A Study of Zigakibart in Adults With IgA Nephropathy

NCT05852938 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CFUB523A12301CHK02-02
• Study Type: interventional
• Target: 383
• Locations: 23 countries
• Sites: 200

Brief Summary

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

Conditions

IgA Nephropathy; Immunoglobulin A Nephropathy

Keywords

Kidney Diseases; Kidney Diseases, Chronic; Urological Diseases; Glomerulonephritis; Glomerular Disease; Glomerulonephritis, IGA; Glomerulopathy; Immunoglobulin Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in proteinuria (natural log UPCR)

  Baseline and 40 weeks or approximately 9 months

• Annualized rate of change in eGFR

  104 weeks or approximately 2 years

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

  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)

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

• Percent Change in Proteinuria and Total Urine Protein

  40 weeks or approximately 9 months

Study Arms (2)

BION-1301

EXPERIMENTAL

600mg subcutaneous administration every 2 weeks for 104 weeks

Drug: BION-1301

Placebo

PLACEBO COMPARATOR

subcutaneous administration every 2 weeks for 104 weeks

Drug: Placebo

Interventions

BION-1301 DRUG

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

Also known as: Zigakibart, FUB523

BION-1301

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (200)

University of Alabama at Birmingham: The Kirklin Clinic

Birmingham, Alabama, 35233-1926, United States

Location

Nephrology Consultants, LLC

Huntsville, Alabama, 35805-4104, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Valiance Clinical Research

South Gate, California, 90280-5219, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Denver Nephrology Research Division

Denver, Colorado, 80230-6441, United States

Location

Vida Medical Centers - Pembroke Pines

Pembroke Pines, Florida, 33023-2213, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201-1700, United States

Location

Nephrology Associales of Northern Illinois and Indiana

Hinsdale, Illinois, 60521-3640, United States

Location

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

Fort Wayne, Indiana, 46804, United States

Location

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, 52242-1009, United States

Location

Intermed Consultants

Edina, Minnesota, 55435-2129, United States

Location

Capital District Renal Physicians

Clifton Park, New York, 12065, United States

Location

Nephrology Associates PC - Flushing

Flushing, New York, 11355-5045, United States

Location

Icahn School of Medicine at Mount Sinai

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

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University of Cincinnati College of Medicine - 231 Albert Sabin Way

Cincinnati, Ohio, 45267-2827, United States

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Cleveland Clinic-9500 Euclid Ave

Cleveland, Ohio, 44109-1900, United States

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OHSU - Oregon Clinical and Translational Research Institute

Portland, Oregon, 97239, United States

Location

Northeast Clinical Research Center, LLC

Bethlehem, Pennsylvania, 18017-2159, United States

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Columbia Nephrology Associates , P.A. - Columbia

Columbia, South Carolina, 29203-6476, United States

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Knoxville Kidney Center, PLLC - Frenova F1

Knoxville, Tennessee, 37923, United States

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Dallas Renal Group - 1411 N Beckley Ave

Dallas, Texas, 75230, United States

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

Dallas, Texas, 75237-3461, United States

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DaVita Clinical Research

El Paso, Texas, 79925, United States

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University of Texas MD Anderson Cancer Center-1155 Pressler

Houston, Texas, 77030-2348, United States

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East Texas Nephrology Associates

Lufkin, Texas, 75904-3132, United States

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Nephrology Associates of Northern Virginia-8501 Arlington Blvd

Fairfax, Virginia, 22033-1907, United States

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Swedish Center for Comprehensive Care

Seattle, Washington, 98104, United States

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Novartis Investigative Site

La Plata, Buenos Aires, B1902COS, Argentina

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Catamarca, Catamarca Province, K4700, Argentina

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Barracas, Ciudad Autónoma de BuenosAires, C1280AEB, Argentina

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Rosario, Santa Fe Province, S2013DTC, Argentina

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Santa Fe, Santa Fe Province, S3000EPV, Argentina

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Buenos Aires, C1425, Argentina

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Gosford, New South Wales, 2250, Australia

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Kogarah, New South Wales, 2217, Australia

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Liverpool, New South Wales, 2170, Australia

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Penrith, New South Wales, 2750, Australia

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St Leonards, New South Wales, 2065, Australia

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Cairns North, Queensland, 4870, Australia

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Box Hill, Victoria, 3128, Australia

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St Albans, Victoria, 3021, Australia

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Bonheiden, Antwerpen, 2820, Belgium

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Ghent, Oost-Vlaanderen, 9000, Belgium

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Roeselare, West-Vlaanderen, 8800, Belgium

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Liège, Liège, Belgium

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Lodelinsart, 6042, Belgium

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Woluwe-Saint-Lambert, 1200, Belgium

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Santana, Amapá, 68925-000, Brazil

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Belo Horizonte, Minas Gerais, 30130-100, Brazil

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Maringá, Paraná, 87013-040, Brazil

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

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Joinville, Santa Catarina, 89227-680, Brazil

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

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São Paulo, São Paulo, 01323-001, Brazil

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São Paulo, 04023-900, Brazil

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Vancouver, British Columbia, V5Z 1M9, Canada

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Brampton, Ontario, L6Z 4N5, Canada

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East York, Ontario, M4C 5T2, Canada

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London, Ontario, N6A 5A5, Canada

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Toronto, Ontario, M5G 2N2, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Hefei, Anhui, 230601, China

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Beijing, Beijing Municipality, 100034, China

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Foshan, Guangdong, 528000, China

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Guangzhou, Guangdong, 510080, China

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Guangzhou, Guangdong, 510280, China

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Shenzhen, Guangdong, 518036, China

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Nanning, Guangxi, 530021, China

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Guiyang, Guizhou, 550002, China

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Wuhan, Hubei, 430060, China

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Nanjing, Jiangsu, 210029, China

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Nantong, Jiangsu, 226001, China

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Wuxi, Jiangsu, 214023, China

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Nanchang, Jiangxi, 330006, China

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Jinan, Shandong, 250021, China

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Qingdao, Shandong, 266005, China

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Shanghai, Shanghai Municipality, 200040, China

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Taiyuan, Shanxi, 030001, China

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Taiyuan, Shanxi, 650000, China

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Chengdu, Sichuan, 610072, China

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Ürümqi, Xinjiang, 830001, China

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Wulumuji, Xinjiang, 830054, China

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Hangzhou, Zhejiang, 310009, China

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Taizhou, Zhejiang, 317000, China

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Zagreb, City of Zagreb, 10000, Croatia

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Biškupec Zelinski, 10380, Croatia

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Rijeka, 51000, Croatia

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Vinkovci, 32100, Croatia

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Prague, Praha, Hlavní Mesto, 128 08, Czechia

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Nîmes, Gard, 30029, France

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Lille, Nord, 59000, France

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Lyon, Rhône, 69437, France

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Grenoble, 38043, France

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Paris, 75010, France

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Paris, 75015, France

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Augsburg, Bavaria, 86156, Germany

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Hanover, Lower Saxony, 30459, Germany

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Hanover, Lower Saxony, 30625, Germany

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Mainz, Rhineland-Palatinate, 55131, Germany

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Trier, Rhineland-Palatinate, 54292, Germany

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Magdeburg, Saxony-Anhalt, 39120, Germany

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Jena, Thuringia, 07747, Germany

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Essen, 45147, Germany

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Pátrai, Achaïa, 265 04, Greece

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Athens, Attica, 12462, Greece

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Kalamaria, Thessaloniki, 551 34, Greece

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Heralkion, 71409, Greece

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Ioannina, 450 01, Greece

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Ioannina, 455 00, Greece

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Thessaloniki, 546 29, Greece

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Hyderabad, Andhra Pradesh, 500084, India

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Chandigarh, Chandigarh, 160012, India

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Faridabad, Haryana, 121002, India

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Bengaluru, Karnataka, 560004, India

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Trivandrum, Kerala, 695011, India

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Jaipur, Rajasthan, 302001, India

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Jaipur, Rajasthan, 302017, India

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Vellore, Tamil Nadu, 632004, India

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Lucknow, Uttar Pradesh, 226005, India

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Kolkata, West Bengal, 700014, India

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Dehradun, 248001, India

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Beersheba, Southern District, 84101, Israel

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Holon, Tel Aviv, 58000, Israel

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Ramat Gan, Tel Aviv, 52394, Israel

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Be’er Ya‘aqov, 70300, Israel

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Ramat Gan, 5262100, Israel

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Tel Aviv, 64239, Israel

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Bari, Apulia, 70124, Italy

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Foggia, Apulia, 71100, Italy

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Naples, Campania, 80131, Italy

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Modena, Emilia-Romagna, 41124, Italy

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Trieste, Friuli Venezia Giulia, 34149, Italy

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Pavia, Lombardy, 27100, Italy

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Ranica, Lombardy, 24020, Italy

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Kasugai-Shi, Aiti, 486-0804, Japan

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Toyoake-shi, Aiti, 470-1192, Japan

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Urayasu-Shi, Chiba, 279-0021, Japan

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Sapporo, Hokkaidô, 060-8604, Japan

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Kitakyushu, Hukuoka, 802-8555, Japan

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Yokohama, Kanagawa, 236-0004, Japan

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Kashihara, Nara, 634-8522, Japan

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Nara, Nara, 630-8581, Japan

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Osaka, Osaka, 558-0056, Japan

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Bunkyo-Ku, Tokyo, 113-8431, Japan

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Hachioji-Shi, Tokyo, 192-0071, Japan

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Minato-Ku, Tokyo, 105-8471, Japan

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Shinjuku-Ku, Tokyo, 162-0054, Japan

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Chiba, 260-8712, Japan

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Niigata, 951-8520, Japan

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Okayama, 700-8558, Japan

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Tokyo, 105-8470, Japan

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Yufu-Shi, Ôita, 879-5503, Japan

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Kuantan, Pahang, 25100, Malaysia

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Sibu, Sarawak, 96000, Malaysia

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Kajang, Selangor, 43000, Malaysia

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Kuala Lumpur, WilayahPersekutuan KualaLumpur, 50586, Malaysia

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Kuala Lumpur, WilayahPersekutuan KualaLumpur, 59100, Malaysia

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Chihuahua, Chiapas, 31217, Mexico

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Barrio Belisario Domínguez Secc, Mexico City, 14080, Mexico

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Oaxaca, Mexico City, 68000, Mexico

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Aguascalientes, 20259, Mexico

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Chihuahua City, 64060, Mexico

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Monterrey, 64060, Mexico

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

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Guri-si, Gyeonggido, South Korea

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Uijeongbu-si, Gyeonggido, 11765, South Korea

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Jongno-gu, Seoul Teugbyeolsi, 03080, South Korea

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Seodaemun-gu, Seoul Teugbyeolsi, 03722, South Korea

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Seongbuk-Gu, Seoul Teugbyeolsi, 02841, South Korea

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Cheonan, South Korea

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Daejeon, 301721, South Korea

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Seoul, 06973, South Korea

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Manises, Valencia, 46940, Spain

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Barcelona, 8035, Spain

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Girona, 17007, Spain

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Lleida, 25198, Spain

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Lugo, 27880, Spain

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Madrid, 28007, Spain

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Madrid, 28041, Spain

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Seville, 41009, Spain

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Keelung, Keelung, 204, Taiwan

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Changhua County, 50006, Taiwan

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Hsinchu, Taiwan

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Hualien City, 970, Taiwan

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Kaohsiung City, Taiwan

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Tainan, 704, Taiwan

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Taipei, 100, Taiwan

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Taipei, 116, Taiwan

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Bornova, İzmir, 35100, Turkey (Türkiye)

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İzmit, Kocaeli, 41380, Turkey (Türkiye)

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Antalya, 07070, Turkey (Türkiye)

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Kayseri, 38039, Turkey (Türkiye)

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

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Brighton, East Sussex, BN2 5BE, United Kingdom

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Salford, Lancashire, M6 8HD, United Kingdom

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Leicester, Leicestershire, LE5 4PW, United Kingdom

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

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Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

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Related Publications (3)

• 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.

  PMID: 40482854 DERIVED

• 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.

  PMID: 40465397 DERIVED

• 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.

  PMID: 38299639 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA; Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Glomerulonephritis

Condition Hierarchy (Ancestors)

Nephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: July 6, 2023
• Primary Completion (Estimated): August 10, 2027
• Study Completion (Estimated): January 25, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

AU (8); AR (6); BE (6); FR (6); CN (23); IL (6); JP (18); TU (4); CA (7); DE (8); IT (7); KR (9); CZ (1); TW (8); MY (5); ME (6); BR (8); CR (4); IN (11); ES (8); GR (7); US (28); GB (6)