A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sefaxersen, an Antisense Inhibitor of Complement Factor B, in Patients With Primary IgA Nephropathy at High Risk of Progression

Status: Recruiting
Location: See all (186) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate the efficacy, safety, and 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
UAB Nephrology Research Clinic
RECRUITING
Birmingham
Arizona
Sunrise Medical Management LLC
RECRUITING
Surprise
Tucson Neuroscience Research - M3 WR
WITHDRAWN
Tucson
California
Kidney Disease Medical Group Inc-1505 Wilson Ter
RECRUITING
Glendale
Southern California Medical Research Center
WITHDRAWN
La Palma
Academic Medical Research Institute - Los Angeles
RECRUITING
Los Angeles
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica
RECRUITING
Los Angeles
North America Research Institute-San Dimas
RECRUITING
San Dimas
Florida
Hope Clinic & Research Center
WITHDRAWN
Hialeah
LCC Medical Research - Miami - ClinEdge - PPDS
RECRUITING
Miami
L&C Professional Medical Research Institute
RECRUITING
West Miami
Georgia
Cowry Medical Group LLC
RECRUITING
Acworth
Iowa
University of Iowa
RECRUITING
Iowa City
Idaho
Care Institute Idaho Kidney Institute
RECRUITING
Chubbuck
Care Institute Idaho Kidney Institute
RECRUITING
Idaho Falls
Illinois
Nephrology Associates of Northern Illinois
RECRUITING
Hinsdale
Massachusetts
Massachussets General Hospital
RECRUITING
Boston
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
North Carolina
North Carolina Nephrology, PA
RECRUITING
Raleigh
Nevada
Sierra Nevada Nephrology Consultants
RECRUITING
Reno
New York
NYU Langone Nephrology Associates - Mineola
RECRUITING
Mineola
Ohio
Ohio State University Wexner Medical Center - Outpatient Care East
RECRUITING
Columbus
Oregon
Kidney and Hypertension Center
WITHDRAWN
Roseburg
Texas
Global Medical Research - M3 WR
WITHDRAWN
Dallas
Texas Kidney Institute - Dallas
RECRUITING
Dallas
Pioneer Research Solutions
RECRUITING
Houston
Prolato Clinical Research Center
RECRUITING
Houston
R & H Clinical Research
RECRUITING
Katy
Revival Research Corporation - Sherman - ClinEdge - PPDS
RECRUITING
Sherman
Utah
Utah Kidney Research Institute
RECRUITING
Salt Lake City
Virginia
Nephrology Associates of Northern Virginia Inc
RECRUITING
Fairfax
Virginia Commonwealth University
RECRUITING
Richmond
Wisconsin
Milwaukee Nephrologists, Sc
RECRUITING
Wauwatosa
Other Locations
Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
RECRUITING
Ciudad Autonoma Buenos Aires
Consultorios Médicos Dr. Doreski
RECRUITING
Ciudad Autonoma Buenos Aires
Sanatorio Allende
RECRUITING
Córdoba
Sanatorio Mayo Privado
RECRUITING
Córdoba
Instituto Medico de la Fundacion Estudios Clinicos
RECRUITING
Rosario
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Nepean Hospital
RECRUITING
Kingswood
St George Hospital
RECRUITING
Kogarah
Liverpool Hospital
RECRUITING
Liverpool
Royal Melbourne Hospital
RECRUITING
Parkville
Sunshine Hospital
RECRUITING
St Albans
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Brazil
Freire Pesquisa Clinica
RECRUITING
Belo Horizonte
Santa Casa de Misericordia de Belo Horizonte - PPDS
RECRUITING
Belo Horizonte
Centro de Pesquisa Clinica da Fundação Pró Rim
RECRUITING
Joinville
Hospital de Clinicas de Porto Alegre HCPA PPDS
RECRUITING
Porto Alegre
Instituto D?Or Pesquisa e Ensino - Hospital Gloria D?Or
RECRUITING
Rio De Janeiro
Faculdade de Medicina da Universidade de Sao Paulo
RECRUITING
São Paulo
Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos
RECRUITING
São Paulo
Canada
London Health Sciences Centre · Victoria Hospital
