha, 51109
- Klinikum Koln-Merheim
-
Hanover, Alemanha, 30625
- Medizinische Hochschule Hannover
-
Mainz, Alemanha, 55101
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
-
Stuttgart, Alemanha, 70376
- Robert-Bosch-Krankenhaus
-
Villingen-Schwenningen, Alemanha, 78052
- Nephrologisches Zentrum Villingen-Schwenningen
-
-
Saxony
-
Leipzig, Saxony, Alemanha, 04103
- Universitätsklinikum Leipzig
-
-
-
-
-
Ciudad Autonoma Buenos Aires, Argentina, C1425AGC
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
-
Ciudad Autonoma Buenos Aires, Argentina, C1426ABP
- Consultorios Médicos Dr. Doreski
-
Córdoba, Argentina, X5000JHQ
- Sanatorio Allende
-
Córdoba, Argentina, 5000
- Sanatorio Mayo Privado
-
Rosario, Argentina, S2013DTC
- Instituto Medico de la Fundacion Estudios Clinicos
-
-
-
-
New South Wales
-
Kingswood, New South Wales, Austrália, 02747
- Nepean Hospital
-
Kogarah, New South Wales, Austrália, 2217
- St George Hospital
-
Liverpool, New South Wales, Austrália, 2170
- Liverpool Hospital
-
-
Queensland
-
Woolloongabba, Queensland, Austrália, 4102
- Princess Alexandra Hospital
-
-
South Australia
-
Adelaide, South Australia, Austrália, SA5000
- Royal Adelaide Hospital
-
-
Victoria
-
Parkville, Victoria, Austrália, 3050
- Royal Melbourne Hospital
-
St Albans, Victoria, Austrália, 3021
- Sunshine Hospital
-
-
-
-
-
Rio de Janeiro, Brasil, 22281
- Instituto D?Or Pesquisa e Ensino - Hospital Gloria D?Or
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brasil, 30150-221
- Santa Casa de Misericordia de Belo Horizonte - PPDS
-
Belo Horizonte, Minas Gerais, Brasil, 30150
- Freire Pesquisa Clinica
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
- Hospital de Clinicas de Porto Alegre HCPA PPDS
-
-
São Paulo
-
São Paulo, São Paulo, Brasil, 01246
- Faculdade de Medicina da Universidade de Sao Paulo
-
São Paulo, São Paulo, Brasil, 04038-002
- Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos
-
-
-
-
-
Québec, Canadá, G1R 2J6
- Centre Hospitalier Universitaire de Quebec
-
-
British Columbia
-
Vancouver, British Columbia, Canadá, V5Z 1M9
- Vancouver General Hospital
-
-
Nova Scotia
-
Sydney, Nova Scotia, Canadá, B1P 1P3
- Cape Breton Regional Hospital
-
-
Ontario
-
London, Ontario, Canadá, N6A 5W9
- London Health Sciences Centre · Victoria Hospital
-
Toronto, Ontario, Canadá, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Quebec
-
Montreal, Quebec, Canadá, H3G 1A4
- Montreal General Hospital
-
-
-
-
-
Beijing, China, 100044
- Peking University People's Hospital
-
Beijing, China, 100034
- Peking University First Hospital
-
Changzhou, China, 213003
- Changzhou First People's Hospital
-
Chengdu, China, 610041
- West China Hospital, Sichuan University
-
Chengdu, China, 610072
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
-
Guangzhou, China, 510080
- Guangdong Provincial People's Hospital
-
Hangzhou, China, 310016
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
-
Hangzhou, China, 310014
- Zhejiang Provincial People?s Hospital
-
Nanchang, China, 330000
- The First Affiliated Hospital of Nanchang University
-
Nanjing, China, 210003
- The Second Affiliated Hospital of Nanjing Medical University
-
Ningbo, China, 315000
- Ningbo No.2 Hospital
-
Shanghai, China, 200025
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
-
Shanghai, China
- Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
-
Shenzhen, China, 518020
- Shenzhen People's Hospital
-
Shenzhen, China, 518053
- The University of Hong Kong - Shenzhen Hospital
-
Suzhou, China, 215004
