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A Study of Zigakibart in Adults With IgA Nephropathy
Sponsor: Novartis Pharmaceuticals
Summary
Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
383
Start Date
2023-07-06
Completion Date
2028-01-25
Last Updated
2026-04-01
Healthy Volunteers
No
Interventions
BION-1301
BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks.
Placebo
Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks.
Locations (200)
University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama, United States
Nephrology Consultants, LLC
Huntsville, Alabama, United States
University of California, San Francisco
San Francisco, California, United States
Valiance Clinical Research
South Gate, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Denver Nephrology Research Division
Denver, Colorado, United States
Vida Medical Centers - Pembroke Pines
Pembroke Pines, Florida, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Nephrology Associales of Northern Illinois and Indiana
Hinsdale, Illinois, United States
Nephrology Associates of Northern Illinois and Indiana - 7836 W Jefferson Blvd
Fort Wayne, Indiana, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Intermed Consultants
Edina, Minnesota, United States
Capital District Renal Physicians
Clifton Park, New York, United States
Nephrology Associates PC - Flushing
Flushing, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Cincinnati College of Medicine - 231 Albert Sabin Way
Cincinnati, Ohio, United States
Cleveland Clinic-9500 Euclid Ave
Cleveland, Ohio, United States
OHSU - Oregon Clinical and Translational Research Institute
Portland, Oregon, United States
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, United States
Columbia Nephrology Associates , P.A. - Columbia
Columbia, South Carolina, United States
Knoxville Kidney Center, PLLC - Frenova F1
Knoxville, Tennessee, United States
Dallas Renal Group - 1411 N Beckley Ave
Dallas, Texas, United States
Dallas Renal Group - Waxachie - 2460 N. I-35
Dallas, Texas, United States
DaVita Clinical Research
El Paso, Texas, United States
University of Texas MD Anderson Cancer Center-1155 Pressler
Houston, Texas, United States
East Texas Nephrology Associates
Lufkin, Texas, United States
Nephrology Associates of Northern Virginia-8501 Arlington Blvd
Fairfax, Virginia, United States
Swedish Center for Comprehensive Care
Seattle, Washington, United States
Novartis Investigative Site
La Plata, Buenos Aires, Argentina
Novartis Investigative Site
Catamarca, Catamarca Province, Argentina
Novartis Investigative Site
Barracas, Ciudad Autónoma de BuenosAires, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
Santa Fe, Santa Fe Province, Argentina
Novartis Investigative Site
Buenos Aires, Argentina
Novartis Investigative Site
Gosford, New South Wales, Australia
Novartis Investigative Site
Kogarah, New South Wales, Australia
Novartis Investigative Site
Liverpool, New South Wales, Australia
Novartis Investigative Site
Penrith, New South Wales, Australia
Novartis Investigative Site
St Leonards, New South Wales, Australia
Novartis Investigative Site
Cairns North, Queensland, Australia
Novartis Investigative Site
Box Hill, Victoria, Australia
Novartis Investigative Site
St Albans, Victoria, Australia
Novartis Investigative Site
Bonheiden, Antwerpen, Belgium
Novartis Investigative Site
Ghent, Oost-Vlaanderen, Belgium
Novartis Investigative Site
Roeselare, West-Vlaanderen, Belgium
Novartis Investigative Site
Liège, Belgium
Novartis Investigative Site
Lodelinsart, Belgium
Novartis Investigative Site
Woluwe-Saint-Lambert, Belgium
Novartis Investigative Site
Santana, Amapá, Brazil
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
Novartis Investigative Site
Maringá, Paraná, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
Joinville, Santa Catarina, Brazil
Novartis Investigative Site
São Bernardo do Campo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, Brazil
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Brampton, Ontario, Canada
Novartis Investigative Site
East York, Ontario, Canada
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Greenfield Park, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Hefei, Anhui, China
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Foshan, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Shenzhen, Guangdong, China
Novartis Investigative Site
Nanning, Guangxi, China
Novartis Investigative Site
Guiyang, Guizhou, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nantong, Jiangsu, China
Novartis Investigative Site
Wuxi, Jiangsu, China
Novartis Investigative Site
Nanchang, Jiangxi, China
Novartis Investigative Site
Jinan, Shandong, China
Novartis Investigative Site
Qingdao, Shandong, China
Novartis Investigative Site
Shanghai, Shanghai Municipality, China
Novartis Investigative Site
Taiyuan, Shanxi, China
Novartis Investigative Site
Taiyuan, Shanxi, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Ürümqi, Xinjiang, China
Novartis Investigative Site
Wulumuji, Xinjiang, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Taizhou, Zhejiang, China
Novartis Investigative Site
Zagreb, City of Zagreb, Croatia
Novartis Investigative Site
Biškupec Zelinski, Croatia
Novartis Investigative Site
Rijeka, Croatia
Novartis Investigative Site
Vinkovci, Croatia
Novartis Investigative Site
Prague, Praha, Hlavní Mesto, Czechia
Novartis Investigative Site
Nîmes, Gard, France
Novartis Investigative Site
Lille, Nord, France
Novartis Investigative Site
Lyon, Rhône, France
Novartis Investigative Site
Grenoble, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Augsburg, Bavaria, Germany
Novartis Investigative Site
Hanover, Lower Saxony, Germany
Novartis Investigative Site
Hanover, Lower Saxony, Germany