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A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.
Official title: A Multicenter Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan in Adult Participants With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
540
Start Date
2021-09-20
Completion Date
2032-10-25
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
LNP023
Capsule 200 mg (b.i.d.) taken orally twice a day
Locations (161)
AZ Kidney Dise and Hypertension Ctr
Glendale, Arizona, United States
Kaiser Permanente
San Diego, California, United States
North America Research Institute
San Dimas, California, United States
University of Colorado Anschutz
Aurora, Colorado, United States
Nephrology Associates PA
Newark, Delaware, United States
CaRe Research
Chubbuck, Idaho, United States
Nep Assoc of Northern Illinois
Hinsdale, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Clin Rsrch Consult a JCCT Company
Kansas City, Missouri, United States
DaVita Clinical Research
Las Vegas, Nevada, United States
New Jersey Kidney Care
Jersey City, New Jersey, United States
Col Uni Med Center New York Presby
New York, New York, United States
Dallas Renal Group
Dallas, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
Novartis Investigative Site
Córdoba, Córdoba Province, Argentina
Novartis Investigative Site
Córdoba, Córdoba Province, Argentina
Novartis Investigative Site
CABA, Argentina
Novartis Investigative Site
CABA, Argentina
Novartis Investigative Site
Santa Fe, Argentina
Novartis Investigative Site
Woolloongabba, Queensland, Australia
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
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Roeselare, West-Vlaanderen, Belgium
Novartis Investigative Site
Edegem, Belgium
Novartis Investigative Site
Leuven, Belgium
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Belo Horizonte, Minas Gerais, Brazil
Novartis Investigative Site
Curitiba, Paraná, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
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Sao Jose Rio Preto, Brazil
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Oshawa, Ontario, Canada
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Temuco, Chile
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Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
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Guangzhou, Guangdong, China
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Luoyang, Henan, China
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Zhengzhou, Henan, China
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Changsha, Hunan, China
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Changchun, Jilin, China
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Yinchuan, Ningxia, China
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Taiyuan, Shanxi, China
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Xian, Shanxi, China
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Ürümqi, Xinjiang, China
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Ningbo, Zhejiang, China
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Wenzhou, Zhejiang, China
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Beijing, China
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Guangzhou, China
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Ningbo, China
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Qingdao, China
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Shanghai, China
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Shanghai, China
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Shenzhen, China
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Medellín, Antioquia, Colombia
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Barranquilla, Atlántico, Colombia
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Prague, Czechia
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Aalborg, Denmark
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Aarhus N, Denmark
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Copenhagen, Denmark
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Odense C, Denmark
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Marseille, France
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Montpellier, France
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Paris, France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Stuttgart, Baden-Wurttemberg, Germany
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Aachen, Germany
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Berlin, Germany
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Essen, Germany
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Hanover, Germany
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Heidelberg, Germany
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Kiel, Germany
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Magdeburg, Germany
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Mainz, Germany
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Tübingen, Germany
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Ulm, Germany
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Hong Kong, Hong Kong, Hong Kong
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Pécs, Baranya, Hungary
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Debrecen, Hajdu Bihar Megye, Hungary
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Bangalore, Karnataka, India
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New Delhi, National Capital Territory of Delhi, India
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New Delhi, National Capital Territory of Delhi, India
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Hyderabad, Telangana, India
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Ashkelon, Israel
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Jerusalem, Israel
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Petah Tikva, Israel
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Bologna, BO, Italy
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Naples, Italy
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Kasugai, Aichi-ken, Japan
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Toyoake, Aichi-ken, Japan
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Toyota, Aichi-ken, Japan
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Sapporo, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Kawasaki, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokohama, Kanagawa-ku, Japan
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Kyoto, Kyoto, Japan
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Sendai, Miyagi, Japan
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Matsumoto, Nagano, Japan
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Osaka, Osaka, Japan
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Ōmihachiman, Shiga, Japan
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Chiba, Japan
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Niigata, Japan
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Okayama, Japan
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Osaka, Japan
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Osaka, Japan
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Kuala Lumpur, Malaysia
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Mexico City, Mexico
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Querétaro, Mexico
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Groningen, Provincie Groningen, Netherlands
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Nordbyhagen, Oslo County, Norway
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Bergen, Norway
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Singapore, Singapore
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Singapore, Singapore
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Košice, Slovakia
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Maribor, Slovenia, Slovenia
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Ljubljana, Slovenia
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Bloemfontein, Free State, South Africa
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Bundang Gu, Gyeonggi-do, South Korea
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Cheongju-si, North Chungcheong, South Korea
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Busan, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Taegu, South Korea
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Pamplona, Navarre, Spain
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Barcelona, Spain
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Salamanca, Spain
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Stockholm, Sweden
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Kaohsiung City, Taiwan
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New Taipei City, Taiwan
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New Taipei City, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Bangkok, Thailand
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Bangkok, Thailand
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Istanbul, Fatih, Turkey (Türkiye)
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Köseköy, Kocaeli, Turkey (Türkiye)
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Antalya, Konyaalti, Turkey (Türkiye)
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Kayseri, Melikgazi, Turkey (Türkiye)
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Istanbul, Sariyer, Turkey (Türkiye)
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Ankara, Yenimahalle, Turkey (Türkiye)
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Mersin, Yenisehir, Turkey (Türkiye)
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Newcastle upon Tyne, Tyne and Wear, United Kingdom
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Cambridge, United Kingdom
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Leicester, United Kingdom
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London, United Kingdom
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Salford, United Kingdom
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Ho Chi Minh City, VNM, Vietnam
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Ho Chi Minh City, Vietnam