Phase
Condition
Glomerulonephritis
Treatment
RO7434656
Sefaxersen (RO7434656)
sefaxersen (RO7434656)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Primary IgAN, as evidenced by a kidney biopsy performed within 10 years prior to orduring 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 daysimmediately prior to screening, and without an intent to modify the dose during thestudy, except for interruptions due to illness (not greater than 7 consecutivedays), unless the potential participant is intolerant to these medications
Urine Protein-to-Creatinine Ratio (UPCR) ≥ 1 gram per gram (g/g) or urine proteinexcretion ≥ 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 Haemophilusinfluenzae according to national vaccination recommendations
Female participants of childbearing potential must use adequate contraception
Exclusion
Exclusion Criteria:
Pregnancy or breastfeeding, or intention of becoming pregnant during the study orwithin 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 creatininewithin 3 months prior to screening, or rapidly progressive glomerulonephritis in theopinion of the investigator
History of kidney transplantation
Glycated Hemoglobin (HbA1c) ≥ 6.5% or a clinical diagnosis of diabetes mellitus ofany type
Systolic blood pressure >140 millimetre of mercury (mmHg) or diastolic bloodpressure >90 mmHg from the average of two measurements performed at least 1 minuteapart during screening
Initiation of sodium-glucose cotransporter-2 (SGLT2) inhibitors within 16 weeksprior to screening or during screening
Initiation of endothelin receptor antagonists within 90 days prior to screening orduring screening
Initiation of mineralocorticoid receptor antagonists or non-dihydropyridine calciumchannel 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 5.5drug-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/dayof 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 screeningor during screening
Treatment with anti-CD20 therapy within 9 months of screening or during screening
Treatment with other systemic immunosuppressive agents within 6 months ofrandomization including, but not limited to, complement inhibitors, alkylatingagents (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 thatprecludes an individual's safe participation in and completion of the study
History of malignancy within < 5 years prior to screening, with the exception ofmalignancies 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 duringscreening, or intent to initiate during the study period
Study Design
Connect with a study center
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma Buenos Aires, C1425AGC
ArgentinaSite Not Available
Consultorios Médicos Dr. Doreski
Ciudad Autonoma Buenos Aires, C1426ABP
ArgentinaSite Not Available
Sanatorio Allende
Córdoba, X5000JHQ
ArgentinaSite Not Available
Sanatorio Mayo Privado
Córdoba, 5000
ArgentinaSite Not Available
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, S2013DTC
ArgentinaSite Not Available
Nepean Hospital
Kingswood, New South Wales 02747
AustraliaSite Not Available
St George Hospital
Kogarah, New South Wales 2217
AustraliaSite Not Available
Liverpool Hospital
Liverpool, New South Wales 2170
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide, South Australia SA5000
AustraliaSite Not Available
Royal Melbourne Hospital
Parkville, Victoria 3050
AustraliaSite Not Available
Sunshine Hospital
St Albans, Victoria 3021
AustraliaSite Not Available
Freire Pesquisa Clinica
Belo Horizonte, Minas Gerais 30150
BrazilSite Not Available
Santa Casa de Misericordia de Belo Horizonte - PPDS
Belo Horizonte, Minas Gerais 30150-221
BrazilSite Not Available
Hospital de Clinicas de Porto Alegre HCPA PPDS
Porto Alegre, Rio Grande do Sul 90035-903
BrazilSite Not Available
Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo 01246
BrazilSite Not Available
Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos
São Paulo, São Paulo 04038-002
BrazilSite Not Available
Instituto D?Or Pesquisa e Ensino - Hospital Gloria D?Or
Rio de Janeiro, 22281
BrazilSite Not Available
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9
CanadaSite Not Available
Cape Breton Regional Hospital
Sydney, Nova Scotia B1P 1P3
CanadaSite Not Available
London Health Sciences Centre · Victoria Hospital
London, Ontario N6A 5W9
CanadaSite Not Available
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaSite Not Available
Montreal General Hospital
Montreal, Quebec H3G 1A4
CanadaSite Not Available
Centre Hospitalier Universitaire de Quebec
Québec, G1R 2J6
CanadaSite Not Available
Beijing Friendship Hospital, Capital Medical University - PPDS
Beijing, Beijing Municipality 000000
ChinaSite Not Available
Cangzhou Central Hospital
Cangzhou Shi, Hebei 060001
ChinaSite Not Available
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei 050031
ChinaSite Not Available
Wuxi People's Hospital
Wuxi, Jiangsu 214023
ChinaSite Not Available
Peking University First Hospital
Beijing, 100034
ChinaSite Not Available
Peking University People's Hospital
Beijing, 100044
ChinaSite Not Available
Changzhou First People's Hospital
Changzhou, 213003
ChinaSite Not Available
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, 610072
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu, 610041
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou, 510080
ChinaSite Not Available
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, 310016
ChinaSite Not Available
Zhejiang Provincial People?s Hospital
Hangzhou, 310014
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University
Nanchang, 330000
ChinaSite Not Available
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210003
ChinaSite Not Available
Ningbo No.2 Hospital
Ningbo, 315000
ChinaSite Not Available
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200025
ChinaSite Not Available
Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
Shanghai,
ChinaSite Not Available
Shenzhen People's Hospital
Shenzhen, 518020
ChinaSite Not Available
The University of Hong Kong - Shenzhen Hospital
Shenzhen, 518053
ChinaSite Not Available
The Second Affiliated Hospital of Soochow University
Suzhou, 215004
ChinaSite Not Available
Renmin Hospital of Wuhan University
Wuhan, 430060
ChinaSite Not Available
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, 710061
ChinaSite Not Available
General Hospital of Ningxia Medical University
Yinchuan, 750004
ChinaSite Not Available
Affiliated Hospital of Jiangsu University
Zhenjiang, 212001
ChinaSite Not Available
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
CzechiaSite Not Available
Vseobecna fakultni nemocnice v Praze
Prague, 12808
CzechiaSite Not Available
Centre Hospitalier
Annonay, 07103
FranceSite Not Available
CHU Boulogne sur Mer
Boulogne-sur-Mer, 62200
FranceSite Not Available
Hopital Tenon
Paris, 75020
FranceSite Not Available
Hôpital de Rangueil
Toulouse, 31059
FranceSite Not Available
Universitätsklinikum Leipzig
Leipzig, Saxony 04103
GermanySite Not Available
Universitatsklinikum der RWTH Aachen
Aachen, 52074
GermanySite Not Available
St. Joseph-Krankenhaus
Berlin, 12101
GermanySite Not Available
Klinikum Koln-Merheim
Cologne, 51109
GermanySite Not Available
Medizinische Hochschule Hannover
Hanover, 30625
GermanySite Not Available
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55101
GermanySite Not Available
Robert-Bosch-Krankenhaus
Stuttgart, 70376
GermanySite Not Available
Nephrologisches Zentrum Villingen-Schwenningen
Villingen-Schwenningen, 78052
GermanySite Not Available
University General Hospital of Heraklion
Heraklion, 71110
GreeceSite Not Available
Venizeleio General Hospital of Heraklion
Heraklion, 714 09
GreeceSite Not Available
University General Hospital of Patras
Pátrai, 265 04
GreeceSite Not Available
Queen Mary Hospital
Hong Kong, 999077
Hong KongSite Not Available
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Apulia 70124
ItalySite Not Available
Azienda Ospedaliera Universitaria Federico II
Naples, Campania 80131
ItalySite Not Available
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
Bologna, Emilia-Romagna 40138
ItalySite Not Available
Ospedale Policlinico San Martino
Genoa, Liguria 16132
ItalySite Not Available
IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit
Pavia, Lombardy 27100
ItalySite Not Available
Ospedale San Giovanni Bosco
Turin, Piedmont 10154
ItalySite Not Available
Fujita Health University Hospital
Aichi, 470-1192
JapanSite Not Available
Hirosaki University Hospital
Aomori, 036-8563
JapanSite Not Available
Juntendo University Urayasu Hospital
Chiba, 279-0021
JapanSite Not Available
University of Yamanashi Hospital
Chūō, 409-3821
JapanSite Not Available
Matsuyama Red Cross Hospital
Ehime, 790-8524
JapanSite Not Available
Japanese Red Cross Fukuoka Hospital
Fukuoka, 815-8555
JapanSite Not Available
Hiroshima University Hospital
Hiroshima, 734-8551
JapanSite Not Available
Hokkaido University Hospital
Hokkaido, 060-8648
JapanSite Not Available
Hyogo Prefectural Nishinomiya General Medical Center
Hyōgo, 663-8241
JapanSite Not Available
Kanazawa Medical University Hospital
Ishikawa, 920-0293
JapanSite Not Available
Nara Medical University Hospital
Kashihara, 634-8522
JapanSite Not Available
Kumamoto University Hospital
Kumamoto, 860-8556
JapanSite Not Available
Tohoku University Hospital
Miyagi, 980-8574
JapanSite Not Available
Nara Prefecture General Medical Center
Nara, 630-8054
JapanSite Not Available
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
JapanSite Not Available
Osaka University Hospital
Suita, 565-0871
JapanSite Not Available
Juntendo University Hospital
Tokyo, 113-8431
JapanSite Not Available
Juntendo University Nerima Hospital, department of renal and hypertension
Tokyo, 177-8521
JapanSite Not Available
The Jikei University Hospital
Tokyo, 105-8471
JapanSite Not Available
Tokyo Women's Medical University Hospital
Tokyo, 162-8666
JapanSite Not Available
University of Tsukuba Hospital
Tsukuba, 305-8576
JapanSite Not Available
Yamaguchi University Hospital
Ube, 755-8505
JapanSite Not Available
Hospital Kuala Lumpur
Kuala Lumpur, FED. Territory of Kuala Lumpur 50586
MalaysiaSite Not Available
University Malaya Medical Centre
Kuala Lumpur, FED. Territory of Kuala Lumpur 59100
MalaysiaSite Not Available
Hospital Tengku Ampuan Afzan
Kuantan, Pahang 25100
MalaysiaSite Not Available
Hospital Seri Manjung
Seri Manjong, Pahang 32040
MalaysiaSite Not Available
Taiping Hospital
Taiping, Perak 34000
MalaysiaSite Not Available
Hospital Sibu
Sibu, Sarawak 96000
MalaysiaSite Not Available
Hospital Ampang
Ampang, 68000
MalaysiaSite Not Available
Miri Hospital
Miri, 98000
MalaysiaSite Not Available
Clinica San Cosme
Fracc Lomas Del Campestre, Aguascalientes 20129
MexicoSite Not Available
Centro de Investigacion Clinica Chapultepec S. A. de C. V.
