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New drug aims to slow kidney failure in IgA nephropathy patients

NCT ID NCT05797610

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This phase 3 trial tests sefaxersen, a drug that targets a part of the immune system, in 428 people with IgA nephropathy at high risk of kidney decline. Participants receive either sefaxersen or a placebo as a shot under the skin. The main goal is to see if the drug reduces protein in the urine, a sign of kidney damage, over 37 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sefaxersen
What this could lead to
If it works, this could slow kidney damage and delay the need for dialysis or transplant in people with IgA nephropathy.
What could go wrong
This is a phase 3 trial, but results are not guaranteed. The drug may not work better than placebo, and side effects from the injection or immune suppression are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

459 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

IgA glomerulonephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary IgA nephropathy

Contacts and locations

Locations

  • 4. Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

    Wroclaw, Lower Silesian Voivodeship, 53-114, Poland

  • Academic Medical Research Institute - Los Angeles

    Los Angeles, California, 90022, United States

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, 212001, China

  • Ajou University Hospital

    Gyeonggi-do, 443-380, South Korea

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Campania, 80131, Italy

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    Bari, Apulia, 70124, Italy

  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti

    Bologna, Emilia-Romagna, 40138, Italy

  • Beijing Friendship Hospital, Capital Medical University - PPDS

    Beijing, Beijing Municipality, 000000, China

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, 14004, Spain

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, 13496, South Korea

  • CHU Boulogne sur Mer

    Boulogne-sur-Mer, 62200, France

  • Cangzhou Central Hospital

    Cangzhou Shi, Hebei, 060001, China

  • Cape Breton Regional Hospital

    Sydney, Nova Scotia, B1P 1P3, Canada

  • Care Institute Idaho Kidney Institute

    Idaho Falls, Idaho, 83402, United States

  • Central Florida Kidney Specialists

    Orlando, Florida, 32806, United States

  • Centre Hospitalier

    Annonay, 07103, France

  • Centre Hospitalier Universitaire de Quebec

    Québec, G1R 2J6, Canada

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Ciudad Autonoma Buenos Aires, C1425AGC, Argentina

  • Centro de Investigacion Clinica Chapultepec S. A. de C. V.

    Morelia, Michoacán, 58260, Mexico

  • Chang Gung Medical Foundation

    Kaohsiung City, 83301, Taiwan

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 333, Taiwan

  • Changhua Christian Hospital

    Changhua, 500, Taiwan

  • Changi General Hospital

    Singapore, 529889, Singapore

  • Changzhou First People's Hospital

    Changzhou, 213003, China

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin, 10117, Germany

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • Churchill Hospital

    Oxford, OX3 7LE, United Kingdom

  • Clinica San Cosme

    Fracc Lomas Del Campestre, Aguascalientes, 20129, Mexico

  • Consultorios Médicos Dr. Doreski

    Ciudad Autonoma Buenos Aires, C1426ABP, Argentina

  • Cowry Medical Group LLC

    Acworth, Georgia, 30101, United States

  • Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo, São Paulo, 01246, Brazil

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Far Eastern Memorial Hospital

    Taipei, 220, Taiwan

  • Fondazione Policlinico Universitario A Gemelli

    Rome, Lazio, 00168, Italy

  • Freire Pesquisa Clinica

    Belo Horizonte, Minas Gerais, 30150, Brazil

  • Fujita Health University Hospital

    Aichi, 470-1192, Japan

  • Gangdong Kyung Hee University Hospital

    Seoul, 05278, South Korea

  • General Hospital of Ningxia Medical University

    Yinchuan, 750004, China

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080, China

  • Guys and St Thomas Hospital

    London, SE1 9RT, United Kingdom

  • Hallym University Sacred Heart Hospital

    Anyang-si, 14068, South Korea

  • Hirosaki University Hospital

    Aomori, 036-8563, Japan

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • Hokkaido University Hospital

    Hokkaido, 060-8648, Japan

  • Hopital Bichat - Claude Bernard AP-HP

    Paris, 75877, France

  • Hopital Henri Mondor

    Créteil, 94000, France

  • Hopital Tenon

    Paris, 75020, France

  • Hospital Ampang

    Ampang, 68000, Malaysia

  • Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos

    São Paulo, São Paulo, 04038-002, Brazil

  • Hospital Kuala Lumpur

    Kuala Lumpur, FED. Territory of Kuala Lumpur, 50586, Malaysia

  • Hospital Ribera Polusa

    Lugo, 27004, Spain

  • Hospital Seri Manjung

    Seri Manjong, Pahang, 32040, Malaysia

  • Hospital Sibu

    Sibu, Sarawak, 96000, Malaysia

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, 25100, Malaysia

  • Hospital Universitari Arnau de Vilanova

    Lleida, Lerida, 25198, Spain

  • Hospital Universitario 12 De Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013, Spain

  • Hospital de Clinicas de Porto Alegre HCPA PPDS

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hyogo Prefectural Nishinomiya General Medical Center

    Hyōgo, 663-8241, Japan

  • Hôpital de Rangueil

    Toulouse, 31059, France

  • IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit

    Pavia, Lombardy, 27100, Italy

  • Instituto D?Or Pesquisa e Ensino - Hospital Gloria D?Or

    Rio de Janeiro, 22281, Brazil

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, S2013DTC, Argentina

  • Instituto Mexicano de Trasplantes

    Cuernavaca, Morelos, 62448, Mexico

  • Iwate Medical University Hospital

    Numakunai, 028-3695, Japan

  • Japanese Red Cross Fukuoka Hospital

    Fukuoka, 815-8555, Japan

  • Jichi Medical University Hospital

    Tochigi, 329-0498, Japan

  • Juntendo University Hospital

    Tokyo, 113-8431, Japan

  • Juntendo University Nerima Hospital, department of renal and hypertension

    Tokyo, 177-8521, Japan

  • Juntendo University Urayasu Hospital

    Chiba, 279-0021, Japan

  • Kanazawa Medical University Hospital

    Ishikawa, 920-0293, Japan

  • Kidney Disease Medical Group Inc-1505 Wilson Ter

    Glendale, California, 91206-4032, United States

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Klinikum Koln-Merheim

    Cologne, 51109, Germany

  • Konkuk University Medical Center

    Seoul, 05030, South Korea

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Kyoto City Hospital

    Nakagyo-ku, 604-8845, Japan

  • L&C Professional Medical Research Institute

    West Miami, Florida, 33144, United States

  • Leicester General Hospital

    Leicester, LE5 4PW, United Kingdom

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • London Health Sciences Centre · Victoria Hospital

    London, Ontario, N6A 5W9, Canada

  • Mackay Memorial Hospital-Taipei branch

    Zhongshan Dist., 10449, Taiwan

  • Massachussets General Hospital

    Boston, Massachusetts, 02114, United States

  • Matsuyama Red Cross Hospital

    Ehime, 790-8524, Japan

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Miri Hospital

    Miri, 98000, Malaysia

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4, Canada

  • Nara Medical University Hospital

    Kashihara, 634-8522, Japan

  • Nara Prefecture General Medical Center

    Nara, 630-8054, Japan

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192, Japan

  • National University Hospital

    Singapore, 119074, Singapore

  • Nepean Hospital

    Kingswood, New South Wales, 02747, Australia

  • Nephrologisches Zentrum Villingen-Schwenningen

    Villingen-Schwenningen, 78052, Germany

  • Nephrology Associates of Northern Illinois

    Hinsdale, Illinois, 60521, United States

  • Nephrology Associates of Northern Virginia Inc

    Fairfax, Virginia, 22033, United States

  • Ningbo No.2 Hospital

    Ningbo, 315000, China

  • North America Research Institute-San Dimas

    San Dimas, California, 91773, United States

  • North Carolina Nephrology, PA

    Raleigh, North Carolina, 27609, United States

  • Okayama University Hospital

    Okayama-Shi Kita-Ku, 700-0914, Japan

  • Osaka University Hospital

    Suita, 565-0871, Japan

  • Ospedale Policlinico San Martino

    Genoa, Liguria, 16132, Italy

  • Ospedale San Giovanni Bosco

    Turin, Piedmont, 10154, Italy

  • Peking University First Hospital

    Beijing, 100034, China

  • Peking University People's Hospital

    Beijing, 100044, China

  • Pioneer Research Solutions

    Houston, Texas, 077099, United States

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Prolato Clinical Research Center

    Houston, Texas, 77054, United States

  • Queen Mary Hospital

    Hong Kong, 999077, Hong Kong

  • R & H Clinical Research

    Katy, Texas, 77449, United States

  • Renmin Hospital of Wuhan University

    Wuhan, 430060, China

  • Revival Research Institute - McKinney

    McKinney, Texas, 75071, United States

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376, Germany

  • Royal Adelaide Hospital

    Adelaide, South Australia, SA5000, Australia

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200025, China

  • SCM Clinic - Prywatny Szpital Specjalistyczny

    Krakow, 31-559, Poland

  • SMG-SNU Boramae Medical Center

    Seoul, 156-707, South Korea

  • SPZOZ Centralny Szpital Klin

    Lodz, 92-213, Poland

  • Saitama Medical University Hospital

    Saitama, 350-0451, Japan

  • Salford Royal Hospital

    Salford, M6 8HD, United Kingdom

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sanatorio Allende

    Córdoba, X5000JHQ, Argentina

  • Sanatorio Mayo Privado

    Córdoba, 5000, Argentina

  • Santa Casa de Misericordia de Belo Horizonte - PPDS

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shenzhen People's Hospital

    Shenzhen, 518020, China

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, 610072, China

  • Sierra Nevada Nephrology Consultants

    Reno, Nevada, 89511, United States

  • Singapore General Hospital

    Singapore, 169608, Singapore

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, 310016, China

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, 420-767, South Korea

  • St George Hospital

    Kogarah, New South Wales, 2217, Australia

  • St. Joseph-Krankenhaus

    Berlin, 12101, Germany

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Sunshine Hospital

    St Albans, Victoria, 3021, Australia

  • Szpital Kliniczny Dzieciatka Jezus

    Warsaw, 02-006, Poland

  • Taichung Veterans General Hospital

    Xitun Dist., 40705, Taiwan

  • Taiping Hospital

    Taiping, Perak, 34000, Malaysia

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • Texas Kidney Institute - Dallas

    Dallas, Texas, 75231, United States

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330000, China

  • The First Affiliated Hospital of Xian Jiao Tong University

    Xi'an, 710061, China

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050031, China

  • The Jikei University Hospital

    Tokyo, 105-8471, Japan

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210003, China

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004, China

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen, 518053, China

  • Tohoku University Hospital

    Miyagi, 980-8574, Japan

  • Tokushima University Hospital

    Tokushima, 770-8503, Japan

  • Tokyo Medical University Ibaraki Medical Center

    Inashiki-Gun, 300-0395, Japan

  • Tokyo Women's Medical University Hospital

    Tokyo, 162-8666, Japan

  • UAB Nephrology Research Clinic

    Birmingham, Alabama, 35233, United States

  • Universitatsklinikum der RWTH Aachen

    Aachen, 52074, Germany

  • University General Hospital of Heraklion

    Heraklion, 71110, Greece

  • University General Hospital of Patras

    Pátrai, 265 04, Greece

  • University Malaya Medical Centre

    Kuala Lumpur, FED. Territory of Kuala Lumpur, 59100, Malaysia

  • University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica

    Los Angeles, California, 90025-4837, United States

  • University of Tsukuba Hospital

    Tsukuba, 305-8576, Japan

  • University of Yamanashi Hospital

    Chūō, 409-3821, Japan

  • University of the Ryukyus Hospital

    Okinawa, 903-0125, Japan

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55101, Germany

  • Uniwersytecki Szpital Kliniczny w Opolu

    Opole, 45401, Poland

  • Uniwersytecki Szpital Kliniczny w Poznaniu - Przybyszewskiego 49

    Poznan, 60-355, Poland

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Venizeleio General Hospital of Heraklion

    Heraklion, 714 09, Greece

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808, Czechia

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023, China

  • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

    Shanghai, China

  • Yamaguchi University Hospital

    Ube, 755-8505, Japan

  • Zhejiang Provincial People?s Hospital

    Hangzhou, 310014, China

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