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AzTrials

IgA NephropathyPhase 3NCT05852938

A Study of Zigakibart in Adults With IgA Nephropathy

A Phase 3 study testing BION-1301 in people with IgA Nephropathy and Immunoglobulin A Nephropathy, run by Novartis Pharmaceuticals at 200 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
IgA Nephropathy, Immunoglobulin A Nephropathy
What is being tested?
BION-1301
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
383 participants
Where
200 sitesin 23 countries
Study dates
6 Jul 2023to 25 Jan 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

200 sites in 23 countries.

200 sites in 23 countries

United States28 sites

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Northeast Clinical Research Center, LLC

    Bethlehem, Pennsylvania, 18017-2159

  • University of Alabama at Birmingham: The Kirklin Clinic

    Birmingham, Alabama, 35233-1926

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

    Cincinnati, Ohio, 45267-2827

  • Cleveland Clinic-9500 Euclid Ave

    Cleveland, Ohio, 44109-1900

  • Capital District Renal Physicians

    Clifton Park, New York, 12065

  • Columbia Nephrology Associates , P.A. - Columbia

    Columbia, South Carolina, 29203-6476

  • Dallas Renal Group - 1411 N Beckley Ave

    Dallas, Texas, 75230

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

    Dallas, Texas, 75237-3461

  • Denver Nephrology Research Division

    Denver, Colorado, 80230-6441

  • Intermed Consultants

    Edina, Minnesota, 55435-2129

  • DaVita Clinical Research

    El Paso, Texas, 79925

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201-1700

  • Nephrology Associates of Northern Virginia-8501 Arlington Blvd

    Fairfax, Virginia, 22033-1907

  • Nephrology Associates PC - Flushing

    Flushing, New York, 11355-5045

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

    Fort Wayne, Indiana, 46804

  • Nephrology Associales of Northern Illinois and Indiana

    Hinsdale, Illinois, 60521-3640

  • University of Texas MD Anderson Cancer Center-1155 Pressler

    Houston, Texas, 77030-2348

  • Nephrology Consultants, LLC

    Huntsville, Alabama, 35805-4104

  • University Of Iowa Hospitals And Clinics

    Iowa City, Iowa, 52242-1009

  • Knoxville Kidney Center, PLLC - Frenova F1

    Knoxville, Tennessee, 37923

  • East Texas Nephrology Associates

    Lufkin, Texas, 75904-3132

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029-6504

  • Vida Medical Centers - Pembroke Pines

    Pembroke Pines, Florida, 33023-2213

  • OHSU - Oregon Clinical and Translational Research Institute

    Portland, Oregon, 97239

  • University of California, San Francisco

    San Francisco, California, 94143

  • Swedish Center for Comprehensive Care

    Seattle, Washington, 98104

  • Valiance Clinical Research

    South Gate, California, 90280-5219

Other trials in United States

China23 sites

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100034

  • Novartis Investigative Site

    Chengdu, Sichuan, 610072

  • Novartis Investigative Site

    Foshan, Guangdong, 528000

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510280

  • Novartis Investigative Site

    Guiyang, Guizhou, 550002

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310009

  • Novartis Investigative Site

    Hefei, Anhui, 230601

  • Novartis Investigative Site

    Jinan, Shandong, 250021

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330006

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029

  • Novartis Investigative Site

    Nanning, Guangxi, 530021

  • Novartis Investigative Site

    Nantong, Jiangsu, 226001

  • Novartis Investigative Site

    Qingdao, Shandong, 266005

  • Novartis Investigative Site

    Shanghai, Shanghai Municipality, 200040

  • Novartis Investigative Site

    Shenzhen, Guangdong, 518036

  • Novartis Investigative Site

    Taiyuan, Shanxi, 030001

  • Novartis Investigative Site

    Taiyuan, Shanxi, 650000

  • Novartis Investigative Site

    Taizhou, Zhejiang, 317000

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830001

  • Novartis Investigative Site

    Wuhan, Hubei, 430060

  • Novartis Investigative Site

    Wulumuji, Xinjiang, 830054

  • Novartis Investigative Site

    Wuxi, Jiangsu, 214023

Other trials in China

Japan18 sites

  • Novartis Investigative Site

    Bunkyo-Ku, Tokyo, 113-8431

  • Novartis Investigative Site

    Chiba, 260-8712

  • Novartis Investigative Site

    Hachioji-Shi, Tokyo, 192-0071

  • Novartis Investigative Site

    Kashihara, Nara, 634-8522

  • Novartis Investigative Site

    Kasugai-Shi, Aiti, 486-0804

  • Novartis Investigative Site

    Kitakyushu, Hukuoka, 802-8555

  • Novartis Investigative Site

    Minato-Ku, Tokyo, 105-8471

  • Novartis Investigative Site

    Nara, Nara, 630-8581

  • Novartis Investigative Site

    Niigata, 951-8520

  • Novartis Investigative Site

    Okayama, 700-8558

  • Novartis Investigative Site

    Osaka, Osaka, 558-0056

  • Novartis Investigative Site

    Sapporo, Hokkaidô, 060-8604

  • Novartis Investigative Site

    Shinjuku-Ku, Tokyo, 162-0054

  • Novartis Investigative Site

    Tokyo, 105-8470

  • Novartis Investigative Site

    Toyoake-shi, Aiti, 470-1192

  • Novartis Investigative Site

    Urayasu-Shi, Chiba, 279-0021

  • Novartis Investigative Site

    Yokohama, Kanagawa, 236-0004

  • Novartis Investigative Site

    Yufu-Shi, Ôita, 879-5503

Other trials in Japan

India11 sites

  • Novartis Investigative Site

    Bengaluru, Karnataka, 560004

  • Novartis Investigative Site

    Chandigarh, Chandigarh, 160012

  • Novartis Investigative Site

    Dehradun, 248001

  • Novartis Investigative Site

    Faridabad, Haryana, 121002

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500084

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302001

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302017

  • Novartis Investigative Site

    Kolkata, West Bengal, 700014

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226005

  • Novartis Investigative Site

    Trivandrum, Kerala, 695011

  • Novartis Investigative Site

    Vellore, Tamil Nadu, 632004

Other trials in India

South Korea9 sites

  • Novartis Investigative Site

    Cheonan

  • Novartis Investigative Site

    Daejeon, 301721

  • Novartis Investigative Site

    Dongan-Gu, Anyang-Si, Gyeonggido, 14068

  • Novartis Investigative Site

    Guri-si, Gyeonggido

  • Novartis Investigative Site

    Jongno-gu, Seoul Teugbyeolsi, 03080

  • Novartis Investigative Site

    Seodaemun-gu, Seoul Teugbyeolsi, 03722

  • Novartis Investigative Site

    Seongbuk-Gu, Seoul Teugbyeolsi, 02841

  • Novartis Investigative Site

    Seoul, 06973

  • Novartis Investigative Site

    Uijeongbu-si, Gyeonggido, 11765

Other trials in South Korea

Australia8 sites

  • Novartis Investigative Site

    Box Hill, Victoria, 3128

  • Novartis Investigative Site

    Cairns North, Queensland, 4870

  • Novartis Investigative Site

    Gosford, New South Wales, 2250

  • Novartis Investigative Site

    Kogarah, New South Wales, 2217

  • Novartis Investigative Site

    Liverpool, New South Wales, 2170

  • Novartis Investigative Site

    Penrith, New South Wales, 2750

  • Novartis Investigative Site

    St Albans, Victoria, 3021

  • Novartis Investigative Site

    St Leonards, New South Wales, 2065

Other trials in Australia

Brazil8 sites

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30130-100

  • Novartis Investigative Site

    Joinville, Santa Catarina, 89227-680

  • Novartis Investigative Site

    Maringá, Paraná, 87013-040

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-074

  • Novartis Investigative Site

    Santana, Amapá, 68925-000

  • Novartis Investigative Site

    São Bernardo do Campo, São Paulo, 09780-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 01323-001

  • Novartis Investigative Site

    São Paulo, 04023-900

Other trials in Brazil

Germany8 sites

  • Novartis Investigative Site

    Augsburg, Bavaria, 86156

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30459

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30625

  • Novartis Investigative Site

    Jena, Thuringia, 07747

  • Novartis Investigative Site

    Magdeburg, Saxony-Anhalt, 39120

  • Novartis Investigative Site

    Mainz, Rhineland-Palatinate, 55131

  • Novartis Investigative Site

    Trier, Rhineland-Palatinate, 54292

Other trials in Germany

Spain8 sites

  • Novartis Investigative Site

    Barcelona, 8035

  • Novartis Investigative Site

    Girona, 17007

  • Novartis Investigative Site

    Lleida, 25198

  • Novartis Investigative Site

    Lugo, 27880

  • Novartis Investigative Site

    Madrid, 28007

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Manises, Valencia, 46940

  • Novartis Investigative Site

    Seville, 41009

Other trials in Spain

Taiwan8 sites

  • Novartis Investigative Site

    Changhua County, 50006

  • Novartis Investigative Site

    Hsinchu

  • Novartis Investigative Site

    Hualien City, 970

  • Novartis Investigative Site

    Kaohsiung City

  • Novartis Investigative Site

    Keelung, Keelung, 204

  • Novartis Investigative Site

    Tainan, 704

  • Novartis Investigative Site

    Taipei, 100

  • Novartis Investigative Site

    Taipei, 116

Other trials in Taiwan

Canada7 sites

  • Novartis Investigative Site

    Brampton, Ontario, L6Z 4N5

  • Novartis Investigative Site

    East York, Ontario, M4C 5T2

  • Novartis Investigative Site

    Greenfield Park, Quebec, J4V 2H1

  • Novartis Investigative Site

    London, Ontario, N6A 5A5

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2N2

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Greece7 sites

  • Novartis Investigative Site

    Athens, Attica, 12462

  • Novartis Investigative Site

    Heralkion, 71409

  • Novartis Investigative Site

    Ioannina, 450 01

  • Novartis Investigative Site

    Ioannina, 455 00

  • Novartis Investigative Site

    Kalamaria, Thessaloniki, 551 34

  • Novartis Investigative Site

    Pátrai, Achaïa, 265 04

  • Novartis Investigative Site

    Thessaloniki, 546 29

Other trials in Greece

Italy7 sites

  • Novartis Investigative Site

    Bari, Apulia, 70124

  • Novartis Investigative Site

    Foggia, Apulia, 71100

  • Novartis Investigative Site

    Modena, Emilia-Romagna, 41124

  • Novartis Investigative Site

    Naples, Campania, 80131

  • Novartis Investigative Site

    Pavia, Lombardy, 27100

  • Novartis Investigative Site

    Ranica, Lombardy, 24020

  • Novartis Investigative Site

    Trieste, Friuli Venezia Giulia, 34149

Other trials in Italy

Argentina6 sites

  • Novartis Investigative Site

    Barracas, Ciudad Autónoma de BuenosAires, C1280AEB

  • Novartis Investigative Site

    Buenos Aires, C1425

  • Novartis Investigative Site

    Catamarca, Catamarca Province, K4700

  • Novartis Investigative Site

    La Plata, Buenos Aires, B1902COS

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2013DTC

  • Novartis Investigative Site

    Santa Fe, Santa Fe Province, S3000EPV

Other trials in Argentina

Belgium6 sites

  • Novartis Investigative Site

    Bonheiden, Antwerpen, 2820

  • Novartis Investigative Site

    Ghent, Oost-Vlaanderen, 9000

  • Novartis Investigative Site

    Liège, Liège

  • Novartis Investigative Site

    Lodelinsart, 6042

  • Novartis Investigative Site

    Roeselare, West-Vlaanderen, 8800

  • Novartis Investigative Site

    Woluwe-Saint-Lambert, 1200

Other trials in Belgium

France6 sites

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    Lille, Nord, 59000

  • Novartis Investigative Site

    Lyon, Rhône, 69437

  • Novartis Investigative Site

    Nîmes, Gard, 30029

  • Novartis Investigative Site

    Paris, 75010

  • Novartis Investigative Site

    Paris, 75015

Other trials in France

Israel6 sites

  • Novartis Investigative Site

    Be’er Ya‘aqov, 70300

  • Novartis Investigative Site

    Beersheba, Southern District, 84101

  • Novartis Investigative Site

    Holon, Tel Aviv, 58000

  • Novartis Investigative Site

    Ramat Gan, Tel Aviv, 52394

  • Novartis Investigative Site

    Ramat Gan, 5262100

  • Novartis Investigative Site

    Tel Aviv, 64239

Other trials in Israel

Mexico6 sites

  • Novartis Investigative Site

    Aguascalientes, 20259

  • Novartis Investigative Site

    Barrio Belisario Domínguez Secc, Mexico City, 14080

  • Novartis Investigative Site

    Chihuahua, Chiapas, 31217

  • Novartis Investigative Site

    Chihuahua City, 64060

  • Novartis Investigative Site

    Monterrey, 64060

  • Novartis Investigative Site

    Oaxaca, Mexico City, 68000

Other trials in Mexico

United Kingdom6 sites

  • Novartis Investigative Site

    Brighton, East Sussex, BN2 5BE

  • Novartis Investigative Site

    Bristol, Bristol, City of, BS10 5NB

  • Novartis Investigative Site

    Leicester, Leicestershire, LE5 4PW

  • Novartis Investigative Site

    London, London, City of, SE5 9RS

  • Novartis Investigative Site

    Nottingham, Nottinghamshire, NG5 1PB

  • Novartis Investigative Site

    Salford, Lancashire, M6 8HD

Other trials in United Kingdom

Malaysia5 sites

  • Novartis Investigative Site

    Kajang, Selangor, 43000

  • Novartis Investigative Site

    Kuala Lumpur, WilayahPersekutuan KualaLumpur, 50586

  • Novartis Investigative Site

    Kuala Lumpur, WilayahPersekutuan KualaLumpur, 59100

  • Novartis Investigative Site

    Kuantan, Pahang, 25100

  • Novartis Investigative Site

    Sibu, Sarawak, 96000

Other trials in Malaysia

Croatia4 sites

  • Novartis Investigative Site

    Biškupec Zelinski, 10380

  • Novartis Investigative Site

    Rijeka, 51000

  • Novartis Investigative Site

    Vinkovci, 32100

  • Novartis Investigative Site

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Turkey (Türkiye)4 sites

  • Novartis Investigative Site

    Antalya, 07070

  • Novartis Investigative Site

    Bornova, İzmir, 35100

  • Novartis Investigative Site

    İzmit, Kocaeli, 41380

  • Novartis Investigative Site

    Kayseri, 38039

Other trials in Turkey (Türkiye)

Czechia1 site

  • Novartis Investigative Site

    Prague, Praha, Hlavní Mesto, 128 08

Other trials in Czechia

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)

Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy

Read the detailed description

Approximately 330 participants with eGFR ≥ 30 mL/min/1.73m^2 and with biopsy-proven IgAN will be randomized to receive 600 mg Q2W BION-1301, Novartis FUB523, or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 participants (10 participants per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to < 30 mL/min/1.73 m^2. The exploratory cohort will be randomized using the same schema as the primary cohort.

The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on eGFR as measured by the change from Baseline in eGFR.

Following completion of the 104-week treatment period, subjects may be eligible to enroll in an open-label extension (OLE) study to receive open-label treatment with BION-1301 under a separate protocol. Subjects who do not enroll in the OLE will enter the protocol-specified 24-week safety follow-up period.

To facilitate study participation over this time period, other visits may be remote (away from study site) for participants who elect to self-administer the study drug.

Being tested
BION-1301, Placebo
Keywords
Kidney Diseases, Kidney Diseases, Chronic, Urological Diseases, Glomerulonephritis, Glomerular Disease, Glomerulonephritis, IGA, Glomerulopathy, Immunoglobulin Disease
Medical subject headings
Glomerulonephritis, IGA, Kidney Diseases, Renal Insufficiency, Chronic, Urologic Diseases, Glomerulonephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BION-1301Drug

    Also called Zigakibart, FUB523

    BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks.

  • PlaceboDrug

    Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks.

Study groups in NCT05852938
Study groupRoleWhat they receive
BION-1301Experimental600mg subcutaneous administration every 2 weeks for 104 weeks
Receives: Drug: BION-1301
PlaceboPlacebo comparatorsubcutaneous administration every 2 weeks for 104 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in eGFR

    Change from Baseline to Week 104 in eGFR using the CKD-EPI 2021 creatinine equation

    Measured: Baseline and 104 weeks or approximately 2 years

Secondary outcomes (5)

  1. Change in proteinuria (natural log UPCR)

    Change in urine protein: creatinine ratio (UPCR) from baseline to week 40

    Measured: Baseline and 40 weeks or approximately 9 months

  2. Annualized rate of change in eGFR

    Annualized eGFR slope estimated over 104 weeks using the CKD-EPI 2021 creatinine equation

    Measured: 104 weeks or approximately 2 years

  3. Effect of BION-1301 on specific clinical composite endpoints (30% eGFR reduction)

    Percent of participants meeting the composite endpoint of experiencing at least 1 of the following during the study:

    • At least 30% reduction in eGFR sustained for at least 30 days
    • eGFR < 15 mL/min/1.73m^2, sustained for at least 30 days
    • Chronic dialysis, ≥ 30 days
    • Kidney transplantation
    • All-cause mortality

    Measured: Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104

  4. Effect of BION-1301 on specific clinical composite endpoints (40% eGFR reduction)

    Percent of participants meeting the composite endpoint of experiencing at least 1 of the following during the study:

    • At least 40% reduction in eGFR sustained for at least 30 days
    • eGFR < 15 mL/min/1.73m^2, sustained for at least 30 days
    • Chronic dialysis, ≥ 30 days
    • Kidney transplantation
    • All-cause mortality

    Measured: Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104

  5. Percent Change in Proteinuria and Total Urine Protein

    Percent of participants achieving reduction of proteinuria to < 1.0 g/day at Week 40 and a ≥ 25% decrease in total urine protein from Baseline

    Measured: 40 weeks or approximately 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2023
  2. Study start6 Jul 2023
  3. Primary completion10 Aug 2027 (estimated)
  4. Study completion25 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
383 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05852938
Sponsor's protocol ID
CFUB523A12301
Other IDs
CHK02-02
Status last verified
Mar 2026
First submitted
2 May 2023
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Dulos J, Kreijtz J, Vink P, Cotton V, Kuo JJ, Lo J, Jansen W, Bakker J, Driessen L, Guadagnoli M, van Zandvoort P, Warncke M, Medema JP, Barratt J, van Eenennaam H, Van Elsas A. Zigakibart Potently Inhibits A Proliferation-Inducing Ligand-Mediated IgA Production, Addressing IgAN Pathogenesis Root Causes. Kidney Int Rep. 2026 Apr 6;11(6):106516. doi: 10.1016/j.ekir.2026.106516. eCollection 2026 Jun.

    PubMed 42205925

  • Kooienga L, Lo J, Lee EY, Kim SG, Thomas H, Workeneh B, Agha I, Song Y, Smith W, van Eenennaam H, Van Elsas A, Dulos J, Barratt J. Zigakibart demonstrates clinical safety and efficacy in a Phase 1/2 trial of healthy volunteers and patients with IgA nephropathy. Kidney Int. 2025 Sep;108(3):445-454. doi: 10.1016/j.kint.2025.05.006. Epub 2025 Jun 5.

    PubMed 40482854

  • Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.

    PubMed 40465397

  • Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

    PubMed 38299639

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BION-1301 in people with IgA Nephropathy and Immunoglobulin A Nephropathy, run by Novartis Pharmaceuticals at 200 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 200 sites in United States, China, Japan, India, South Korea and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in eGFR (time frame: Baseline and 104 weeks or approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05852938, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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