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New drug shows promise for slowing kidney disease in IgA nephropathy patients

NCT ID NCT05248659

Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the long-term safety of a drug called sibeprenlimab for people with IgA nephropathy, a kidney disease. About 600 adults who completed earlier trials of this drug will continue receiving it for up to 2 more years. Researchers will track side effects and measure how well the kidneys are working over time.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Dec 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: * Subjects who completed Trial 417-201-00007 (at least 20 of the 26 doses over a 2-year duration and the end-of-trial visit) or Trial VIS649-201 (at least 9 of the 12 doses over a 1-year duration and the end-of-trial visit) without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab for IgAN. * Ability to provide written, informed consent prior to initiation of any trial-specific procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial. Exclusion Criteria: * Subjects who have not completed participation in Trials 417-201-00007 or VIS649-201. * Subjects with treatment-limiting AEs during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement. * Noncompliance, due to subject's repeated failure to follow trial procedures during the course of their participation in Trials 417-201-00007 and VIS649-201 (eg, subjects deemed to be noncompliant with the visit schedule, trial assessments, or treatment regimen). The medical monitor should be contacted if the investigator is unsure of a subject's eligibility. * Subjects who have a positive pregnancy test result prior to receiving IMP. * Heterosexually active biological males or subjects of childbearing potential, or their partners, who do not agree to adhere to contraceptive requirements from the time of consent through the end of the subject's participation in the trial and an additional 90 days (biological male subjects) or 30 days (biological female subjects) thereafter. * Biological male subjects who do not agree to avoid donation of sperm from the time of consent through the end of the subject's participation in the trial and an additional 90 days thereafter. * Subject has nephrotic syndrome, defined for this purpose as 24-hour urine protein \> 3.5 g with concurrent hypoalbuminemia (serum albumin \< 2.5 g/dL), hyperlipidemia (total cholesterol \> 350 mg/dL), and edema. Subjects with isolated nephrotic range proteinuria (\> 3.5 g/day) will be eligible. * Subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, rheumatologic, blood dyscrasias or other medical disorder, including psychiatric disorders, cirrhosis, or ongoing malignancy. History of minor skin cancers (not including melanoma) or surgically treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary. * History of a previous hypersensitivity or severe allergic reaction with generalized urticaria, angioedema or anaphylaxis to any of the ingredients of the sibeprenlimab SC injection formulation. * Subject has a body mass index \< 16 kg/m\^2. * Subject has received an organ transplant (ie, solid or a bone marrow or hematologic stem cell transplantation). * Subject is currently receiving, or has received within 16 weeks prior to enrollment, systemic immunosuppressive therapy (ie, steroids such as targeted release budesonide, complement inhibitors, mycophenolate, rituximab). Note: topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids, and short courses of oral/intravenous steroids (\<= 14 days) are allowed.

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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.

Immunoglobulin A nephropathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    158 sites in 31 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CISSS de la Monteregie centre-Centre de recherche Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Clinica Nefrologica, Dialisi e Trapianto, IRCCS Ospedale Policlinico San Martino

    Genova, 16132, Italy

  • Clinical Research Site

    New Lambton Heights, New South Wales, 2305, Australia

  • Clinical Research Site #001

    Fitzroy, Victoria, 3065, Australia

  • Clinical Research Site #003

    Garran, Australian Capital Territory, 2605, Australia

  • Clinical Research Site #006

    Saint Leonards, New South Wales, 2065, Australia

  • Clinical Research Site #010

    St Albans, Victoria, 3021, Australia

  • Clinical Research Site #011

    Liverpool, 2170, Australia

  • Clinical Research Site #012

    Adelaide, South Australia, 5000, Australia

  • Clinical Research Site #013

    Concord, New South Wales, 2139, Australia

  • Clinical Research Site #014

    Kogarah, New South Wales, 2217, Australia

  • Clinical Research Site #020

    Beijing, Beijing Municipality, 100034, China

  • Clinical Research Site #022

    Nanchang, Jiangxi, 330006, China

  • Clinical Research Site #025

    Yibin, Sichuan, 644002, China

  • Clinical Research Site #026

    Jinan, Shandong, 250013, China

  • Clinical Research Site #028

    Guangzhou, Guangdong, 510120, China

  • Clinical Research Site #030

    Wuxi, Jiangsu, 214023, China

  • Clinical Research Site #036

    Beijing, Beijing Municipality, 100029, China

  • Clinical Research Site #038

    Chengdu, Sichuan, 610072, China

  • Clinical Research Site #044

    Changsha, Hunan, 410011, China

  • Clinical Research Site #060

    Hong Kong, 999077, Hong Kong

  • Clinical Research Site #061

    Hong Kong, 999077, Hong Kong

  • Clinical Research Site #062

    Kowloon, 999077, Hong Kong

  • Clinical Research Site #063

    Shatin, 999077, Hong Kong

  • Clinical Research Site #064

    Hong Kong, New Territories, Hong Kong

  • Clinical Research Site #070

    Nadiād, Gujarat, 387001, India

  • Clinical Research Site #071

    Kozhikode, Kerala, 673008, India

  • Clinical Research Site #073

    Ahmedabad, Gujarat, 382421, India

  • Clinical Research Site #074

    Thiruvananthapuram, Kerala, 695011, India

  • Clinical Research Site #075

    New Delhi, National Capital Territory of Delhi, 1100060, India

  • Clinical Research Site #076

    Lucknow, Uttar Pradesh, 226014, India

  • Clinical Research Site #077

    Chandigarh, Punjab, 160012, India

  • Clinical Research Site #078

    Afzalganj, Telangana, 500012, India

  • Clinical Research Site #079

    Manipal, Karnataka, 576104, India

  • Clinical Research Site #080

    Rajipet, Tamil Nadu, 632517, India

  • Clinical Research Site #081

    Hyderabad, Deccan, 500082, India

  • Clinical Research Site #084

    Pune, Maharashtra, 411057, India

  • Clinical Research Site #087

    Bengaluru, Karnataka, 560099, India

  • Clinical Research Site #100

    Seoul, Seoul Teugbyeolsi, 6351, South Korea

  • Clinical Research Site #102

    Busan, Busan Gwang'yeogsi, 49241, South Korea

  • Clinical Research Site #103

    Seoul, 3722, South Korea

  • Clinical Research Site #104

    Anyang, 14060, South Korea

  • Clinical Research Site #105

    Seoul, 134-727, South Korea

  • Clinical Research Site #106

    Seoul, 5355, South Korea

  • Clinical Research Site #107

    Seoul, 3080, South Korea

  • Clinical Research Site #108

    Seoul, 5030, South Korea

  • Clinical Research Site #109

    Hwaseong-si, 18450, South Korea

  • Clinical Research Site #110

    Seongnam, 13620, South Korea

  • Clinical Research Site #111

    Seoul, Seoul Teugbyeolsi, 18450, South Korea

  • Clinical Research Site #112

    Daegu, Daegu Gwang'yeogsi, 41944, South Korea

  • Clinical Research Site #113

    Gwangju, Gwangju Gwang'yeogsi, 61469, South Korea

  • Clinical Research Site #120

    Kuantan, 25100, Malaysia

  • Clinical Research Site #121

    Kuala Lumpur, 59100, Malaysia

  • Clinical Research Site #123

    Kuala Lumpur, 50586, Malaysia

  • Clinical Research Site #124

    Ipoh, Perak, 30450, Malaysia

  • Clinical Research Site #125

    Kuala Lumpur, 56000, Malaysia

  • Clinical Research Site #126

    Petaling Jaya, Selangor, 47150, Malaysia

  • Clinical Research Site #131

    Quezon City, 1112, Philippines

  • Clinical Research Site #132

    Quezon City, 1101, Philippines

  • Clinical Research Site #140

    Singapore, 308433, Singapore

  • Clinical Research Site #141

    Singapore, 169608, Singapore

  • Clinical Research Site #142

    Singapore, 119074, Singapore

  • Clinical Research Site #150

    Nugegoda, 10250, Sri Lanka

  • Clinical Research Site #151

    Colombo, 8, Sri Lanka

  • Clinical Research Site #152

    Kandy, 20000, Sri Lanka

  • Clinical Research Site #154

    Kurunegala, 60000, Sri Lanka

  • Clinical Research Site #160

    Keelung, 20104, Taiwan

  • Clinical Research Site #161

    Kaohsiung City, 83301, Taiwan

  • Clinical Research Site #163

    New Taipei City, 23561, Taiwan

  • Clinical Research Site #164

    Taipei, 10002, Taiwan

  • Clinical Research Site #165

    Taipei, 112202, Taiwan

  • Clinical Research Site #170

    Bangkok, 10310, Thailand

  • Clinical Research Site #171

    Din Daeng, 10400, Thailand

  • Clinical Research Site #172

    Chiang Mai, 50200, Thailand

  • Clinical Research Site #173

    Khon Kaen, 40002, Thailand

  • Clinical Research Site #175

    Bangkok, 1, Thailand

  • Clinical Research Site #181

    Hanoi, 0, Vietnam

  • Clinical Research Site #300

    Calgary, Alberta, T2R 0X7, Canada

  • Clinical Research Site #305

    Scarborough Village, Ontario, M1H 3G4, Canada

  • Clinical Research Site #320

    Shelby, Michigan, 48315, United States

  • Clinical Research Site #323

    Lauderdale Lakes, Florida, 33313, United States

  • Clinical Research Site #324

    Houston, Texas, 77030, United States

  • Clinical Research Site #325

    Los Angeles, California, 90027, United States

  • Clinical Research Site #330

    Denver, Colorado, 80220, United States

  • Clinical Research Site #331

    Worcester, Massachusetts, 01655, United States

  • Clinical Research Site #336

    Birmingham, Alabama, 35233, United States

  • Clinical Research Site #346

    Great Neck, New York, 11021, United States

  • Clinical Research Site #350

    Columbus, Ohio, 43210, United States

  • Clinical Research Site #356

    Lawrenceville, Georgia, 30046, United States

  • Clinical Research Site #361

    Milwaukee, Wisconsin, 53213, United States

  • Clinical Research Site #369

    Boston, Massachusetts, 02114, United States

  • Clinical Research Site #370

    Palo Alto, California, 94304, United States

  • Clinical Research Site #373

    Atlanta, Georgia, 30342, United States

  • Clinical Research Site #374

    Dakota Dunes, South Dakota, 57029, United States

  • Clinical Research Site #401

    Genk, 3600, Belgium

  • Clinical Research Site #405

    Genk, 3600, Belgium

  • Clinical Research Site #413

    Split, 21000, Croatia

  • Clinical Research Site #414

    Zagreb, 10000, Croatia

  • Clinical Research Site #430

    Nîmes, Gard, 30900, France

  • Clinical Research Site #432

    Nantes, Loire-Atlantique, 44093, France

  • Clinical Research Site #433

    Grenoble, Auvergne-Rhône-Alpes, 38043, France

  • Clinical Research Site #434

    Sr Priest En Jarez, Pays de la Loire Region, 42270, France

  • Clinical Research Site #439

    Limoges, New Aquitaine, 87000, France

  • Clinical Research Site #455

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Clinical Research Site #472

    Heraklion, 71110, Greece

  • Clinical Research Site #482

    Pécs, Baranya, 7624, Hungary

  • Clinical Research Site #493

    Petach Tiqwa, 49100, Israel

  • Clinical Research Site #494

    Ashkelon, 7830604, Israel

  • Clinical Research Site #495

    Nahariya, 22100, Israel

  • Clinical Research Site #507

    Piacenza, 29121, Italy

  • Clinical Research Site #509

    Pavia, 27100, Italy

  • Clinical Research Site #512

    Bologna, 40138, Italy

  • Clinical Research Site #530

    Lodz, Łódź Voivodeship, 92-213, Poland

  • Clinical Research Site #535

    Krakow, 31-513, Poland

  • Clinical Research Site #540

    Braga, 4710-243, Portugal

  • Clinical Research Site #543

    Porto, 4434-502, Portugal

  • Clinical Research Site #544

    Porto, 4200-319, Portugal

  • Clinical Research Site #545

    Carnaxide, 2790-134, Portugal

  • Clinical Research Site #561

    Seville, 41013, Spain

  • Clinical Research Site #562

    Seville, 41009, Spain

  • Clinical Research Site #563

    Barcelona, 8907, Spain

  • Clinical Research Site #564

    Ellenboro, 28040, Spain

  • Clinical Research Site #565

    Córdoba, 14004, Spain

  • Clinical Research Site #566

    Barcelona, 8035, Spain

  • Clinical Research Site #567

    Barcelona, 8025, Spain

  • Clinical Research Site #570

    Madrid, 28222, Spain

  • Clinical Research Site #573

    Madrid, 28034, Spain

  • Clinical Research Site #581

    Leicester, LE5 4PW, United Kingdom

  • Clinical Research Site #582

    London, SE 5 9RS, United Kingdom

  • Clinical Research Site #584

    London, E1 1FR, United Kingdom

  • Clinical Research Site #700

    Chiba, Chiba, 260-8712, Japan

  • Clinical Research Site #703

    Fukuoka, 812-8582, Japan

  • Clinical Research Site #705

    Nagoya, Aichi-ken, 466-8560, Japan

  • Clinical Research Site #707

    Urayasu-shi, Chiba, 279-002, Japan

  • Clinical Research Site #708

    Tsukuba, Ibaraki, 305-8576, Japan

  • Clinical Research Site #709

    Toyoake-shi, Aichi-ken, 470-1192, Japan

  • Clinical Research Site #712

    Minatoku, 105-8471, Japan

  • Clinical Research Site #713

    Kashihara, Nara, 634-8522, Japan

  • Clinical Research Site #714

    Kawasaki-shi, Kanagawa, 213-8587, Japan

  • Clinical Research Site #715

    Bunkyo, Tokyo, 113-8431, Japan

  • Clinical Research Site #716

    Miyazaki, 889-1692, Japan

  • Clinical Research Site #717

    Yufu, Oita Prefecture, 879-5593, Japan

  • Clinical Research Site #724

    Kobe, Hyōgo, 650-0017, Japan

  • Clinical Research Site #726

    Tochigi, 326-0843, Japan

  • Clinical Research Site #727

    Nerima-ku, Tokyo, 177-8521, Japan

  • Clinical Research Site #800

    Buenos Aires, C1280AEB, Argentina

  • Clinical Research Site #801

    Córdoba, X5016LIG, Argentina

  • Clinical Research Site #802

    Buenos Aires, C1425, Argentina

  • Clinical Research Site #820

    Recife, Pernambuco, 50670-901, Brazil

  • Clinical Research Site #821

    Joinville, Santa Catarina, 89227-680, Brazil

  • Clinical Research Site #822

    São José do Rio Preto, So Paulo, 15090-000, Brazil

  • Clinical Research Site #823

    São Paulo, 01246-903, Brazil

  • Clinical Research Site #824

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Clinical Research Site #831

    Rio de Janeiro, 20550-010, Brazil

  • Radboud Universitair Medisch Centrum

    Nijmegen, Gelderland, 6500 HB, Netherlands

  • Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC) (Meir Hospital)

    Kfar Saba, 44281, Israel

  • Universitaetsklinikum Carl Gustav Carus

    Dresden, Saxony, 1307, Germany

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808, Czechia

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