A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
NCT ID: NCT05797610
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
428 participants
INTERVENTIONAL
2023-08-08
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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 until up to 1 year after the common-close timepoint, the date when the last participant completes the Week 105 assessment, withdraws, or is discontinued from the study.
Sefaxersen (RO7434656)
Sefaxersen (RO7434656) will be administered as SC injection per schedule as specified.
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 until up to 1 year after the common-close timepoint, the date when the last participant completes the Week 105 assessment, withdraws, or is discontinued from the study.
Placebo
Matching placebo will be administered as SC injection per schedule as specified.
Interventions
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Sefaxersen (RO7434656)
Sefaxersen (RO7434656) will be administered as SC injection per schedule as specified.
Placebo
Matching placebo will be administered as SC injection per schedule as specified.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Alabama Kidney Research - ERN - PPDS
Alabaster, Alabama, United States
UAB Nephrology Research Clinic
Birmingham, Alabama, United States
Sunrise Medical Management LLC
Surprise, Arizona, United States
Tucson Neuroscience Research - M3 WR
Tucson, Arizona, United States
Kidney Disease Medical Group Inc-1505 Wilson Ter
Glendale, California, United States
Southern California Medical Research Center
La Palma, California, United States
Academic Medical Research Institute - Los Angeles
Los Angeles, California, United States
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica
Los Angeles, California, United States
Los Angeles County Nephrology
Montebello, California, United States
North America Research Institute-San Dimas
San Dimas, California, United States
Hope Clinic & Research Center
Hialeah, Florida, United States
LCC Medical Research - Miami - ClinEdge - PPDS
Miami, Florida, United States
Central Florida Kidney Specialists
Orlando, Florida, United States
L&C Professional Medical Research Institute
West Miami, Florida, United States
Cowry Medical Group LLC
Acworth, Georgia, United States
Care Institute Idaho Kidney Institute
Chubbuck, Idaho, United States
Care Institute Idaho Kidney Institute
Idaho Falls, Idaho, United States
Nephrology Associates of Northern Illinois
Hinsdale, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Massachussets General Hospital
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Sierra Nevada Nephrology Consultants
Reno, Nevada, United States
NYU Langone Nephrology Associates - Mineola
Mineola, New York, United States
North Carolina Nephrology, PA
Raleigh, North Carolina, United States
Ohio State University Wexner Medical Center - Outpatient Care East
Columbus, Ohio, United States
Kidney and Hypertension Center
Roseburg, Oregon, United States
Austin Diagnostic Clinic - Frenova F1
Austin, Texas, United States
Global Medical Research - M3 WR
Dallas, Texas, United States
Texas Kidney Institute - Dallas
Dallas, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
R & H Clinical Research
Katy, Texas, United States
Revival Research Corporation - Sherman - ClinEdge - PPDS
Sherman, Texas, United States
Utah Kidney Research Institute
Salt Lake City, Utah, United States
Nephrology Associates of Northern Virginia Inc
Fairfax, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Milwaukee Nephrologists, Sc
Wauwatosa, Wisconsin, United States
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma Buenos Aires, , Argentina
Consultorios Médicos Dr. Doreski
Ciudad Autonoma Buenos Aires, , Argentina
Sanatorio Mayo Privado
Córdoba, , Argentina
Sanatorio Allende
Córdoba, , Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, , Argentina
Nepean Hospital
Kingswood, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Santa Casa de Misericordia de Belo Horizonte - PPDS
Belo Horizonte, Minas Gerais, Brazil
Freire Pesquisa Clinica
Belo Horizonte, Minas Gerais, Brazil
Hospital de Clinicas de Porto Alegre HCPA PPDS
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisa Clinica da Fundação Pró Rim
Joinville, Santa Catarina, Brazil
Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, Brazil
Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos
São Paulo, São Paulo, Brazil
Instituto D?Or Pesquisa e Ensino - Hospital Gloria D?Or
Rio de Janeiro, , Brazil
Vancouver General Hospital
Vancouver, British Columbia, Canada
Cape Breton Regional Hospital
Sydney, Nova Scotia, Canada
London Health Sciences Centre · Victoria Hospital
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, , Canada
Beijing Friendship Hospital, Capital Medical University - PPDS
Beijing, Beijing Municipality, China
Cangzhou Central Hospital
Cangzhou Shi, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Peking University First Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Changzhou First People's Hospital
Changzhou, , China
West China Hospital, Sichuan University
Chengdu, , China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Zhejiang Provincial People?s Hospital
Hangzhou, , China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, , China
Ningbo No.2 Hospital
Ningbo, , China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, , China
Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
Shanghai, , China
Shenzhen People's Hospital
Shenzhen, , China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, , China
The Second Affiliated Hospital of Soochow University
Suzhou, , China
Renmin Hospital of Wuhan University
Wuhan, , China
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, , China
General Hospital of Ningxia Medical University
Yinchuan, , China
Affiliated Hospital of Jiangsu University
Zhenjiang, , China
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Centre Hospitalier
Annonay, , France
CHU Boulogne sur Mer
Boulogne-sur-Mer, , France
Hopital Henri Mondor
Créteil, , France
Hopital Tenon
Paris, , France
Hopital Bichat - Claude Bernard AP-HP
Paris, , France
Hôpital de Rangueil
Toulouse, , France
Universitatsklinikum der RWTH Aachen
Aachen, , Germany
St. Joseph-Krankenhaus
Berlin, , Germany
Klinikum Koln-Merheim
Cologne, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Nephrologisches Zentrum Villingen-Schwenningen
Villingen-Schwenningen, , Germany
University General Hospital of Heraklion
Heraklion, , Greece
Venizeleio General Hospital of Heraklion
Heraklion, , Greece
University General Hospital of Patras
Pátrai, , Greece
Ippokratio General Hospital of Thessaloniki
Thessaloniki, , Greece
Queen Mary Hospital
Hong Kong, , Hong Kong
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Apulia, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
Bologna, Emilia-Romagna, Italy
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, Italy
Ospedale Policlinico San Martino
Genoa, Liguria, Italy
IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit
Pavia, Lombardy, Italy
Ospedale San Giovanni Bosco
Turin, Piedmont, Italy
Fujita Health University Hospital
Aichi, , Japan
Hirosaki University Hospital
Aomori, , Japan
Juntendo University Urayasu Hospital
Chiba, , Japan
University of Yamanashi Hospital
Chūō, , Japan
Matsuyama Red Cross Hospital
Ehime, , Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
Tokyo Medical University Ibaraki Medical Center
Inashiki-Gun, , Japan
Kanazawa Medical University Hospital
Ishikawa, , Japan
Nara Medical University Hospital
Kashihara, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Tohoku University Hospital
Miyagi, , Japan
Kyoto City Hospital
Nakagyo-ku, , Japan
Nara Prefecture General Medical Center
Nara, , Japan
Hyogo Prefectural Nishinomiya Hospital
Nishinomiya, , Japan
Iwate Medical University Hospital
Numakunai, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Okayama University Hospital
Okayama-Shi Kita-Ku, , Japan
University of the Ryukyus Hospital
Okinawa, , Japan
Saitama Medical University Hospital
Saitama, , Japan
Osaka University Hospital
Suita, , Japan
Jichi Medical University Hospital
Tochigi, , Japan
Tokushima University Hospital
Tokushima, , Japan
The Jikei University Hospital
Tokyo, , Japan
Juntendo University Hospital
Tokyo, , Japan
Tokyo Women's Medical University Hospital
Tokyo, , Japan
Juntendo University Nerima Hospital, department of renal and hypertension
Tokyo, , Japan
University of Tsukuba Hospital
Tsukuba, , Japan
Yamaguchi University Hospital
Ube, , Japan
Hospital Kuala Lumpur
Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
Hospital Seri Manjung
Seri Manjong, Pahang, Malaysia
Taiping Hospital
Taiping, Perak, Malaysia
Hospital Sibu
Sibu, Sarawak, Malaysia
Hospital Ampang
Ampang, , Malaysia
Miri Hospital
Miri, , Malaysia
Clinica San Cosme
Fracc Lomas Del Campestre, Aguascalientes, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Barrio Belisario Domínguez Secc XVI, Mexico CITY (federal District), Mexico
Centro de Investigacion Clinica Chapultepec S. A. de C. V.
Morelia, Michoacán, Mexico
Instituto Mexicano de Trasplantes
Cuernavaca, Morelos, Mexico
Christus Latam Hub Center Of Excellence & Innovation
Monterrey, Nuevo León, Mexico
SCM Clinic - Prywatny Szpital Specjalistyczny
Krakow, , Poland
SPZOZ Centralny Szpital Klin
Lodz, , Poland
Uniwersytecki Szpital Kliniczny w Opolu
Opole, , Poland
Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu
Późna, , Poland
Szpital Kliniczny Dzieciatka Jezus
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroc?aw, , Poland
National University Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Changi General Hospital
Singapore, , Singapore
Hallym University Sacred Heart Hospital
Anyang-si, , South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, , South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Ajou University Hospital
Gyeonggi-do, , South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Gangdong Kyung Hee University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Hospital Universitari Arnau de Vilanova
Lleida, Lerida, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, , Spain
Hospital Ribera Polusa
Lugo, , Spain
Hospital Universitario 12 De Octubre
Madrid, , Spain
Hospital Universitario La Paz - PPDS
Madrid, , Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
Chang Gung Medical Foundation
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Far Eastern Memorial Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, , Taiwan
Taichung Veterans General Hospital
Xitun Dist., , Taiwan
Mackay Memorial Hospital-Taipei branch
Zhongshan Dist., , Taiwan
Addenbrookes Hospital
Cambridge, , United Kingdom
Leicester General Hospital
Leicester, , United Kingdom
Guys and St Thomas Hospital
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Countries
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Central Contacts
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WA43966 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. Only)
Email: [email protected]
References
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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.
Other Identifiers
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WA43966
Identifier Type: -
Identifier Source: org_study_id
2022-502102-32-00
Identifier Type: CTIS
Identifier Source: secondary_id