Morelia, Michoacán 58260
MexicoSite Not Available
Instituto Mexicano de Trasplantes
Cuernavaca, Morelos 62448
MexicoSite Not Available
SCM Clinic - Prywatny Szpital Specjalistyczny
Krakow, 31-559
PolandSite Not Available
SPZOZ Centralny Szpital Klin
Lodz, 92-213
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Opolu
Opole, 45401
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Poznaniu - Przybyszewskiego 49
Poznan, 60-355
PolandSite Not Available
Szpital Kliniczny Dzieciatka Jezus
Warsaw, 02-006
PolandSite Not Available
Changi General Hospital
Singapore, 529889
SingaporeSite Not Available
National University Hospital
Singapore, 119074
SingaporeSite Not Available
Singapore General Hospital
Singapore, 169608
SingaporeSite Not Available
Tan Tock Seng Hospital
Singapore, 308433
SingaporeSite Not Available
Hallym University Sacred Heart Hospital
Anyang-si, 14068
South KoreaSite Not Available
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, 420-767
South KoreaSite Not Available
Chungbuk National University Hospital
Cheongju-si, 28644
South KoreaSite Not Available
Ajou University Hospital
Gyeonggi-do, 443-380
South KoreaSite Not Available
CHA Bundang Medical Center, CHA University
Seongnam-si, 13496
South KoreaSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, 13620
South KoreaSite Not Available
Gangdong Kyung Hee University Hospital
Seoul, 05278
South KoreaSite Not Available
Konkuk University Medical Center
Seoul, 05030
South KoreaSite Not Available
SMG-SNU Boramae Medical Center
Seoul, 156-707
South KoreaSite Not Available
Samsung Medical Center
Seoul, 06351
South KoreaSite Not Available
Seoul National University Hospital
Seoul, 03080
South KoreaSite Not Available
Hospital Universitari Arnau de Vilanova
Lleida, Lerida 25198
SpainSite Not Available
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035
SpainSite Not Available
Hospital Universitario La Paz - PPDS
Madrid, 28046
SpainSite Not Available
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013
SpainSite Not Available
Changhua Christian Hospital
Changhua, 500
TaiwanSite Not Available
Chang Gung Medical Foundation
Kaohsiung City, 83301
TaiwanSite Not Available
China Medical University Hospital
Taichung, 40447
TaiwanSite Not Available
Far Eastern Memorial Hospital
Taipei, 220
TaiwanSite Not Available
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333
TaiwanSite Not Available
Taichung Veterans General Hospital
Xitun Dist., 40705
TaiwanSite Not Available
Mackay Memorial Hospital-Taipei branch
Zhongshan Dist., 10449
TaiwanSite Not Available
Addenbrookes Hospital
Cambridge, CB2 0QQ
United KingdomSite Not Available
Leicester General Hospital
Leicester, LE5 4PW
United KingdomSite Not Available
Guys and St Thomas Hospital
London, SE1 9RT
United KingdomSite Not Available
Kings College Hospital
London, SE5 9RS
United KingdomSite Not Available
Churchill Hospital
Oxford, OX3 7LE
United KingdomSite Not Available
Salford Royal Hospital
Salford, M6 8HD
United KingdomSite Not Available
UAB Nephrology Research Clinic
Birmingham, Alabama 35233
United StatesSite Not Available
Kidney Disease Medical Group Inc-1505 Wilson Ter
Glendale, California 91206-4032
United StatesSite Not Available
Academic Medical Research Institute - Los Angeles
Los Angeles, California 90022
United StatesSite Not Available
UCLA University of California Los Angeles
Los Angeles, California 90095-8361
United StatesSite Not Available
North America Research Institute-San Dimas
San Dimas, California 91773
United StatesSite Not Available
Central Florida Kidney Specialists
Orlando, Florida 32806
United StatesSite Not Available
L&C Professional Medical Research Institute
West Miami, Florida 33144
United StatesSite Not Available
Cowry Medical Group LLC
Acworth, Georgia 30101
United StatesSite Not Available
Care Institute Idaho Kidney Institute
Idaho Falls, Idaho 83402
United StatesSite Not Available
Nephrology Associates of Northern Illinois
Hinsdale, Illinois 60521
United StatesSite Not Available
Massachussets General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Sierra Nevada Nephrology Consultants
Reno, Nevada 89511
United StatesSite Not Available
North Carolina Nephrology, PA
Raleigh, North Carolina 27609
United StatesSite Not Available
Texas Kidney Institute - Dallas
Dallas, Texas 75231
United StatesSite Not Available
Pioneer Research Solutions
Houston, Texas 077099
United StatesSite Not Available
Prolato Clinical Research Center
Houston, Texas 77054
United StatesSite Not Available
R & H Clinical Research
Katy, Texas 77449
United StatesSite Not Available
Revival Research Institute - McKinney
McKinney, Texas 75071
United StatesSite Not Available
Nephrology Associates of Northern Virginia Inc
Fairfax, Virginia 22033
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23298
United StatesSite Not Available

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