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一项评估 RO7434656 在原发性免疫球蛋白 A (IgA) 肾病进展高风险参与者中的疗效和安全性的研究 (IMAGINATION)

2026年10月27日更新者：Hoffmann-La Roche

一项 III 期、多中心、随机、双盲、安慰剂对照研究，以评估 RO7434656（一种补体因子 B 的反义抑制剂）在进展风险高的原发性 IgA 肾病患者中的疗效和安全性

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.

研究概览

地位

主动，不招人

条件

原发性 IgA 肾病

干预/治疗

研究类型

介入性

注册 (实际的)

459

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

中国
- - Beijing、中国、100044
    - Peking University People's Hospital
  - Beijing、中国、100034
    - Peking University First Hospital
  - Changzhou、中国、213003
    - Changzhou First People's Hospital
  - Chengdu、中国、610041
    - West China Hospital, Sichuan University
  - Chengdu、中国、610072
    - Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
  - Guangzhou、中国、510080
    - Guangdong Provincial People's Hospital
  - Hangzhou、中国、310016
    - Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
  - Hangzhou、中国、310014
    - Zhejiang Provincial People?s Hospital
  - Nanchang、中国、330000
    - The First Affiliated Hospital of Nanchang University
  - Nanjing、中国、210003
    - The Second Affiliated Hospital of Nanjing Medical University
  - Ningbo、中国、315000
    - Ningbo No.2 Hospital
  - Shanghai、中国、200025
    - Ruijin Hospital Shanghai Jiaotong University School of Medicine
  - Shanghai、中国
    - Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
  - Shenzhen、中国、518020
    - Shenzhen People's Hospital
  - Shenzhen、中国、518053
    - The University of Hong Kong - Shenzhen Hospital
  - Suzhou、中国、215004
    - The Second Affiliated Hospital of Soochow University
  - Wuhan、中国、430060
    - Renmin Hospital of Wuhan University
  - Xi'an、中国、710061
    - The First Affiliated Hospital of Xian Jiao Tong University
  - Yinchuan、中国、750004
    - General Hospital of Ningxia Medical University
  - Zhenjiang、中国、212001
    - Affiliated Hospital of Jiangsu University
- Beijing Municipality
  - Beijing、Beijing Municipality、中国、000000
    - Beijing Friendship Hospital, Capital Medical University - PPDS
- Hebei
  - Cangzhou Shi、Hebei、中国、060001
    - Cangzhou Central Hospital
  - Shijiazhuang、Hebei、中国、050031
    - The First Hospital of Hebei Medical University
- Jiangsu
  - Wuxi、Jiangsu、中国、214023
    - Wuxi People's Hospital
加拿大
- - Québec、加拿大、G1R 2J6
    - Centre Hospitalier Universitaire de Quebec
- British Columbia
  - Vancouver、British Columbia、加拿大、V5Z 1M9
    - Vancouver General Hospital
- Nova Scotia
  - Sydney、Nova Scotia、加拿大、B1P 1P3
    - Cape Breton Regional Hospital
- Ontario
  - London、Ontario、加拿大、N6A 5W9
    - London Health Sciences Centre · Victoria Hospital
  - Toronto、Ontario、加拿大、M4N 3M5
    - Sunnybrook Health Sciences Centre
- Quebec
  - Montreal、Quebec、加拿大、H3G 1A4
    - Montreal General Hospital
台湾
- - Changhua、台湾、500
    - Changhua Christian Hospital
  - Kaohsiung City、台湾、83301
    - Chang Gung Medical Foundation
  - Taichung、台湾、40447
    - China Medical University Hospital
  - Taipei、台湾、220
    - Far Eastern Memorial Hospital
  - Taoyuan City、台湾、333
    - Chang Gung Memorial Hospital, Linkou
  - Xitun Dist.、台湾、40705
    - Taichung Veterans General Hospital
  - Zhongshan Dist.、台湾、10449
    - Mackay Memorial Hospital-Taipei branch
墨西哥
- Aguascalientes
  - Fracc Lomas Del Campestre、Aguascalientes、墨西哥、20129
    - Clinica San Cosme
- Michoacán
  - Morelia、Michoacán、墨西哥、58260
    - Centro de Investigacion Clinica Chapultepec S. A. de C. V.
- Morelos
  - Cuernavaca、Morelos、墨西哥、62448
    - Instituto Mexicano de Trasplantes
巴西
- - Rio de Janeiro、巴西、22281
    - Instituto D?Or Pesquisa e Ensino - Hospital Gloria D?Or
- Minas Gerais
  - Belo Horizonte、Minas Gerais、巴西、30150-221
    - Santa Casa de Misericordia de Belo Horizonte - PPDS
  - Belo Horizonte、Minas Gerais、巴西、30150
    - Freire Pesquisa Clinica
- Rio Grande do Sul
  - Porto Alegre、Rio Grande do Sul、巴西、90035-903
    - Hospital de Clinicas de Porto Alegre HCPA PPDS
- São Paulo
  - São Paulo、São Paulo、巴西、01246
    - Faculdade de Medicina da Universidade de Sao Paulo
  - São Paulo、São Paulo、巴西、04038-002
    - Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos
希腊
- - Heraklion、希腊、71110
    - University General Hospital of Heraklion
  - Heraklion、希腊、714 09
    - Venizeleio General Hospital of Heraklion
  - Pátrai、希腊、265 04
    - University General Hospital of Patras
德国
- - Aachen、德国、52074
    - Universitatsklinikum der RWTH Aachen
  - Berlin、德国、12101
    - St. Joseph-Krankenhaus
  - Cologne、德国、51109
    - Klinikum Koln-Merheim
  - Hanover、德国、30625
    - Medizinische Hochschule Hannover
  - Mainz、德国、55101
    - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  - Stuttgart、德国、70376
    - Robert-Bosch-Krankenhaus
  - Villingen-Schwenningen、德国、78052
    - Nephrologisches Zentrum Villingen-Schwenningen
- Saxony
  - Leipzig、Saxony、德国、04103
    - Universitätsklinikum Leipzig
意大利
- Apulia
  - Bari、Apulia、意大利、70124
    - Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
- Campania
  - Naples、Campania、意大利、80131
    - Azienda Ospedaliera Universitaria Federico II
- Emilia-Romagna
  - Bologna、Emilia-Romagna、意大利、40138
    - Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
- Liguria
  - Genoa、Liguria、意大利、16132
    - Ospedale Policlinico San Martino
- Lombardy
  - Pavia、Lombardy、意大利、27100
    - IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit
- Piedmont
  - Turin、Piedmont、意大利、10154
    - Ospedale San Giovanni Bosco
捷克语
- - Hradec Králové、捷克语、500 05
    - Fakultni nemocnice Hradec Kralove
  - Prague、捷克语、12808
    - Vseobecna fakultni nemocnice v Praze
新加坡
- - Singapore、新加坡、169608
    - Singapore General Hospital
  - Singapore、新加坡、119074
    - National University Hospital
  - Singapore、新加坡、308433
    - Tan Tock Seng Hospital
  - Singapore、新加坡、529889
    - Changi General Hospital
日本
- - Aichi、日本、470-1192
    - Fujita Health University Hospital
  - Aomori、日本、036-8563
    - Hirosaki University Hospital
  - Chiba、日本、279-0021
    - Juntendo University Urayasu Hospital
  - Chūō、日本、409-3821
    - University of Yamanashi Hospital
  - Ehime、日本、790-8524
    - Matsuyama Red Cross Hospital
  - Fukuoka、日本、815-8555
    - Japanese Red Cross Fukuoka Hospital
  - Hiroshima、日本、734-8551
    - Hiroshima University Hospital
  - Hokkaido、日本、060-8648
    - Hokkaido University Hospital
  - Hyōgo、日本、663-8241
    - Hyogo Prefectural Nishinomiya General Medical Center
  - Ishikawa、日本、920-0293
    - Kanazawa Medical University Hospital
  - Kashihara、日本、634-8522
    - Nara Medical University Hospital
  - Kumamoto、日本、860-8556
    - Kumamoto University Hospital
  - Miyagi、日本、980-8574
    - Tohoku University Hospital
  - Nara、日本、630-8054
    - Nara Prefecture General Medical Center
  - Okayama、日本、701-1192
    - National Hospital Organization Okayama Medical Center
  - Suita、日本、565-0871
    - Osaka University Hospital
  - Tokyo、日本、162-8666
    - Tokyo Women's Medical University Hospital
  - Tokyo、日本、113-8431
    - Juntendo University Hospital
  - Tokyo、日本、105-8471
    - The Jikei University Hospital
  - Tokyo、日本、177-8521
    - Juntendo University Nerima Hospital, department of renal and hypertension
  - Tsukuba、日本、305-8576
    - University of Tsukuba Hospital
  - Ube、日本、755-8505
    - Yamaguchi University Hospital
法国
- - Annonay、法国、07103
    - Centre Hospitalier
  - Boulogne-sur-Mer、法国、62200
    - CHU Boulogne sur Mer
  - Paris、法国、75020
    - Hopital Tenon
  - Toulouse、法国、31059
    - Hôpital de Rangueil
波兰
- - Krakow、波兰、31-559
    - SCM Clinic - Prywatny Szpital Specjalistyczny
  - Lodz、波兰、92-213
    - SPZOZ Centralny Szpital Klin
  - Opole、波兰、45401
    - Uniwersytecki Szpital Kliniczny w Opolu
  - Poznan、波兰、60-355
    - Uniwersytecki Szpital Kliniczny w Poznaniu - Przybyszewskiego 49
  - Warsaw、波兰、02-006
    - Szpital Kliniczny Dzieciatka Jezus
澳大利亚
- New South Wales
  - Kingswood、New South Wales、澳大利亚、02747
    - Nepean Hospital
  - Kogarah、New South Wales、澳大利亚、2217
    - St George Hospital
  - Liverpool、New South Wales、澳大利亚、2170
    - Liverpool Hospital
- Queensland
  - Woolloongabba、Queensland、澳大利亚、4102
    - Princess Alexandra Hospital
- South Australia
  - Adelaide、South Australia、澳大利亚、SA5000
    - Royal Adelaide Hospital
- Victoria
  - Parkville、Victoria、澳大利亚、3050
    - Royal Melbourne Hospital
  - St Albans、Victoria、澳大利亚、3021
    - Sunshine Hospital
美国
- Alabama
  - Birmingham、Alabama、美国、35233
    - UAB Nephrology Research Clinic
- California
  - Glendale、California、美国、91206-4032
    - Kidney Disease Medical Group Inc-1505 Wilson Ter
  - Los Angeles、California、美国、90022
    - Academic Medical Research Institute - Los Angeles
  - Los Angeles、California、美国、90095-8361
    - UCLA University of California Los Angeles
  - San Dimas、California、美国、91773
    - North America Research Institute-San Dimas
- Florida
  - Orlando、Florida、美国、32806
    - Central Florida Kidney Specialists
  - West Miami、Florida、美国、33144
    - L&C Professional Medical Research Institute
- Georgia
  - Acworth、Georgia、美国、30101
    - Cowry Medical Group LLC
- Idaho
  - Idaho Falls、Idaho、美国、83402
    - Care Institute Idaho Kidney Institute
- Illinois
  - Hinsdale、Illinois、美国、60521
    - Nephrology Associates of Northern Illinois
- Massachusetts
  - Boston、Massachusetts、美国、02114
    - Massachussets General Hospital
- Nevada
  - Reno、Nevada、美国、89511
    - Sierra Nevada Nephrology Consultants
- North Carolina
  - Raleigh、North Carolina、美国、27609
    - North Carolina Nephrology, PA
- Texas
  - Dallas、Texas、美国、75231
    - Texas Kidney Institute - Dallas
  - Houston、Texas、美国、77054
    - Prolato Clinical Research Center
  - Houston、Texas、美国、077099
    - Pioneer Research Solutions
  - Katy、Texas、美国、77449
    - R & H Clinical Research
  - McKinney、Texas、美国、75071
    - Revival Research Institute - McKinney
- Virginia
  - Fairfax、Virginia、美国、22033
    - Nephrology Associates of Northern Virginia Inc
  - Richmond、Virginia、美国、23298
    - Virginia Commonwealth University
英国
- - Cambridge、英国、CB2 0QQ
    - Addenbrookes Hospital
  - Leicester、英国、LE5 4PW
    - Leicester General Hospital
  - London、英国、SE1 9RT
    - Guys and St Thomas Hospital
  - London、英国、SE5 9RS
    - Kings College Hospital
  - Oxford、英国、OX3 7LE
    - Churchill Hospital
  - Salford、英国、M6 8HD
    - Salford Royal Hospital
西班牙
- - Barcelona、西班牙、08035
    - Hospital Universitario Vall d'Hebron - PPDS
  - Madrid、西班牙、28046
    - Hospital Universitario La Paz - PPDS
  - Seville、西班牙、41013
    - Hospital Universitario Virgen del Rocio - PPDS
- Lerida
  - Lleida、Lerida、西班牙、25198
    - Hospital Universitari Arnau de Vilanova
阿根廷
- - Ciudad Autonoma Buenos Aires、阿根廷、C1425AGC
    - Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
  - Ciudad Autonoma Buenos Aires、阿根廷、C1426ABP
    - Consultorios Médicos Dr. Doreski
  - Córdoba、阿根廷、X5000JHQ
    - Sanatorio Allende
  - Córdoba、阿根廷、5000
    - Sanatorio Mayo Privado
  - Rosario、阿根廷、S2013DTC
    - Instituto Medico de la Fundacion Estudios Clinicos
韩国
- - Anyang-si、韩国、14068
    - Hallym University Sacred Heart Hospital
  - Bucheon-si、韩国、420-767
    - Soon Chun Hyang University Hospital Bucheon
  - Cheongju-si、韩国、28644
    - Chungbuk National University Hospital
  - Gyeonggi-do、韩国、443-380
    - Ajou University Hospital
  - Seongnam-si、韩国、13620
    - Seoul National University Bundang Hospital
  - Seongnam-si、韩国、13496
    - CHA Bundang Medical Center, CHA University
  - Seoul、韩国、03080
    - Seoul National University Hospital
  - Seoul、韩国、06351
    - Samsung Medical Center
  - Seoul、韩国、05030
    - Konkuk University Medical Center
  - Seoul、韩国、05278
    - Gangdong Kyung Hee University Hospital
  - Seoul、韩国、156-707
    - SMG-SNU Boramae Medical Center
香港
- - Hong Kong、香港、999077
    - Queen Mary Hospital
马来西亚
- - Ampang、马来西亚、68000
    - Hospital Ampang
  - Miri、马来西亚、98000
    - Miri Hospital
- FED. Territory of Kuala Lumpur
  - Kuala Lumpur、FED. Territory of Kuala Lumpur、马来西亚、50586
    - Hospital Kuala Lumpur
  - Kuala Lumpur、FED. Territory of Kuala Lumpur、马来西亚、59100
    - University Malaya Medical Centre
- Pahang
  - Kuantan、Pahang、马来西亚、25100
    - Hospital Tengku Ampuan Afzan
  - Seri Manjong、Pahang、马来西亚、32040
    - Hospital Seri Manjung
- Perak
  - Taiping、Perak、马来西亚、34000
    - Taiping Hospital
- Sarawak
  - Sibu、Sarawak、马来西亚、96000
    - Hospital Sibu

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：四人间

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：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.	药品：Sefaxersen (RO7434656) Sefaxersen (RO7434656) will be administered as SC injection per schedule as specified in the protocol. 其他名称：塞法克斯森
安慰剂比较：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.	药品：Placebo Matching placebo will be administered as SC injection per schedule as specified in the protocol.

参与者组/臂

干预/治疗

实验性的：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.

药品：Sefaxersen (RO7434656)

Sefaxersen (RO7434656) will be administered as SC injection per schedule as specified in the protocol.

其他名称：

塞法克斯森

安慰剂比较：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.

药品：Placebo

Matching placebo will be administered as SC injection per schedule as specified in the protocol.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37 大体时间：Baseline, Week 37	UPCR will be assessed in urine sampled over 24 hours.	Baseline, Week 37

次要结果测量

结果测量	措施说明	大体时间
患有治疗效果不良事件的参与者百分比（TEAE）大体时间：大约36个月		大约36个月
Sefaxersen的血浆浓度大体时间：大约36个月		大约36个月
Percentage of Participants Achieving Hematuria Resolution at Week 37 大体时间：At Week 37		At Week 37
Estimated Glomerular Filtration Rate (eGFR) Slope at Week 105 from Baseline 大体时间：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 大体时间：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 大体时间：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

其他结果措施

结果测量	措施说明	大体时间
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 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hoffmann-La Roche

调查人员

研究主任：Clinical Trials、Hoffmann-La Roche

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年8月8日

初级完成 (估计的)

2028年5月25日

研究完成 (估计的)

2029年8月31日

研究注册日期

首次提交

2023年3月22日

首先提交符合 QC 标准的

2023年3月22日

首次发布 (实际的)

2023年4月4日

研究记录更新

最后更新发布 (实际的)

2026年10月28日

上次提交的符合 QC 标准的更新

2026年10月27日

最后验证

2026年10月1日

一项评估 RO7434656 在原发性免疫球蛋白 A (IgA) 肾病进展高风险参与者中的疗效和安全性的研究 (IMAGINATION)

一项 III 期、多中心、随机、双盲、安慰剂对照研究，以评估 RO7434656（一种补体因子 B 的反义抑制剂）在进展风险高的原发性 IgA 肾病患者中的疗效和安全性

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

其他结果措施

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

出版物和有用的链接

一般刊物

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

药物和器械信息、研究文件

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研究美国 FDA 监管的设备产品