- The Second Affiliated Hospital of Soochow University
-
Wuhan, China, 430060
- Renmin Hospital of Wuhan University
-
Xi'an, China, 710061
- The First Affiliated Hospital of Xian Jiao Tong University
-
Yinchuan, China, 750004
- General Hospital of Ningxia Medical University
-
Zhenjiang, China, 212001
- Affiliated Hospital of Jiangsu University
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 000000
- Beijing Friendship Hospital, Capital Medical University - PPDS
-
-
Hebei
-
Cangzhou Shi, Hebei, China, 060001
- Cangzhou Central Hospital
-
Shijiazhuang, Hebei, China, 050031
- The First Hospital of Hebei Medical University
-
-
Jiangsu
-
Wuxi, Jiangsu, China, 214023
- Wuxi People's Hospital
-
-
-
-
-
Singapore, Cingapura, 169608
- Singapore General Hospital
-
Singapore, Cingapura, 119074
- National University Hospital
-
Singapore, Cingapura, 308433
- Tan Tock Seng Hospital
-
Singapore, Cingapura, 529889
- Changi General Hospital
-
-
-
-
-
Anyang-si, Coréia do Sul, 14068
- Hallym University Sacred Heart Hospital
-
Bucheon-si, Coréia do Sul, 420-767
- Soon Chun Hyang University Hospital Bucheon
-
Cheongju-si, Coréia do Sul, 28644
- Chungbuk National University Hospital
-
Gyeonggi-do, Coréia do Sul, 443-380
- Ajou University Hospital
-
Seongnam-si, Coréia do Sul, 13620
- Seoul National University Bundang Hospital
-
Seongnam-si, Coréia do Sul, 13496
- CHA Bundang Medical Center, CHA University
-
Seoul, Coréia do Sul, 03080
- Seoul National University Hospital
-
Seoul, Coréia do Sul, 06351
- Samsung Medical Center
-
Seoul, Coréia do Sul, 05030
- Konkuk University Medical Center
-
Seoul, Coréia do Sul, 05278
- Gangdong Kyung Hee University Hospital
-
Seoul, Coréia do Sul, 156-707
- SMG-SNU Boramae Medical Center
-
-
-
-
-
Barcelona, Espanha, 08035
- Hospital Universitario Vall d'Hebron - PPDS
-
Madrid, Espanha, 28046
- Hospital Universitario La Paz - PPDS
-
Seville, Espanha, 41013
- Hospital Universitario Virgen del Rocio - PPDS
-
-
Lerida
-
Lleida, Lerida, Espanha, 25198
- Hospital Universitari Arnau de Vilanova
-
-
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos, 35233
- UAB Nephrology Research Clinic
-
-
California
-
Glendale, California, Estados Unidos, 91206-4032
- Kidney Disease Medical Group Inc-1505 Wilson Ter
-
Los Angeles, California, Estados Unidos, 90022
- Academic Medical Research Institute - Los Angeles
-
Los Angeles, California, Estados Unidos, 90095-8361
- UCLA University of California Los Angeles
-
San Dimas, California, Estados Unidos, 91773
- North America Research Institute-San Dimas
-
-
Florida
-
Orlando, Florida, Estados Unidos, 32806
- Central Florida Kidney Specialists
-
West Miami, Florida, Estados Unidos, 33144
- L&C Professional Medical Research Institute
-
-
Georgia
-
Acworth, Georgia, Estados Unidos, 30101
- Cowry Medical Group LLC
-
-
Idaho
-
Idaho Falls, Idaho, Estados Unidos, 83402
- Care Institute Idaho Kidney Institute
-
-
Illinois
-
Hinsdale, Illinois, Estados Unidos, 60521
- Nephrology Associates of Northern Illinois
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02114
- Massachussets General Hospital
-
-
Nevada
-
Reno, Nevada, Estados Unidos, 89511
- Sierra Nevada Nephrology Consultants
-
-
North Carolina
-
Raleigh, North Carolina, Estados Unidos, 27609
- North Carolina Nephrology, PA
-
-
Texas
-
Dallas, Texas, Estados Unidos, 75231
- Texas Kidney Institute - Dallas
-
Houston, Texas, Estados Unidos, 77054
- Prolato Clinical Research Center
-
Houston, Texas, Estados Unidos, 077099
- Pioneer Research Solutions
-
Katy, Texas, Estados Unidos, 77449
- R & H Clinical Research
-
McKinney, Texas, Estados Unidos, 75071
- Revival Research Institute - McKinney
-
-
Virginia
-
Fairfax, Virginia, Estados Unidos, 22033
- Nephrology Associates of Northern Virginia Inc
-
Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
-
-
-
-
-
Annonay, França, 07103
- Centre Hospitalier
-
Boulogne-sur-Mer, França, 62200
- CHU Boulogne sur Mer
-
Paris, França, 75020
- Hopital Tenon
-
Toulouse, França, 31059
- Hôpital de Rangueil
-
-
-
-
-
Heraklion, Grécia, 71110
- University General Hospital of Heraklion
-
Heraklion, Grécia, 714 09
- Venizeleio General Hospital of Heraklion
-
Pátrai, Grécia, 265 04
- University General Hospital of Patras
-
-
-
-
-
Hong Kong, Hong Kong, 999077
- Queen Mary Hospital
-
-
-
-
Apulia
-
Bari, Apulia, Itália, 70124
- Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
-
-
Campania
-
Naples, Campania, Itália, 80131
- Azienda Ospedaliera Universitaria Federico II
-
-
Emilia-Romagna
-
Bologna, Emilia-Romagna, Itália, 40138
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
-
-
Liguria
-
Genoa, Liguria, Itália, 16132
- Ospedale Policlinico San Martino
-
-
Lombardy
-
Pavia, Lombardy, Itália, 27100
- IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit
-
-
Piedmont
-
Turin, Piedmont, Itália, 10154
- Ospedale San Giovanni Bosco
-
-
-
-
-
Aichi, Japão, 470-1192
- Fujita Health University Hospital
-
Aomori, Japão, 036-8563
- Hirosaki University Hospital
-
Chiba, Japão, 279-0021
- Juntendo University Urayasu Hospital
-
Chūō, Japão, 409-3821
- University of Yamanashi Hospital
-
Ehime, Japão, 790-8524
- Matsuyama Red Cross Hospital
-
Fukuoka, Japão, 815-8555
- Japanese Red Cross Fukuoka Hospital
-
Hiroshima, Japão, 734-8551
- Hiroshima University Hospital
-
Hokkaido, Japão, 060-8648
- Hokkaido University Hospital
-
Hyōgo, Japão, 663-8241
- Hyogo Prefectural Nishinomiya General Medical Center
-
Ishikawa, Japão, 920-0293
- Kanazawa Medical University Hospital
-
Kashihara, Japão, 634-8522
- Nara Medical University Hospital
-
Kumamoto, Japão, 860-8556
- Kumamoto University Hospital
-
Miyagi, Japão, 980-8574
- Tohoku University Hospital
-
Nara, Japão, 630-8054
- Nara Prefecture General Medical Center
-
Okayama, Japão, 701-1192
- National Hospital Organization Okayama Medical Center
-
Suita, Japão, 565-0871
- Osaka University Hospital
-
Tokyo, Japão, 162-8666
- Tokyo Women's Medical University Hospital
-
Tokyo, Japão, 113-8431
- Juntendo University Hospital
-
Tokyo, Japão, 105-8471
- The Jikei University Hospital
-
Tokyo, Japão, 177-8521
- Juntendo University Nerima Hospital, department of renal and hypertension
-
Tsukuba, Japão, 305-8576
- University of Tsukuba Hospital
-
Ube, Japão, 755-8505
- Yamaguchi University Hospital
-
-
-
-
-
Ampang, Malásia, 68000
- Hospital Ampang
-
Miri, Malásia, 98000
- Miri Hospital
-
-
FED. Territory of Kuala Lumpur
-
Kuala Lumpur, FED. Territory of Kuala Lumpur, Malásia, 50586
- Hospital Kuala Lumpur
-
Kuala Lumpur, FED. Territory of Kuala Lumpur, Malásia, 59100
- University Malaya Medical Centre
-
-
Pahang
-
Kuantan, Pahang, Malásia, 25100
- Hospital Tengku Ampuan Afzan
-
Seri Manjong, Pahang, Malásia, 32040
- Hospital Seri Manjung
-
-
Perak
-
Taiping, Perak, Malásia, 34000
- Taiping Hospital
-
-
Sarawak
-
Sibu, Sarawak, Malásia, 96000
- Hospital Sibu
-
-
-
-
Aguascalientes
-
Fracc Lomas Del Campestre, Aguascalientes, México, 20129
- Clinica San Cosme
-
-
Michoacán
-
Morelia, Michoacán, México, 58260
- Centro de Investigacion Clinica Chapultepec S. A. de C. V.
-
-
Morelos
-
Cuernavaca, Morelos, México, 62448
- Instituto Mexicano de Trasplantes
-
-
-
-
-
Krakow, Polônia, 31-559
- SCM Clinic - Prywatny Szpital Specjalistyczny
-
Lodz, Polônia, 92-213
- SPZOZ Centralny Szpital Klin
-
Opole, Polônia, 45401
- Uniwersytecki Szpital Kliniczny w Opolu
-
Poznan, Polônia, 60-355
- Uniwersytecki Szpital Kliniczny w Poznaniu - Przybyszewskiego 49
-
Warsaw, Polônia, 02-006
- Szpital Kliniczny Dzieciatka Jezus
-
-
-
-
-
Cambridge, Reino Unido, CB2 0QQ
- Addenbrookes Hospital
-
Leicester, Reino Unido, LE5 4PW
- Leicester General Hospital
-
London, Reino Unido, SE1 9RT
- Guys and St Thomas Hospital
-
London, Reino Unido, SE5 9RS
- Kings College Hospital
-
Oxford, Reino Unido, OX3 7LE
- Churchill Hospital
-
Salford, Reino Unido, M6 8HD
- Salford Royal Hospital
-
-
-
-
-
Changhua, Taiwan, 500
- Changhua Christian Hospital
-
Kaohsiung City, Taiwan, 83301
- Chang Gung Medical Foundation
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
Taipei, Taiwan, 220
- Far Eastern Memorial Hospital
-
Taoyuan City, Taiwan, 333
- Chang Gung Memorial Hospital, Linkou
-
Xitun Dist., Taiwan, 40705
- Taichung Veterans General Hospital
-
Zhongshan Dist., Taiwan, 10449
- Mackay Memorial Hospital-Taipei branch
-
-
-
-
-
Hradec Králové, Tcheca, 500 05
- Fakultni nemocnice Hradec Kralove
-
Prague, Tcheca, 12808
- Vseobecna fakultni nemocnice v Praze
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
Outros nomes:
|
|
Comparador de 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37
Prazo: Baseline, Week 37
|
UPCR will be assessed in urine sampled over 24 hours. |
Baseline, Week 37
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Porcentagem de participantes com eventos adversos emergentes do tratamento (TEAES)
Prazo: Até aproximadamente 36 meses
|
Até aproximadamente 36 meses
|
|
|
Concentração plasmática de Sefaxersen
Prazo: Até aproximadamente 36 meses
|
Até aproximadamente 36 meses
|
|
|
Percentage of Participants Achieving Hematuria Resolution at Week 37
Prazo: At Week 37
|
At Week 37
|
|
|
Estimated Glomerular Filtration Rate (eGFR) Slope at Week 105 from Baseline
Prazo: 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
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Clinical Trials, Hoffmann-La Roche
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de agosto de 2023
Conclusão Primária (Estimado)
25 de maio de 2028
Conclusão do estudo (Estimado)
31 de agosto de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
22 de março de 2023
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de março de 2023
Primeira postagem (Real)
4 de abril de 2023
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de outubro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de outubro de 2026
Última verificação
1 de outubro de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- WA43966
- 2022-502102-32-00 (Ctis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .