Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

En studie for å evaluere effektiviteten og sikkerheten til RO7434656 hos deltakere med primær immunglobulin A (IgA) nefropati med høy risiko for progresjon (IMAGINATION)

27. oktober 2026 oppdatert av: Hoffmann-La Roche

En fase III, multisenter, randomisert, dobbeltblind, placebokontrollert studie for å evaluere effektiviteten og sikkerheten til RO7434656, en antisensehemmer av komplementfaktor B, hos pasienter med primær IgA nefropati med høy risiko for progresjon

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

459

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Sefaxersen (RO7434656)

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

Andre navn:
  • Sefaxersen
Placebo komparator: 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.
Legemiddel: Placebo

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37
Tidsramme: Baseline, Week 37

UPCR will be assessed in urine sampled over 24 hours.
Baseline, Week 37

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prosentandel av deltakerne med bivirkninger av behandlingsoppførende (TEAES)
Tidsramme: Opptil 36 måneder
Opptil 36 måneder
Plasmakonsentrasjon av Sefaxersen
Tidsramme: Opptil 36 måneder
Opptil 36 måneder
Percentage of Participants Achieving Hematuria Resolution at Week 37
Tidsramme: At Week 37
At Week 37
Estimated Glomerular Filtration Rate (eGFR) Slope at Week 105 from Baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hoffmann-La Roche

Etterforskere

  • Studieleder: Clinical Trials, Hoffmann-La Roche

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. august 2023

Primær fullføring (Antatt)

25. mai 2028

Studiet fullført (Antatt)

31. august 2029

Datoer for studieregistrering

Først innsendt

22. mars 2023

Først innsendt som oppfylte QC-kriteriene

22. mars 2023

Først lagt ut (Faktiske)

4. april 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • WA43966
  • 2022-502102-32-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere