A Study of Zigakibart in Adults With IgA Nephropathy

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

Study Overview

• Status: Active, not recruiting
• Conditions: Immunoglobulin A Nephropathy; IgA Nephropathy
• Intervention / Treatment: Drug: BION-1301; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 383
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425
    • Novartis Investigative Site
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, B1902COS
      • Novartis Investigative Site
  • Catamarca Province
    • Catamarca, Catamarca Province, Argentina, K4700
      • Novartis Investigative Site
  • Ciudad Autónoma de BuenosAires
    • Barracas, Ciudad Autónoma de BuenosAires, Argentina, C1280AEB
      • Novartis Investigative Site
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2013DTC
      • Novartis Investigative Site
    • Santa Fe, Santa Fe Province, Argentina, S3000EPV
      • Novartis Investigative Site
• Australia
  • New South Wales
    • Gosford, New South Wales, Australia, 2250
      • Novartis Investigative Site
    • Kogarah, New South Wales, Australia, 2217
      • Novartis Investigative Site
    • Liverpool, New South Wales, Australia, 2170
      • Novartis Investigative Site
    • Penrith, New South Wales, Australia, 2750
      • Novartis Investigative Site
    • St Leonards, New South Wales, Australia, 2065
      • Novartis Investigative Site
  • Queensland
    • Cairns North, Queensland, Australia, 4870
      • Novartis Investigative Site
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Novartis Investigative Site
    • St Albans, Victoria, Australia, 3021
      • Novartis Investigative Site
• Belgium
  • Liège, Belgium, Liège
    • Novartis Investigative Site
  • Lodelinsart, Belgium, 6042
    • Novartis Investigative Site
  • Woluwe-Saint-Lambert, Belgium, 1200
    • Novartis Investigative Site
  • Antwerpen
    • Bonheiden, Antwerpen, Belgium, 2820
      • Novartis Investigative Site
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • Novartis Investigative Site
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • Novartis Investigative Site
• Brazil
  • São Paulo, Brazil, 04023-900
    • Novartis Investigative Site
  • Amapá
    • Santana, Amapá, Brazil, 68925-000
      • Novartis Investigative Site
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Novartis Investigative Site
  • Paraná
    • Maringá, Paraná, Brazil, 87013-040
      • Novartis Investigative Site
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
      • Novartis Investigative Site
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89227-680
      • Novartis Investigative Site
  • São Paulo
    • São Bernardo do Campo, São Paulo, Brazil, 09780-000
      • Novartis Investigative Site
    • São Paulo, São Paulo, Brazil, 01323-001
      • Novartis Investigative Site
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Novartis Investigative Site
  • Ontario
    • Brampton, Ontario, Canada, L6Z 4N5
      • Novartis Investigative Site
    • East York, Ontario, Canada, M4C 5T2
      • Novartis Investigative Site
    • London, Ontario, Canada, N6A 5A5
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M5G 2N2
      • Novartis Investigative Site
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H1T 2M4
      • Novartis Investigative Site
• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • Novartis Investigative Site
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Novartis Investigative Site
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Novartis Investigative Site
    • Guangzhou, Guangdong, China, 510080
      • Novartis Investigative Site
    • Guangzhou, Guangdong, China, 510280
      • Novartis Investigative Site
    • Shenzhen, Guangdong, China, 518036
      • Novartis Investigative Site
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Novartis Investigative Site
  • Guizhou
    • Guiyang, Guizhou, China, 550002
      • Novartis Investigative Site
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Novartis Investigative Site
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Novartis Investigative Site
    • Nantong, Jiangsu, China, 226001
      • Novartis Investigative Site
    • Wuxi, Jiangsu, China, 214023
      • Novartis Investigative Site
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Novartis Investigative Site
  • Shandong
    • Jinan, Shandong, China, 250021
      • Novartis Investigative Site
    • Qingdao, Shandong, China, 266005
      • Novartis Investigative Site
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Novartis Investigative Site
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Novartis Investigative Site
    • Taiyuan, Shanxi, China, 650000
      • Novartis Investigative Site
