A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
Start Date
8/8/2023
Completion Date
3/31/2029
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 Criteria
Age Range: 18 years to No maximum
Interventions
Sefaxersen (RO7434656)
Placebo
Conditions
Locations
Alabama Kidney Research - ERN - PPDS
Alabaster, Alabama 35007-8823
United States
UAB Nephrology Research Clinic
Birmingham, Alabama 35233
United States
Sunrise Medical Management LLC
Surprise, Arizona 85374-8644
United States
Tucson Neuroscience Research - M3 WR
Tucson, Arizona 85710
United States
Kidney Disease Medical Group Inc-1505 Wilson Ter
Glendale, California 91206-4032
United States
Southern California Medical Research Center
La Palma, California 90623
United States
Academic Medical Research Institute - Los Angeles
Los Angeles, California 90022
United States
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica
Los Angeles, California 90025-4837
United States
Los Angeles County Nephrology
Montebello, California 90640-2217
United States
North America Research Institute-San Dimas
San Dimas, California 91773
United States
Kaiser Permanente Skyport Medical Offices
San Jose, California 95110
United States
BioResearch Partner ? Jackson West
Doral, Florida 33122
United States
Hope Clinic & Research Center
Hialeah, Florida 33010
United States
LCC Medical Research - Miami - ClinEdge - PPDS
Miami, Florida 33126
United States
Central Florida Kidney Specialists
Orlando, Florida 32806
United States
L&C Professional Medical Research Institute
West Miami, Florida 33144
United States
Cowry Medical Group LLC
Acworth, Georgia 30101
United States
Care Institute Idaho Kidney Institute
Chubbuck, Idaho 83202
United States
Care Institute Idaho Kidney Institute
Idaho Falls, Idaho 83402
United States
Nephrology Associates of Northern Illinois
Hinsdale, Illinois 60521
United States
University of Iowa
Iowa City, Iowa 52242
United States
Massachussets General Hospital
Boston, Massachusetts 02114
United States
University of Mississippi Medical Center
Jackson, Mississippi 39216
United States
Sierra Nevada Nephrology Consultants
Reno, Nevada 89511
United States
NYU Langone Nephrology Associates - Mineola
Mineola, New York 11501
United States
North Carolina Nephrology, PA
Raleigh, North Carolina 27609
United States
Cleveland Clinic-9500 Euclid Ave
Cleveland, Ohio 44195-0001
United States
Ohio State University Wexner Medical Center - Outpatient Care East
Columbus, Ohio 43203
United States
Kidney and Hypertension Center
Roseburg, Oregon 97471
United States
Austin Diagnostic Clinic - Frenova F1
Austin, Texas 78751-3014
United States
Global Medical Research - M3 WR
Dallas, Texas 75224
United States
Texas Kidney Institute - Dallas
Dallas, Texas 75231
United States
Pioneer Research Solutions
Houston, Texas 077099
United States
Prolato Clinical Research Center
Houston, Texas 77054
United States
R & H Clinical Research
Katy, Texas 77449
United States
Revival Research Institute - McKinney
McKinney, Texas 75071
United States
Utah Kidney Research Institute
Salt Lake City, Utah 84115
United States
Nephrology Associates of Northern Virginia Inc
Fairfax, Virginia 22033
United States
Virginia Commonwealth University
Richmond, Virginia 23298
United States
Milwaukee Nephrologists, Sc
Wauwatosa, Wisconsin 53226
United States
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma Buenos Aires, C1425AGC
Argentina
Consultorios Médicos Dr. Doreski
Ciudad Autonoma Buenos Aires, C1426ABP
Argentina
Sanatorio Mayo Privado
Córdoba, 5000
Argentina
Sanatorio Allende
Córdoba, X5000JHQ
Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, S2013DTC
Argentina
Nepean Hospital
Kingswood, New South Wales 02747
Australia
St George Hospital
Kogarah, New South Wales 2217
Australia
Liverpool Hospital
Liverpool, New South Wales 2170
Australia
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
Australia
Royal Adelaide Hospital
Adelaide, South Australia SA5000
Australia
Royal Melbourne Hospital
Parkville, Victoria 3050
Australia
Sunshine Hospital
St Albans, Victoria 3021
Australia
Santa Casa de Misericordia de Belo Horizonte - PPDS
Belo Horizonte, Minas Gerais 30150-221
Brazil
Freire Pesquisa Clinica
Belo Horizonte, Minas Gerais 30150
Brazil
Hospital de Clinicas de Porto Alegre HCPA PPDS
Porto Alegre, Rio Grande do Sul 90035-903
Brazil
Centro de Pesquisa Clinica da Fundação Pró Rim
Joinville, Santa Catarina 89227-680
Brazil
Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo 01246
Brazil
Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos
São Paulo, São Paulo 04038-002
Brazil
Instituto D?Or Pesquisa e Ensino - Hospital Gloria D?Or
Rio de Janeiro, 22281
Brazil
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9
Canada
Cape Breton Regional Hospital
Sydney, Nova Scotia B1P 1P3
Canada
London Health Sciences Centre · Victoria Hospital
London, Ontario N6A 5W9
Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
Canada
Montreal General Hospital
Montreal, Quebec H3G 1A4
Canada
Centre Hospitalier Universitaire de Quebec
Québec, G1R 2J6
Canada
Beijing Friendship Hospital, Capital Medical University - PPDS
Beijing, Beijing Municipality 000000
China
Cangzhou Central Hospital
Cangzhou Shi, Hebei 060001
China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei 050031
China
Wuxi People's Hospital
Wuxi, Jiangsu 214023
China
Peking University First Hospital
Beijing, 100034
China
Peking University People's Hospital
Beijing, 100044
China
Changzhou First People's Hospital
Changzhou, 213003
China
West China Hospital, Sichuan University
Chengdu, 610041
China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, 610072
China
Guangdong Provincial People's Hospital
Guangzhou, 510080
China
Zhejiang Provincial People?s Hospital
Hangzhou, 310014
China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, 310016
China
The First Affiliated Hospital of Nanchang University
Nanchang, 330000
China
The Second Affiliated Hospital of Nanchang University
Nanchang, 330008
China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210003
China
Ningbo No.2 Hospital
Ningbo, 315000
China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200025
China
Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
Shanghai,
China
Shenzhen People's Hospital
Shenzhen, 518020
China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, 518053
China
The Second Affiliated Hospital of Soochow University
Suzhou, 215004
China
Renmin Hospital of Wuhan University
Wuhan, 430060
China
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, 710061
China
General Hospital of Ningxia Medical University
Yinchuan, 750004
China
Affiliated Hospital of Jiangsu University
Zhenjiang, 212001
China
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 12808
Czechia
Centre Hospitalier
Annonay, 07103
France
CHU Boulogne sur Mer
Boulogne-sur-Mer, 62200
France
Hopital Henri Mondor
Créteil, 94000
France
Hopital Tenon
Paris, 75020
France
Hopital Bichat - Claude Bernard AP-HP
Paris, 75877
France
Hôpital de Rangueil
Toulouse, 31059
France
Universitätsklinikum Leipzig
Leipzig, Saxony 04103
Germany
Universitatsklinikum der RWTH Aachen
Aachen, 52074
Germany
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, 10117
Germany
St. Joseph-Krankenhaus
Berlin, 12101
Germany
Klinikum Koln-Merheim
Cologne, 51109
Germany
Medizinische Hochschule Hannover
Hanover, 30625
Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55101
Germany
Robert-Bosch-Krankenhaus
Stuttgart, 70376
Germany
Nephrologisches Zentrum Villingen-Schwenningen
Villingen-Schwenningen, 78052
Germany
University General Hospital of Heraklion
Heraklion, 71110
Greece
Venizeleio General Hospital of Heraklion
Heraklion, 714 09
Greece
University General Hospital of Patras
Pátrai, 265 04
Greece
Ippokratio General Hospital of Thessaloniki
Thessaloniki, 546 42
Greece
Queen Mary Hospital
Hong Kong, 999077
Hong Kong
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Apulia 70124
Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Campania 80131
Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
Bologna, Emilia-Romagna 40138
Italy
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio 00168
Italy
Ospedale Policlinico San Martino
Genoa, Liguria 16132
Italy
IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit
Pavia, Lombardy 27100
Italy
Ospedale San Giovanni Bosco
Turin, Piedmont 10154
Italy
Fujita Health University Hospital
Aichi, 470-1192
Japan
Hirosaki University Hospital
Aomori, 036-8563
Japan
Juntendo University Urayasu Hospital
Chiba, 279-0021
Japan
University of Yamanashi Hospital
Chūō, 409-3821
Japan
Matsuyama Red Cross Hospital
Ehime, 790-8524
Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, 815-8555
Japan
Hiroshima University Hospital
Hiroshima, 734-8551
Japan
Hokkaido University Hospital
Hokkaido, 060-8648
Japan
Tokyo Medical University Ibaraki Medical Center
Inashiki-Gun, 300-0395
Japan
Kanazawa Medical University Hospital
Ishikawa, 920-0293
Japan
Nara Medical University Hospital
Kashihara, 634-8522
Japan
Kumamoto University Hospital
Kumamoto, 860-8556
Japan
Tohoku University Hospital
Miyagi, 980-8574
Japan
Kyoto City Hospital
Nakagyo-ku, 604-8845
Japan
Nara Prefecture General Medical Center
Nara, 630-8054
Japan
Hyogo Prefectural Nishinomiya Hospital
Nishinomiya, 662-0918
Japan
Iwate Medical University Hospital
Numakunai, 028-3695
Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
Japan
Okayama University Hospital
Okayama-Shi Kita-Ku, 700-0914
Japan
University of the Ryukyus Hospital
Okinawa, 903-0125
Japan
Saitama Medical University Hospital
Saitama, 350-0451
Japan
Osaka University Hospital
Suita, 565-0871
Japan
Jichi Medical University Hospital
Tochigi, 329-0498
Japan
Tokushima University Hospital
Tokushima, 770-8503
Japan
The Jikei University Hospital
Tokyo, 105-8471
Japan
Juntendo University Hospital
Tokyo, 113-8431
Japan
Tokyo Women's Medical University Hospital
Tokyo, 162-8666
Japan
Juntendo University Nerima Hospital, department of renal and hypertension
Tokyo, 177-8521
Japan
University of Tsukuba Hospital
Tsukuba, 305-8576
Japan
Yamaguchi University Hospital
Ube, 755-8505
Japan
Hospital Kuala Lumpur
Kuala Lumpur, FED. Territory of Kuala Lumpur 50586
Malaysia
University Malaya Medical Centre
Kuala Lumpur, FED. Territory of Kuala Lumpur 59100
Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang 25100
Malaysia
Hospital Seri Manjung
Seri Manjong, Pahang 32040
Malaysia
Taiping Hospital
Taiping, Perak 34000
Malaysia
Hospital Sibu
Sibu, Sarawak 96000
Malaysia
Hospital Ampang
Ampang, 68000
Malaysia
Miri Hospital
Miri, 98000
Malaysia
Clinica San Cosme
Fracc Lomas Del Campestre, Aguascalientes 20129
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Barrio Belisario Domínguez Secc XVI, Mexico CITY (federal District) 14080
Mexico
Centro de Investigacion Clinica Chapultepec S. A. de C. V.
Morelia, Michoacán 58260
Mexico
Instituto Mexicano de Trasplantes
Cuernavaca, Morelos 62448
Mexico
Christus Latam Hub Center Of Excellence & Innovation
Monterrey, Nuevo León 64000
Mexico
4. Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
Wroclaw, Lower Silesian Voivodeship 53-114
Poland
SCM Clinic - Prywatny Szpital Specjalistyczny
Krakow, 31-559
Poland
SPZOZ Centralny Szpital Klin
Lodz, 92-213
Poland
Uniwersytecki Szpital Kliniczny w Opolu
Opole, 45401
Poland
Uniwersytecki Szpital Kliniczny w Poznaniu - Przybyszewskiego 49
Poznan, 60-355
Poland
Szpital Kliniczny Dzieciatka Jezus
Warsaw, 02-006
Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroc?aw, 50-556
Poland
National University Hospital
Singapore, 119074
Singapore
Singapore General Hospital
Singapore, 169608
Singapore
Tan Tock Seng Hospital
Singapore, 308433
Singapore
Changi General Hospital
Singapore, 529889
Singapore
Hallym University Sacred Heart Hospital
Anyang-si, 14068
South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, 420-767
South Korea
Chungbuk National University Hospital
Cheongju-si, 28644
South Korea
Ajou University Hospital
Gyeonggi-do, 443-380
South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, 13496
South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Konkuk University Medical Center
Seoul, 05030
South Korea
Gangdong Kyung Hee University Hospital
Seoul, 05278
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
SMG-SNU Boramae Medical Center
Seoul, 156-707
South Korea
Hospital Universitari Arnau de Vilanova
Lleida, Lerida 25198
Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035
Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, 14004
Spain
Hospital Ribera Polusa
Lugo, 27004
Spain
Hospital Universitario 12 De Octubre
Madrid, 28041
Spain
Hospital Universitario La Paz - PPDS
Madrid, 28046
Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013
Spain
Changhua Christian Hospital
Changhua, 500
Taiwan
Chang Gung Medical Foundation
Kaohsiung City, 83301
Taiwan
China Medical University Hospital
Taichung, 40447
Taiwan
Far Eastern Memorial Hospital
Taipei, 220
Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333
Taiwan
Taichung Veterans General Hospital
Xitun Dist., 40705
Taiwan
Mackay Memorial Hospital-Taipei branch
Zhongshan Dist., 10449
Taiwan
Addenbrookes Hospital
Cambridge, CB2 0QQ
United Kingdom
Leicester General Hospital
Leicester, LE5 4PW
United Kingdom
Guys and St Thomas Hospital
London, SE1 9RT
United Kingdom
Kings College Hospital
London, SE5 9RS
United Kingdom
Churchill Hospital
Oxford, OX3 7LE
United Kingdom
Salford Royal Hospital
Salford, M6 8HD
United Kingdom