Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT 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, \& 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

459

Start Date

2023-08-08

Completion Date

2029-08-31

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Primary IgA Nephropathy

Interventions

DRUG

Sefaxersen (RO7434656)

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

DRUG

Placebo

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

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

Locations (162)

UAB Nephrology Research Clinic

Birmingham, Alabama, United States

Kidney Disease Medical Group Inc-1505 Wilson Ter

Glendale, California, United States

Academic Medical Research Institute - Los Angeles

Los Angeles, California, United States

UCLA University of California Los Angeles

Los Angeles, California, United States

North America Research Institute-San Dimas

San Dimas, California, 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

Idaho Falls, Idaho, United States

Nephrology Associates of Northern Illinois

Hinsdale, Illinois, United States

Massachussets General Hospital

Boston, Massachusetts, United States

Sierra Nevada Nephrology Consultants

Reno, Nevada, United States

North Carolina Nephrology, PA

Raleigh, North Carolina, 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

Nephrology Associates of Northern Virginia Inc

Fairfax, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, 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

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 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 Tenon

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

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

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

And 62 more locations on ClinicalTrials.gov