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Novartis Investigative Site
  • Xinjiang
    • Wulumuji, Xinjiang, China, 830054
      • Novartis Investigative Site
    • Ürümqi, Xinjiang, China, 830001
      • Novartis Investigative Site
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Novartis Investigative Site
    • Taizhou, Zhejiang, China, 317000
      • Novartis Investigative Site
• Croatia
  • Biškupec Zelinski, Croatia, 10380
    • Novartis Investigative Site
  • Rijeka, Croatia, 51000
    • Novartis Investigative Site
  • Vinkovci, Croatia, 32100
    • Novartis Investigative Site
  • City of Zagreb
    • Zagreb, City of Zagreb, Croatia, 10000
      • Novartis Investigative Site
• Czechia
  • Praha, Hlavní Mesto
    • Prague, Praha, Hlavní Mesto, Czechia, 128 08
      • Novartis Investigative Site
• France
  • Grenoble, France, 38043
    • Novartis Investigative Site
  • Paris, France, 75015
    • Novartis Investigative Site
  • Paris, France, 75010
    • Novartis Investigative Site
  • Gard
    • Nîmes, Gard, France, 30029
      • Novartis Investigative Site
  • Nord
    • Lille, Nord, France, 59000
      • Novartis Investigative Site
  • Rhône
    • Lyon, Rhône, France, 69437
      • Novartis Investigative Site
• Germany
  • Essen, Germany, 45147
    • Novartis Investigative Site
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Novartis Investigative Site
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30459
      • Novartis Investigative Site
    • Hanover, Lower Saxony, Germany, 30625
      • Novartis Investigative Site
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Novartis Investigative Site
    • Trier, Rhineland-Palatinate, Germany, 54292
      • Novartis Investigative Site
  • Saxony-Anhalt
    • Magdeburg, Saxony-Anhalt, Germany, 39120
      • Novartis Investigative Site
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • Novartis Investigative Site
• Greece
  • Heralkion, Greece, 71409
    • Novartis Investigative Site
  • Ioannina, Greece, 450 01
    • Novartis Investigative Site
  • Ioannina, Greece, 455 00
    • Novartis Investigative Site
  • Thessaloniki, Greece, 546 29
    • Novartis Investigative Site
  • Achaïa
    • Pátrai, Achaïa, Greece, 265 04
      • Novartis Investigative Site
  • Attica
    • Athens, Attica, Greece, 12462
      • Novartis Investigative Site
  • Thessaloniki
    • Kalamaria, Thessaloniki, Greece, 551 34
      • Novartis Investigative Site
• India
  • Dehradun, India, 248001
    • Novartis Investigative Site
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500084
      • Novartis Investigative Site
  • Chandigarh
    • Chandigarh, Chandigarh, India, 160012
      • Novartis Investigative Site
  • Haryana
    • Faridabad, Haryana, India, 121002
      • Novartis Investigative Site
  • Karnataka
    • Bengaluru, Karnataka, India, 560004
      • Novartis Investigative Site
  • Kerala
    • Trivandrum, Kerala, India, 695011
      • Novartis Investigative Site
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • Novartis Investigative Site
    • Jaipur, Rajasthan, India, 302001
      • Novartis Investigative Site
  • Tamil Nadu
    • Vellore, Tamil Nadu, India, 632004
      • Novartis Investigative Site
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226005
      • Novartis Investigative Site
  • West Bengal
    • Kolkata, West Bengal, India, 700014
      • Novartis Investigative Site
• Israel
  • Be’er Ya‘aqov, Israel, 70300
    • Novartis Investigative Site
  • Ramat Gan, Israel, 5262100
    • Novartis Investigative Site
  • Tel Aviv, Israel, 64239
    • Novartis Investigative Site
  • Southern District
    • Beersheba, Southern District, Israel, 84101
      • Novartis Investigative Site
  • Tel Aviv
    • Holon, Tel Aviv, Israel, 58000
      • Novartis Investigative Site
    • Ramat Gan, Tel Aviv, Israel, 52394
      • Novartis Investigative Site
• Italy
  • Apulia
    • Bari, Apulia, Italy, 70124
      • Novartis Investigative Site
    • Foggia, Apulia, Italy, 71100
      • Novartis Investigative Site
  • Campania
    • Naples, Campania, Italy, 80131
      • Novartis Investigative Site
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41124
      • Novartis Investigative Site
  • Friuli Venezia Giulia
    • Trieste, Friuli Venezia Giulia, Italy, 34149
      • Novartis Investigative Site
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Novartis Investigative Site
    • Ranica, Lombardy, Italy, 24020
      • Novartis Investigative Site
• Japan
  • Chiba, Japan, 260-8712
    • Novartis Investigative Site
  • Niigata, Japan, 951-8520
    • Novartis Investigative Site
  • Okayama, Japan, 700-8558
    • Novartis Investigative Site
  • Tokyo, Japan, 105-8470
    • Novartis Investigative Site
  • Aiti
    • Kasugai-Shi, Aiti, Japan, 486-0804
      • Novartis Investigative Site
    • Toyoake-shi, Aiti, Japan, 470-1192
      • Novartis Investigative Site
  • Chiba
    • Urayasu-Shi, Chiba, Japan, 279-0021
      • Novartis Investigative Site
  • Hokkaidô
    • Sapporo, Hokkaidô, Japan, 060-8604
      • Novartis Investigative Site
  • Hukuoka
    • Kitakyushu, Hukuoka, Japan, 802-8555
      • Novartis Investigative Site
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0004
      • Novartis Investigative Site
  • Nara
    • Kashihara, Nara, Japan, 634-8522
      • Novartis Investigative Site
    • Nara, Nara, Japan, 630-8581
      • Novartis Investigative Site
  • Osaka
    • Osaka, Osaka, Japan, 558-0056
      • Novartis Investigative Site
  • Tokyo
    • Bunkyo-Ku, Tokyo, Japan, 113-8431
      • Novartis Investigative Site
    • Hachioji-Shi, Tokyo, Japan, 192-0071
      • Novartis Investigative Site
    • Minato-Ku, Tokyo, Japan, 105-8471
      • Novartis Investigative Site
    • Shinjuku-Ku, Tokyo, Japan, 162-0054
      • Novartis Investigative Site
  • Ôita
    • Yufu-Shi, Ôita, Japan, 879-5503
      • Novartis Investigative Site
• Malaysia
  • Pahang
    • Kuantan, Pahang, Malaysia, 25100
      • Novartis Investigative Site
  • Sarawak
    • Sibu, Sarawak, Malaysia, 96000
      • Novartis Investigative Site
  • Selangor
    • Kajang, Selangor, Malaysia, 43000
      • Novartis Investigative Site
  • WilayahPersekutuan KualaLumpur
    • Kuala Lumpur, WilayahPersekutuan KualaLumpur, Malaysia, 50586
      • Novartis Investigative Site
    • Kuala Lumpur, WilayahPersekutuan KualaLumpur, Malaysia, 59100
      • Novartis Investigative Site
• Mexico
  • Aguascalientes, Mexico, 20259
    • Novartis Investigative Site
  • Chihuahua City, Mexico, 64060
    • Novartis Investigative Site
  • Monterrey, Mexico, 64060
    • Novartis Investigative Site
  • Chiapas
    • Chihuahua, Chiapas, Mexico, 31217
      • Novartis Investigative Site
  • Mexico City
    • Barrio Belisario Domínguez Secc, Mexico City, Mexico, 14080
      • Novartis Investigative Site
    • Oaxaca, Mexico City, Mexico, 68000
      • Novartis Investigative Site
• South Korea
  • Cheonan, South Korea
    • Novartis Investigative Site
  • Daejeon, South Korea, 301721
    • Novartis Investigative Site
  • Seoul, South Korea, 06973
    • Novartis Investigative Site
  • Gyeonggido
    • Dongan-Gu, Anyang-Si, Gyeonggido, South Korea, 14068
      • Novartis Investigative Site
    • Guri-si, Gyeonggido, South Korea
      • Novartis Investigative Site
    • Uijeongbu-si, Gyeonggido, South Korea, 11765
      • Novartis Investigative Site
  • Seoul Teugbyeolsi
    • Jongno-gu, Seoul Teugbyeolsi, South Korea, 03080
      • Novartis Investigative Site
    • Seodaemun-gu, Seoul Teugbyeolsi, South Korea, 03722
      • Novartis Investigative Site
    • Seongbuk-Gu, Seoul Teugbyeolsi, South Korea, 02841
      • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 8035
    • Novartis Investigative Site
  • Girona, Spain, 17007
    • Novartis Investigative Site
  • Lleida, Spain, 25198
    • Novartis Investigative Site
  • Lugo, Spain, 27880
    • Novartis Investigative Site
  • Madrid, Spain, 28041
    • Novartis Investigative Site
  • Madrid, Spain, 28007
    • Novartis Investigative Site
  • Seville, Spain, 41009
    • Novartis Investigative Site
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Novartis Investigative Site
• Taiwan
  • Changhua County, Taiwan, 50006
    • Novartis Investigative Site
  • Hsinchu, Taiwan
    • Novartis Investigative Site
  • Hualien City, Taiwan, 970
    • Novartis Investigative Site
  • Kaohsiung City, Taiwan
    • Novartis Investigative Site
  • Tainan, Taiwan, 704
    • Novartis Investigative Site
  • Taipei, Taiwan, 100
    • Novartis Investigative Site
  • Taipei, Taiwan, 116
    • Novartis Investigative Site
  • Keelung
    • Keelung, Keelung, Taiwan, 204
      • Novartis Investigative Site
• Turkey (Türkiye)
  • Antalya, Turkey (Türkiye), 07070
    • Novartis Investigative Site
  • Kayseri, Turkey (Türkiye), 38039
    • Novartis Investigative Site
  • Kocaeli
    • İzmit, Kocaeli, Turkey (Türkiye), 41380
      • Novartis Investigative Site
  • İzmir
    • Bornova, İzmir, Turkey (Türkiye), 35100
      • Novartis Investigative Site
• United Kingdom
  • Bristol, City of
    • Bristol, Bristol, City of, United Kingdom, BS10 5NB
      • Novartis Investigative Site
  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN2 5BE
      • Novartis Investigative Site
  • Lancashire
    • Salford, Lancashire, United Kingdom, M6 8HD
      • Novartis Investigative Site
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE5 4PW
      • Novartis Investigative Site
  • London, City of
    • London, London, City of, United Kingdom, SE5 9RS
      • Novartis Investigative Site
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-1926
      • University of Alabama at Birmingham: The Kirklin Clinic
    • Huntsville, Alabama, United States, 35805-4104
      • Nephrology Consultants, LLC
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
    • South Gate, California, United States, 90280-5219
      • Valiance Clinical Research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
    • Denver, Colorado, United States, 80230-6441
      • Denver Nephrology Research Division
  • Florida
    • Pembroke Pines, Florida, United States, 33023-2213
      • Vida Medical Centers - Pembroke Pines
  • Illinois
    • Evanston, Illinois, United States, 60201-1700
      • Northshore University Healthsystem
    • Hinsdale, Illinois, United States, 60521-3640
      • Nephrology Associales of Northern Illinois and Indiana
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Nephrology Associates of Northern Illinois and Indiana - 7836 W Jefferson Blvd
  • Iowa
    • Iowa City, Iowa, United States, 52242-1009
      • University of Iowa Hospitals and Clinics
  • Minnesota
    • Edina, Minnesota, United States, 55435-2129
      • Intermed Consultants
  • New York
    • Clifton Park, New York, United States, 12065
      • Capital District Renal Physicians
    • Flushing, New York, United States, 11355-5045
      • Nephrology Associates PC - Flushing
    • New York, New York, United States, 10029-6504
      • Icahn School of Medicine at Mount Sinai
  • Ohio
    • Cincinnati, Ohio, United States, 45267-2827
      • University of Cincinnati College of Medicine - 231 Albert Sabin Way
    • Cleveland, Ohio, United States, 44109-1900
      • Cleveland Clinic-9500 Euclid Ave
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU - Oregon Clinical and Translational Research Institute
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017-2159
      • Northeast Clinical Research Center, LLC
  • South Carolina
    • Columbia, South Carolina, United States, 29203-6476
      • Columbia Nephrology Associates , P.A. - Columbia
  • Tennessee
    • Knoxville, Tennessee, United States, 37923
      • Knoxville Kidney Center, PLLC - Frenova F1
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Renal Group - 1411 N Beckley Ave
    • Dallas, Texas, United States, 75237-3461
      • Dallas Renal Group - Waxachie - 2460 N. I-35
    • El Paso, Texas, United States, 79925
      • DaVita Clinical Research
    • Houston, Texas, United States, 77030-2348
      • University of Texas MD Anderson Cancer Center-1155 Pressler
    • Lufkin, Texas, United States, 75904-3132
      • East Texas Nephrology Associates
  • Virginia
    • Fairfax, Virginia, United States, 22033-1907
      • Nephrology Associates of Northern Virginia-8501 Arlington Blvd
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Center for Comprehensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BION-1301; 600mg subcutaneous administration every 2 weeks for 104 weeks	Drug: BION-1301; BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks.; Other Names: Zigakibart; FUB523
Placebo Comparator: Placebo; subcutaneous administration every 2 weeks for 104 weeks	Drug: Placebo; Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in eGFR	Change from Baseline to Week 104 in eGFR using the CKD-EPI 2021 creatinine equation	Baseline and 104 weeks or approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104
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	Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104
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	40 weeks or approximately 9 months
Annualized rate of change in eGFR	Annualized eGFR slope estimated over 104 weeks using the CKD-EPI 2021 creatinine equation	104 weeks or approximately 2 years
Change in proteinuria (natural log UPCR)	Change in urine protein: creatinine ratio (UPCR) from baseline to week 40	Baseline and 40 weeks or approximately 9 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Estimated): August 10, 2027
• Study Completion (Estimated): January 25, 2028

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Kidney Diseases; Glomerular Disease; Glomerulonephritis; Urological Diseases; Glomerulonephritis, IGA; Glomerulopathy; Immunoglobulin Disease; Kidney Diseases, Chronic
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Nephritis; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Glomerulonephritis; Kidney Diseases; Renal Insufficiency, Chronic; Glomerulonephritis, IGA; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: CFUB523A12301; CHK02-02 (Other Identifier: Chinook Therapeutics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No