RECRUITING
London
Montreal General Hospital
RECRUITING
Montreal
Centre Hospitalier Universitaire de Quebec
RECRUITING
Québec
Cape Breton Regional Hospital
RECRUITING
Sydney
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Vancouver General Hospital
RECRUITING
Vancouver
China
Beijing Friendship Hospital, Capital Medical University - PPDS
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Changzhou First People's Hospital
RECRUITING
Changzhou
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
RECRUITING
Chengdu
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Zhejiang Provincial People?s Hospital
RECRUITING
Hangzhou
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Ningbo No.2 Hospital
RECRUITING
Ningbo
Ruijin Hospital Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Shenzhen People's Hospital
RECRUITING
Shenzhen
The University of Hong Kong - Shenzhen Hospital
RECRUITING
Shenzhen
The First Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
The First Affiliated Hospital of Xian Jiao Tong University
RECRUITING
Xi'an
General Hospital of Ningxia Medical University
RECRUITING
Yinchuan
Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
France
Centre Hospitalier
RECRUITING
Annonay
CHU Boulogne sur Mer
RECRUITING
Boulogne-sur-mer
Hopital Henri Mondor
RECRUITING
Créteil
Hopital Bichat - Claude Bernard AP-HP
RECRUITING
Paris
Hopital Tenon
RECRUITING
Paris
Hôpital de Rangueil
RECRUITING
Toulouse
Germany
Universitatsklinikum der RWTH Aachen
RECRUITING
Aachen
Klinikum Koln-Merheim
RECRUITING
Cologne
Medizinische Hochschule Hannover
RECRUITING
Hanover
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
RECRUITING
Mainz
Greece
University General Hospital of Heraklion
RECRUITING
Heraklion
Venizeleio General Hospital of Heraklion
RECRUITING
Heraklion
University General Hospital of Patras
RECRUITING
Pátrai
Ippokratio General Hospital of Thessaloniki
WITHDRAWN
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hong Kong
Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
RECRUITING
Bari
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
RECRUITING
Bologna
Ospedale Policlinico San Martino
RECRUITING
Genoa
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Napoli
IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit
RECRUITING
Pavia
Fondazione Policlinico Universitario A Gemelli
RECRUITING
Rome
Ospedale San Giovanni Bosco
RECRUITING
Turin
Japan
Fujita Health University Hospital
RECRUITING
Aichi
Hirosaki University Hospital
RECRUITING
Aomori
Juntendo University Urayasu Hospital
RECRUITING
Chiba
University of Yamanashi Hospital
RECRUITING
Chūō
Matsuyama Red Cross Hospital
RECRUITING
Ehime
Japanese Red Cross Fukuoka Hospital
RECRUITING
Fukuoka
Hiroshima University Hospital
RECRUITING
Hiroshima
Hokkaido University Hospital
RECRUITING
Hokkaido
Tokyo Medical University Ibaraki Medical Center
RECRUITING
Inashiki-gun
Kanazawa Medical University Hospital
RECRUITING
Ishikawa
Nara Medical University Hospital
RECRUITING
Kashihara
Kumamoto University Hospital
RECRUITING
Kumamoto
Tohoku University Hospital
RECRUITING
Miyagi
Kyoto City Hospital
RECRUITING
Nakagyo-ku
Nara Prefecture General Medical Center
RECRUITING
Nara
Hyogo Prefectural Nishinomiya Hospital
RECRUITING
Nishinomiya
Iwate Medical University Hospital
RECRUITING
Numakunai
National Hospital Organization Okayama Medical Center
RECRUITING
Okayama
Okayama University Hospital
RECRUITING
Okayama-shi Kita-ku
University of the Ryukyus Hospital
RECRUITING
Okinawa
Saitama Medical University Hospital
RECRUITING
Saitama
Osaka University Hospital
RECRUITING
Suita
