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RECRUITING
NCT05797610
PHASE3

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

428

Start Date

2023-08-08

Completion Date

2029-03-31

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Sefaxersen (RO7434656)

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

DRUG

Placebo

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

Locations (200)

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 Institute - McKinney

McKinney, 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

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

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

Robert-Bosch-Krankenhaus

Stuttgart, 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

Naples, 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

4. Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

Wroclaw, Lower Silesian Voivodeship, Poland

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