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NCT05797610PHASE3Recruiting

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

Hoffmann-La Roche

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

Inclusion Criteria: * 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 Exclusion Criteria: * Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 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 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 millimetre of mercury (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

Interventions

DRUG

Sefaxersen (RO7434656)

DRUG

Placebo

Interested in This Trial?

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Conditions

Primary IgA Nephropathy

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