Jichi Medical University Hospital
RECRUITING
Tochigi
Tokushima University Hospital
RECRUITING
Tokushima
Juntendo University Hospital
RECRUITING
Tokyo
Juntendo University Nerima Hospital, department of renal and hypertension
RECRUITING
Tokyo
The Jikei University Hospital
RECRUITING
Tokyo
Tokyo Women's Medical University Hospital
RECRUITING
Tokyo
University of Tsukuba Hospital
RECRUITING
Tsukuba
Yamaguchi University Hospital
RECRUITING
Ube
Malaysia
Hospital Ampang
RECRUITING
Ampang
Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Hospital Tengku Ampuan Afzan
RECRUITING
Kuantan
Miri Hospital
RECRUITING
Miri
Hospital Seri Manjung
RECRUITING
Seri Manjong
Hospital Sibu
RECRUITING
Sibu
Taiping Hospital
RECRUITING
Taiping
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
RECRUITING
Barrio Belisario Domínguez Secc Xvi
Instituto Mexicano de Trasplantes
RECRUITING
Cuernavaca
Clinica San Cosme
RECRUITING
Fracc Lomas Del Campestre
Christus Latam Hub Center Of Excellence & Innovation
RECRUITING
Monterrey
Centro de Investigacion Clinica Chapultepec S. A. de C. V.
RECRUITING
Morelia
Poland
SCM Clinic - Prywatny Szpital Specjalistyczny
RECRUITING
Krakow
SPZOZ Centralny Szpital Klin
RECRUITING
Lodz
Uniwersytecki Szpital Kliniczny w Opolu
RECRUITING
Opole
Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu
RECRUITING
Późna
Szpital Kliniczny Dzieciatka Jezus
RECRUITING
Warsaw
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
RECRUITING
Wroc?aw
Republic of Korea
Hallym University Sacred Heart Hospital
RECRUITING
Anyang-si
Soon Chun Hyang University Hospital Bucheon
RECRUITING
Bucheon-si
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Ajou University Hospital
RECRUITING
Gyeonggi-do
CHA Bundang Medical Center, CHA University
RECRUITING
Seongnam-si
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Gangdong Kyung Hee University Hospital
RECRUITING
Seoul
Konkuk University Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
SMG-SNU Boramae Medical Center
RECRUITING
Seoul
Singapore
Changi General Hospital
RECRUITING
Singapore
National University Hospital
RECRUITING
Singapore
Singapore General Hospital
RECRUITING
Singapore
Tan Tock Seng Hospital
RECRUITING
Singapore
Spain
Hospital Universitario Vall d'Hebron - PPDS
RECRUITING
Barcelona
C.H. Regional Reina Sofia - PPDS
RECRUITING
Córdoba
Hospital Universitari Arnau de Vilanova
RECRUITING
Lleida
Hospital Ribera Polusa
RECRUITING
Lugo
Hospital Universitario 12 De Octubre
RECRUITING
Madrid
Hospital Universitario La Paz - PPDS
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio - PPDS
RECRUITING
Seville
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Chang Gung Medical Foundation
RECRUITING
Kaohsiung City
China Medical University Hospital
RECRUITING
Taichung
Far Eastern Memorial Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital, Linkou
RECRUITING
Taoyuan
Taichung Veterans General Hospital
RECRUITING
Xitun Dist.
Mackay Memorial Hospital-Taipei branch
RECRUITING
Zhongshan Dist.
United Kingdom
Addenbrookes Hospital
RECRUITING
Cambridge
Leicester General Hospital
RECRUITING
Leicester
Guys and St Thomas Hospital
RECRUITING
London
Kings College Hospital
RECRUITING
London
Churchill Hospital
RECRUITING
Oxford
Salford Royal Hospital
RECRUITING
Salford
Contact Information
Primary
WA43966 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2023-08-08
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 428
Treatments
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 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_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov