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New shot shows promise in slowing kidney disease

NCT ID NCT05852938

Disease control Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study tests BION-1301 (Zigakibart) in 383 adults with IgA nephropathy, a kidney disease that can lead to kidney failure. Participants receive either the drug or a placebo as a shot every 2 weeks for 2 years. The main goal is to see if the drug helps preserve kidney function and reduce protein in the urine.

What this could mean

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

Active substance
BION-1301 (also called Zigakibart or FUB523), given as a shot under the skin every 2 weeks
What this could lead to
If it works, this could provide a new treatment option to slow kidney damage and delay the need for dialysis or transplant in people with IgA nephropathy.
What could go wrong
This is a large phase 3 trial, but results are not yet available. The drug may not improve kidney function enough or could have side effects. It is not a cure, and patients may still need ongoing care.

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

383 people

The number who actually took part.

Started

Jul 2023

Expected to finish

Jan 2028

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: * Male and female participants aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures. * Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Sponsor. * eGFR ≥ 30 mL/min/1.73m\^2 at Screening based on the 2021 CKD-EPI equation. * Total urine protein ≥ 1.0 g/day or UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory. * Stable on a maximally tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of sodium glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on a stable dose of ACEi, ARB, SGLT2i, ERAs, and/or MRAs for the duration of the study. Exclusion Criteria: * Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias. * Diagnosis of IgA Vasculitis. * Current or history of nephrotic syndrome. * Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for \> 14 days within 12 weeks prior to Screening. * Use of systemic immunosuppressant medications. * IgG levels \< 6 g/L at Screening. Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

chronic renal failure syndrome glomerulonephritis IgA glomerulonephritis kidney disorder urinary system disorder

As listed by the trial registrant

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

IgA nephropathy Immunoglobulin A nephropathy

Contacts and locations

Locations

  • Capital District Renal Physicians

    Clifton Park, New York, 12065, United States

  • Cleveland Clinic-9500 Euclid Ave

    Cleveland, Ohio, 44109-1900, United States

  • Columbia Nephrology Associates , P.A. - Columbia

    Columbia, South Carolina, 29203-6476, United States

  • DaVita Clinical Research

    El Paso, Texas, 79925, United States

  • Dallas Renal Group - 1411 N Beckley Ave

    Dallas, Texas, 75230, United States

  • Dallas Renal Group - Waxachie - 2460 N. I-35

    Dallas, Texas, 75237-3461, United States

  • Denver Nephrology Research Division

    Denver, Colorado, 80230-6441, United States

  • East Texas Nephrology Associates

    Lufkin, Texas, 75904-3132, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029-6504, United States

  • Intermed Consultants

    Edina, Minnesota, 55435-2129, United States

  • Knoxville Kidney Center, PLLC - Frenova F1

    Knoxville, Tennessee, 37923, United States

  • Nephrology Associales of Northern Illinois and Indiana

    Hinsdale, Illinois, 60521-3640, United States

  • Nephrology Associates PC - Flushing

    Flushing, New York, 11355-5045, United States

  • Nephrology Associates of Northern Illinois and Indiana - 7836 W Jefferson Blvd

    Fort Wayne, Indiana, 46804, United States

  • Nephrology Associates of Northern Virginia-8501 Arlington Blvd

    Fairfax, Virginia, 22033-1907, United States

  • Nephrology Consultants, LLC

    Huntsville, Alabama, 35805-4104, United States

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201-1700, United States

  • Northeast Clinical Research Center, LLC

    Bethlehem, Pennsylvania, 18017-2159, United States

  • Novartis Investigative Site

    La Plata, Buenos Aires, B1902COS, Argentina

  • Novartis Investigative Site

    Catamarca, Catamarca Province, K4700, Argentina

  • Novartis Investigative Site

    Barracas, Ciudad Autónoma de BuenosAires, C1280AEB, Argentina

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2013DTC, Argentina

  • Novartis Investigative Site

    Santa Fe, Santa Fe Province, S3000EPV, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1425, Argentina

  • Novartis Investigative Site

    Gosford, New South Wales, 2250, Australia

  • Novartis Investigative Site

    Kogarah, New South Wales, 2217, Australia

  • Novartis Investigative Site

    Liverpool, New South Wales, 2170, Australia

  • Novartis Investigative Site

    Penrith, New South Wales, 2750, Australia

  • Novartis Investigative Site

    St Leonards, New South Wales, 2065, Australia

  • Novartis Investigative Site

    Cairns North, Queensland, 4870, Australia

  • Novartis Investigative Site

    Box Hill, Victoria, 3128, Australia

  • Novartis Investigative Site

    St Albans, Victoria, 3021, Australia

  • Novartis Investigative Site

    Bonheiden, Antwerpen, 2820, Belgium

  • Novartis Investigative Site

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Novartis Investigative Site

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Novartis Investigative Site

    Liège, Liège, Belgium

  • Novartis Investigative Site

    Lodelinsart, 6042, Belgium

  • Novartis Investigative Site

    Woluwe-Saint-Lambert, 1200, Belgium

  • Novartis Investigative Site

    Santana, Amapá, 68925-000, Brazil

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30130-100, Brazil

  • Novartis Investigative Site

    Maringá, Paraná, 87013-040, Brazil

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

  • Novartis Investigative Site

    Joinville, Santa Catarina, 89227-680, Brazil

  • Novartis Investigative Site

    São Bernardo do Campo, São Paulo, 09780-000, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01323-001, Brazil

  • Novartis Investigative Site

    São Paulo, 04023-900, Brazil

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Novartis Investigative Site

    Brampton, Ontario, L6Z 4N5, Canada

  • Novartis Investigative Site

    East York, Ontario, M4C 5T2, Canada

  • Novartis Investigative Site

    London, Ontario, N6A 5A5, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2N2, Canada

  • Novartis Investigative Site

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4, Canada

  • Novartis Investigative Site

    Hefei, Anhui, 230601, China

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100034, China

  • Novartis Investigative Site

    Foshan, Guangdong, 528000, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510280, China

  • Novartis Investigative Site

    Shenzhen, Guangdong, 518036, China

  • Novartis Investigative Site

    Nanning, Guangxi, 530021, China

  • Novartis Investigative Site

    Guiyang, Guizhou, 550002, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430060, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029, China

  • Novartis Investigative Site

    Nantong, Jiangsu, 226001, China

  • Novartis Investigative Site

    Wuxi, Jiangsu, 214023, China

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330006, China

  • Novartis Investigative Site

    Jinan, Shandong, 250021, China

  • Novartis Investigative Site

    Qingdao, Shandong, 266005, China

  • Novartis Investigative Site

    Shanghai, Shanghai Municipality, 200040, China

  • Novartis Investigative Site

    Taiyuan, Shanxi, 030001, China

  • Novartis Investigative Site

    Taiyuan, Shanxi, 650000, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610072, China

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830001, China

  • Novartis Investigative Site

    Wulumuji, Xinjiang, 830054, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310009, China

  • Novartis Investigative Site

    Taizhou, Zhejiang, 317000, China

  • Novartis Investigative Site

    Zagreb, City of Zagreb, 10000, Croatia

  • Novartis Investigative Site

    Biškupec Zelinski, 10380, Croatia

  • Novartis Investigative Site

    Rijeka, 51000, Croatia

  • Novartis Investigative Site

    Vinkovci, 32100, Croatia

  • Novartis Investigative Site

    Prague, Praha, Hlavní Mesto, 128 08, Czechia

  • Novartis Investigative Site

    Nîmes, Gard, 30029, France

  • Novartis Investigative Site

    Lille, Nord, 59000, France

  • Novartis Investigative Site

    Lyon, Rhône, 69437, France

  • Novartis Investigative Site

    Grenoble, 38043, France

  • Novartis Investigative Site

    Paris, 75010, France

  • Novartis Investigative Site

    Paris, 75015, France

  • Novartis Investigative Site

    Augsburg, Bavaria, 86156, Germany

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30459, Germany

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30625, Germany

  • Novartis Investigative Site

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Novartis Investigative Site

    Trier, Rhineland-Palatinate, 54292, Germany

  • Novartis Investigative Site

    Magdeburg, Saxony-Anhalt, 39120, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07747, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Pátrai, Achaïa, 265 04, Greece

  • Novartis Investigative Site

    Athens, Attica, 12462, Greece

  • Novartis Investigative Site

    Kalamaria, Thessaloniki, 551 34, Greece

  • Novartis Investigative Site

    Heralkion, 71409, Greece

  • Novartis Investigative Site

    Ioannina, 450 01, Greece

  • Novartis Investigative Site

    Ioannina, 455 00, Greece

  • Novartis Investigative Site

    Thessaloniki, 546 29, Greece

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500084, India

  • Novartis Investigative Site

    Chandigarh, Chandigarh, 160012, India

  • Novartis Investigative Site

    Faridabad, Haryana, 121002, India

  • Novartis Investigative Site

    Bengaluru, Karnataka, 560004, India

  • Novartis Investigative Site

    Trivandrum, Kerala, 695011, India

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302001, India

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302017, India

  • Novartis Investigative Site

    Vellore, Tamil Nadu, 632004, India

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226005, India

  • Novartis Investigative Site

    Kolkata, West Bengal, 700014, India

  • Novartis Investigative Site

    Dehradun, 248001, India

  • Novartis Investigative Site

    Beersheba, Southern District, 84101, Israel

  • Novartis Investigative Site

    Holon, Tel Aviv, 58000, Israel

  • Novartis Investigative Site

    Ramat Gan, Tel Aviv, 52394, Israel

  • Novartis Investigative Site

    Be’er Ya‘aqov, 70300, Israel

  • Novartis Investigative Site

    Ramat Gan, 5262100, Israel

  • Novartis Investigative Site

    Tel Aviv, 64239, Israel

  • Novartis Investigative Site

    Bari, Apulia, 70124, Italy

  • Novartis Investigative Site

    Foggia, Apulia, 71100, Italy

  • Novartis Investigative Site

    Naples, Campania, 80131, Italy

  • Novartis Investigative Site

    Modena, Emilia-Romagna, 41124, Italy

  • Novartis Investigative Site

    Trieste, Friuli Venezia Giulia, 34149, Italy

  • Novartis Investigative Site

    Pavia, Lombardy, 27100, Italy

  • Novartis Investigative Site

    Ranica, Lombardy, 24020, Italy

  • Novartis Investigative Site

    Kasugai-Shi, Aiti, 486-0804, Japan

  • Novartis Investigative Site

    Toyoake-shi, Aiti, 470-1192, Japan

  • Novartis Investigative Site

    Urayasu-Shi, Chiba, 279-0021, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaidô, 060-8604, Japan

  • Novartis Investigative Site

    Kitakyushu, Hukuoka, 802-8555, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 236-0004, Japan

  • Novartis Investigative Site

    Kashihara, Nara, 634-8522, Japan

  • Novartis Investigative Site

    Nara, Nara, 630-8581, Japan

  • Novartis Investigative Site

    Osaka, Osaka, 558-0056, Japan

  • Novartis Investigative Site

    Bunkyo-Ku, Tokyo, 113-8431, Japan

  • Novartis Investigative Site

    Hachioji-Shi, Tokyo, 192-0071, Japan

  • Novartis Investigative Site

    Minato-Ku, Tokyo, 105-8471, Japan

  • Novartis Investigative Site

    Shinjuku-Ku, Tokyo, 162-0054, Japan

  • Novartis Investigative Site

    Chiba, 260-8712, Japan

  • Novartis Investigative Site

    Niigata, 951-8520, Japan

  • Novartis Investigative Site

    Okayama, 700-8558, Japan

  • Novartis Investigative Site

    Tokyo, 105-8470, Japan

  • Novartis Investigative Site

    Yufu-Shi, Ôita, 879-5503, Japan

  • Novartis Investigative Site

    Kuantan, Pahang, 25100, Malaysia

  • Novartis Investigative Site

    Sibu, Sarawak, 96000, Malaysia

  • Novartis Investigative Site

    Kajang, Selangor, 43000, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, WilayahPersekutuan KualaLumpur, 50586, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, WilayahPersekutuan KualaLumpur, 59100, Malaysia

  • Novartis Investigative Site

    Chihuahua, Chiapas, 31217, Mexico

  • Novartis Investigative Site

    Barrio Belisario Domínguez Secc, Mexico City, 14080, Mexico

  • Novartis Investigative Site

    Oaxaca, Mexico City, 68000, Mexico

  • Novartis Investigative Site

    Aguascalientes, 20259, Mexico

  • Novartis Investigative Site

    Chihuahua City, 64060, Mexico

  • Novartis Investigative Site

    Monterrey, 64060, Mexico

  • Novartis Investigative Site

    Dongan-Gu, Anyang-Si, Gyeonggido, 14068, South Korea

  • Novartis Investigative Site

    Guri-si, Gyeonggido, South Korea

  • Novartis Investigative Site

    Uijeongbu-si, Gyeonggido, 11765, South Korea

  • Novartis Investigative Site

    Jongno-gu, Seoul Teugbyeolsi, 03080, South Korea

  • Novartis Investigative Site

    Seodaemun-gu, Seoul Teugbyeolsi, 03722, South Korea

  • Novartis Investigative Site

    Seongbuk-Gu, Seoul Teugbyeolsi, 02841, South Korea

  • Novartis Investigative Site

    Cheonan, South Korea

  • Novartis Investigative Site

    Daejeon, 301721, South Korea

  • Novartis Investigative Site

    Seoul, 06973, South Korea

  • Novartis Investigative Site

    Manises, Valencia, 46940, Spain

  • Novartis Investigative Site

    Barcelona, 8035, Spain

  • Novartis Investigative Site

    Girona, 17007, Spain

  • Novartis Investigative Site

    Lleida, 25198, Spain

  • Novartis Investigative Site

    Lugo, 27880, Spain

  • Novartis Investigative Site

    Madrid, 28007, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Seville, 41009, Spain

  • Novartis Investigative Site

    Keelung, Keelung, 204, Taiwan

  • Novartis Investigative Site

    Changhua County, 50006, Taiwan

  • Novartis Investigative Site

    Hsinchu, Taiwan

  • Novartis Investigative Site

    Hualien City, 970, Taiwan

  • Novartis Investigative Site

    Kaohsiung City, Taiwan

  • Novartis Investigative Site

    Tainan, 704, Taiwan

  • Novartis Investigative Site

    Taipei, 100, Taiwan

  • Novartis Investigative Site

    Taipei, 116, Taiwan

  • Novartis Investigative Site

    Bornova, İzmir, 35100, Turkey (Türkiye)

  • Novartis Investigative Site

    İzmit, Kocaeli, 41380, Turkey (Türkiye)

  • Novartis Investigative Site

    Antalya, 07070, Turkey (Türkiye)

  • Novartis Investigative Site

    Kayseri, 38039, Turkey (Türkiye)

  • Novartis Investigative Site

    Bristol, Bristol, City of, BS10 5NB, United Kingdom

  • Novartis Investigative Site

    Brighton, East Sussex, BN2 5BE, United Kingdom

  • Novartis Investigative Site

    Salford, Lancashire, M6 8HD, United Kingdom

  • Novartis Investigative Site

    Leicester, Leicestershire, LE5 4PW, United Kingdom

  • Novartis Investigative Site

    London, London, City of, SE5 9RS, United Kingdom

  • Novartis Investigative Site

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • OHSU - Oregon Clinical and Translational Research Institute

    Portland, Oregon, 97239, United States

  • Swedish Center for Comprehensive Care

    Seattle, Washington, 98104, United States

  • University Of Iowa Hospitals And Clinics

    Iowa City, Iowa, 52242-1009, United States

  • University of Alabama at Birmingham: The Kirklin Clinic

    Birmingham, Alabama, 35233-1926, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Cincinnati College of Medicine - 231 Albert Sabin Way

    Cincinnati, Ohio, 45267-2827, United States

  • University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • University of Texas MD Anderson Cancer Center-1155 Pressler

    Houston, Texas, 77030-2348, United States

  • Valiance Clinical Research

    South Gate, California, 90280-5219, United States

  • Vida Medical Centers - Pembroke Pines

    Pembroke Pines, Florida, 33023-2213, United States

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