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

Status: Active_not_recruiting
Location: See all (199) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Screening weight of 45 to 150 kg.

• Men and women of childbearing potential (WOCBP; per Clinical Trials Facilitation and Coordination Group \[CTFG\] 2020) must agree to follow protocol-specified contraception guidance from Screening through approximately 5 half-lives (24 weeks) after the final dose of study drug. Use of hormonal contraceptive agents must have been initiated \> 1 month prior to first dose of study drug.

• Provide written informed consent and be willing to comply with study visits and procedures.

Locations
United States
Alabama
University of Alabama at Birmingham: The Kirklin Clinic
Birmingham
Nephrology Consultants, LLC
Huntsville
California
University of California, San Francisco
San Francisco
Valiance Clinical Research
South Gate
Colorado
University of Colorado Hospital
Aurora
Denver Nephrology Research Division
Denver
Florida
Vida Medical Centers - Pembroke Pines
Pembroke Pines
Iowa
University Of Iowa Hospitals And Clinics
Iowa City
Illinois
NorthShore University HealthSystem
Evanston
Nephrology Associales of Northern Illinois and Indiana
Hinsdale
Indiana
Nephrology Associates of Northern Illinois and Indiana - 7836 W Jefferson Blvd
Fort Wayne
Minnesota
Intermed Consultants
Edina
New York
Capital District Renal Physicians
Clifton Park
Nephrology Associates PC - Flushing
Flushing
Icahn School of Medicine at Mount Sinai
New York
Ohio
University of Cincinnati College of Medicine - 231 Albert Sabin Way
Cincinnati
Cleveland Clinic-9500 Euclid Ave
Cleveland
Oregon
OHSU - Oregon Clinical and Translational Research Institute
Portland
Pennsylvania
Northeast Clinical Research Center, LLC
Bethlehem
South Carolina
Columbia Nephrology Associates , P.A. - Columbia
Columbia
Tennessee
Knoxville Kidney Center, PLLC - Frenova F1
Knoxville
Texas
Dallas Renal Group - 1411 N Beckley Ave
Dallas
Dallas Renal Group - Waxachie - 2460 N. I-35
Dallas
DaVita Clinical Research
El Paso
University of Texas MD Anderson Cancer Center-1155 Pressler
Houston
East Texas Nephrology Associates
Lufkin
Virginia
Nephrology Associates of Northern Virginia-8501 Arlington Blvd
Fairfax
Washington
Swedish Center for Comprehensive Care
Seattle
Other Locations
Argentina
Novartis Investigative Site
Barracas
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Buenos Aires
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Catamarca
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La Plata
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Rosario
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Santa Fe
Australia
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Box Hill
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Cairns North
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Gosford
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Kogarah
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Liverpool
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Penrith
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St Albans
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St Leonards
Belgium
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Bonheiden
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Ghent
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Liège
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Lodelinsart
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Roeselare
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Woluwe-saint-lambert
Brazil
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Belo Horizonte
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Joinville
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Maringá
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Porto Alegre
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Santana
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São Bernardo Do Campo
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São Paulo
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São Paulo
Canada
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Brampton
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East York
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Greenfield Park
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London
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Montreal
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Toronto
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Vancouver
China
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Beijing
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Chengdu
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Foshan
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Guangzhou
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Guangzhou
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Guiyang
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Hangzhou
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Hefei
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Jinan
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Nanchang
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Nanjing
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Nanning
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Nantong
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Qingdao
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Shanghai
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Shenzhen
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Taiyuan
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Taiyuan
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Taizhou
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Ürümqi
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Wuhan
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Wulumuji
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Wuxi
Croatia
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Biškupec Zelinski
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Rijeka
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Vinkovci
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Zagreb
France
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Grenoble
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Lille
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Lyon
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Nîmes
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Paris
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Paris
Germany
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Augsburg
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Essen
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Hanover
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Hanover
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Jena
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Magdeburg
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Mainz
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Trier
Greece
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Athens
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Heralkion
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Ioannina
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Ioannina
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Kalamaria
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Pátrai
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Thessaloniki
India
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Bengaluru
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Chandigarh
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Dehradun
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Faridabad
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Hyderabad
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Jaipur
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Jaipur
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Kolkata
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Lucknow
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Trivandrum
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Vellore
Israel
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Be’er Ya‘aqov
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Beersheba
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Holon
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Ramat Gan
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Ramat Gan
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Tel Aviv
Italy
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Bari
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Foggia
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Modena
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Napoli
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Pavia
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Ranica
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Trieste
Japan
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Bunkyo-ku
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Chiba
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Hachioji-shi
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Kashihara
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Kasugai-shi
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Kitakyushu
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Minato-ku
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Nara
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Niigata
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Okayama
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Osaka
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Sapporo
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Shinjuku-ku
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Tokyo
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Toyoake-shi
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Urayasu-shi
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Yokohama
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Yufu-shi
Malaysia
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Kajang
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Kuala Lumpur
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Kuala Lumpur
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Kuantan
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Sibu
Mexico
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Aguascalientes
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Barrio Belisario Domínguez Secc
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Chihuahua
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Chihuahua City
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Monterrey
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Oaxaca
Republic of Korea
Novartis Investigative Site
Cheonan
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Daejeon
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Dongan-gu, Anyang-si
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Guri-si
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Jongno-gu
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Seodaemun-gu
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Seongbuk-gu
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Seoul
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Uijeongbu-si
Spain
Novartis Investigative Site
Barcelona
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Girona
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Lleida
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Lugo
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Madrid
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Madrid
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Manises
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Seville
Taiwan
Novartis Investigative Site
Changhua County
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Hsinchu
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Hualien City
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Kaohsiung City
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Keelung
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Tainan City
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Taipei
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Taipei
Turkey
Novartis Investigative Site
Antalya
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Bornova
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İzmit
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Kayseri
United Kingdom
Novartis Investigative Site
Brighton
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Bristol
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Leicester
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London
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Nottingham
Novartis Investigative Site
Salford
Time Frame
Start Date: 2023-07-06
Completion Date: 2028-06-07
Participants
Target number of participants: 383
Treatments
Experimental: BION-1301
600mg subcutaneous administration every 2 weeks for 104 weeks
Placebo_comparator: Placebo
subcutaneous administration every 2 weeks for 104 weeks
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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