A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

Who is this study for? Adults with active proliferative lupus nephritis
What treatments are being studied? Anifrolumab
Status: Recruiting
Location: See all (234) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification

• Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.

• Urine protein to creatinine ratio \> 1 mg/mg (113.17 mg/mmol)

• eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).

• Fulfills updated 2019 EULAR/ACR SLE classification criteria.

• No signs of symptoms of active TB prior to or during screening or no treatment for latent TB

Locations
United States
Alabama
Research Site
WITHDRAWN
Birmingham
Arizona
Research Site
ACTIVE_NOT_RECRUITING
Glendale
California
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WITHDRAWN
La Jolla
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ACTIVE_NOT_RECRUITING
La Palma
Research Site
WITHDRAWN
Loma Linda
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ACTIVE_NOT_RECRUITING
Los Angeles
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WITHDRAWN
Orange
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ACTIVE_NOT_RECRUITING
Upland
Connecticut
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WITHDRAWN
New Haven
Delaware
Research Site
WITHDRAWN
Newark
Florida
Research Site
WITHDRAWN
Hallandale
Research Site
ACTIVE_NOT_RECRUITING
Plantation
Research Site
WITHDRAWN
Sun City Center
Georgia
Research Site
ACTIVE_NOT_RECRUITING
Atlanta
Kentucky
Research Site
ACTIVE_NOT_RECRUITING
Louisville
Missouri
Research Site
WITHDRAWN
St Louis
North Carolina
Research Site
ACTIVE_NOT_RECRUITING
Winston-salem
New Jersey
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WITHDRAWN
Newark
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ACTIVE_NOT_RECRUITING
Summit
New Mexico
Research Site
WITHDRAWN
Las Cruces
Nevada
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WITHDRAWN
Las Vegas
New York
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WITHDRAWN
Great Neck
Research Site
ACTIVE_NOT_RECRUITING
Manhasset
Research Site
WITHDRAWN
New York
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ACTIVE_NOT_RECRUITING
New York
Ohio
Research Site
ACTIVE_NOT_RECRUITING
Middleburg Heights
Pennsylvania
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WITHDRAWN
Danville
Texas
Research Site
WITHDRAWN
Allen
Research Site
ACTIVE_NOT_RECRUITING
Colleyville
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ACTIVE_NOT_RECRUITING
Edinburg
Research Site
ACTIVE_NOT_RECRUITING
El Paso
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ACTIVE_NOT_RECRUITING
Houston
Other Locations
Argentina
Research Site
ACTIVE_NOT_RECRUITING
Caba
Research Site
ACTIVE_NOT_RECRUITING
Ciudad De Buenos Aires
Research Site
WITHDRAWN
Córdoba
Research Site
ACTIVE_NOT_RECRUITING
La Plata
Research Site
ACTIVE_NOT_RECRUITING
Rosario
Research Site
ACTIVE_NOT_RECRUITING
San Juan
Research Site
WITHDRAWN
San Miguel De Tucumán
Belgium
Research Site
ACTIVE_NOT_RECRUITING
Brussels
Research Site
ACTIVE_NOT_RECRUITING
Leuven
Research Site
ACTIVE_NOT_RECRUITING
Liège
Brazil
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ACTIVE_NOT_RECRUITING
Belo Horizonte
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ACTIVE_NOT_RECRUITING
Campinas
Research Site
ACTIVE_NOT_RECRUITING
Cuiabá
Research Site
WITHDRAWN
Juiz De Fora
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ACTIVE_NOT_RECRUITING
Maringá
Research Site
ACTIVE_NOT_RECRUITING
Porto Alegre
Research Site
ACTIVE_NOT_RECRUITING
Recife
Research Site
ACTIVE_NOT_RECRUITING
Salvador
Research Site
ACTIVE_NOT_RECRUITING
São José Do Rio Preto
Research Site
ACTIVE_NOT_RECRUITING
São Paulo
Research Site
ACTIVE_NOT_RECRUITING
São Paulo
Research Site
ACTIVE_NOT_RECRUITING
São Paulo
Bulgaria
Research Site
WITHDRAWN
Plovdiv
Research Site
COMPLETED
Plovdiv
Research Site
COMPLETED
Sofia
Research Site
WITHDRAWN
Sofia
Research Site
WITHDRAWN
Sofia
China
Research Site
ACTIVE_NOT_RECRUITING
Beijing
Research Site
ACTIVE_NOT_RECRUITING
Beijing
Research Site
ACTIVE_NOT_RECRUITING
Bengbu
Research Site
ACTIVE_NOT_RECRUITING
Chengdu
Research Site
WITHDRAWN
Guangzhou
Research Site
ACTIVE_NOT_RECRUITING
Guangzhou
Research Site
ACTIVE_NOT_RECRUITING
Haikou
Research Site
ACTIVE_NOT_RECRUITING
Hangzhou
Research Site
ACTIVE_NOT_RECRUITING
Jinan
Research Site
ACTIVE_NOT_RECRUITING
Jining
Research Site
ACTIVE_NOT_RECRUITING
Nanchang
Research Site
ACTIVE_NOT_RECRUITING
Nanjing
Research Site
ACTIVE_NOT_RECRUITING
Nanjing
Research Site
ACTIVE_NOT_RECRUITING
Nanning
Research Site
ACTIVE_NOT_RECRUITING
Shanghai
Research Site
ACTIVE_NOT_RECRUITING
Shanghai
Research Site
WITHDRAWN
Shanghai
Research Site
ACTIVE_NOT_RECRUITING
Shengyang
Research Site
ACTIVE_NOT_RECRUITING
Shenzhen
Research Site
ACTIVE_NOT_RECRUITING
Shijiazhuang
Research Site
ACTIVE_NOT_RECRUITING
Tianjin
Research Site
COMPLETED
Wuhan
Research Site
COMPLETED
Wuxi
Research Site
ACTIVE_NOT_RECRUITING
Xi'an
Research Site
ACTIVE_NOT_RECRUITING
Zhengzhou
Colombia
Research Site
ACTIVE_NOT_RECRUITING
Barranquilla
Research Site
WITHDRAWN
Cali
Research Site
ACTIVE_NOT_RECRUITING
Medellín
Research Site
ACTIVE_NOT_RECRUITING
Medellín
Research Site
WITHDRAWN
Medellín
France
Research Site
ACTIVE_NOT_RECRUITING
Aurillac
Research Site
RECRUITING
Bordeaux
Research Site
ACTIVE_NOT_RECRUITING
Marseille
Research Site
ACTIVE_NOT_RECRUITING
Paris
Research Site
ACTIVE_NOT_RECRUITING
Paris
Research Site
ACTIVE_NOT_RECRUITING
Paris
Research Site
ACTIVE_NOT_RECRUITING
Strasbourg
Research Site
ACTIVE_NOT_RECRUITING
Toulouse
Germany
Research Site
TERMINATED
Cologne
Research Site
ACTIVE_NOT_RECRUITING
Dresden
Research Site
WITHDRAWN
Essen
Research Site
WITHDRAWN
Göttingen
Research Site
TERMINATED
Hanover
Research Site
ACTIVE_NOT_RECRUITING
Heidelberg
Research Site
ACTIVE_NOT_RECRUITING
Kirchheim
Research Site
ACTIVE_NOT_RECRUITING
Mainz Am Rhein
Research Site
WITHDRAWN
Stuttgart
Hungary
Research Site
WITHDRAWN
Budapest
Research Site
ACTIVE_NOT_RECRUITING
Budapest
Research Site
ACTIVE_NOT_RECRUITING
Budapest
Research Site
COMPLETED
Debrecen
Research Site
WITHDRAWN
Pécs
India
Research Site
ACTIVE_NOT_RECRUITING
Ahmedabad
Research Site
TERMINATED
Ahmedabad
Research Site
ACTIVE_NOT_RECRUITING
Dehradun
Research Site
WITHDRAWN
Delhi
Research Site
ACTIVE_NOT_RECRUITING
Delhi
Research Site
WITHDRAWN
Delhi
Research Site
WITHDRAWN
Gurugram
Research Site
ACTIVE_NOT_RECRUITING
Hyderabad
Research Site
ACTIVE_NOT_RECRUITING
Kolkata
Research Site
TERMINATED
Nadiād
Research Site
WITHDRAWN
New Delhi
Research Site
WITHDRAWN
New Delhi
Research Site
WITHDRAWN
New Delhi
Research Site
TERMINATED
Pune
Research Site
ACTIVE_NOT_RECRUITING
Secunderabad
Research Site
TERMINATED
Vijayawada
Research Site
TERMINATED
Visakapatnam
Italy
Research Site
COMPLETED
Ancona
Research Site
RECRUITING
Bologna
Research Site
WITHDRAWN
Brescia
Research Site
TERMINATED
Cona
Research Site
RECRUITING
Eboli
Research Site
WITHDRAWN
Monza
Research Site
ACTIVE_NOT_RECRUITING
Padua
Research Site
RECRUITING
Roma
Research Site
WITHDRAWN
Roma
Japan
Research Site
ACTIVE_NOT_RECRUITING
Bunkyō City
Research Site
ACTIVE_NOT_RECRUITING
Chiba
Research Site
WITHDRAWN
Chūōku
Research Site
WITHDRAWN
Fukuoka
Research Site
WITHDRAWN
Gifu
Research Site
ACTIVE_NOT_RECRUITING
Hiroshima
Research Site
WITHDRAWN
Izumo-shi
Research Site
ACTIVE_NOT_RECRUITING
Kita-gun
Research Site
ACTIVE_NOT_RECRUITING
Kitakyushu-shi
Research Site
ACTIVE_NOT_RECRUITING
Matsumoto-shi
Research Site
ACTIVE_NOT_RECRUITING
Nagasaki
Research Site
ACTIVE_NOT_RECRUITING
Okayama
Research Site
ACTIVE_NOT_RECRUITING
Ono
Research Site
WITHDRAWN
Osaka
Research Site
ACTIVE_NOT_RECRUITING
Sagamihara-shi
Research Site
WITHDRAWN
Sapporo
Research Site
ACTIVE_NOT_RECRUITING
Sendai
Research Site
ACTIVE_NOT_RECRUITING
Shinagawa-ku
Research Site
ACTIVE_NOT_RECRUITING
Shinjuku-ku
Research Site
ACTIVE_NOT_RECRUITING
Shinjuku-ku
Research Site
ACTIVE_NOT_RECRUITING
Shinjuku-ku
Research Site
ACTIVE_NOT_RECRUITING
Toyoake-shi
Malaysia
Research Site
ACTIVE_NOT_RECRUITING
Batu Caves
Research Site
ACTIVE_NOT_RECRUITING
Ipoh
Research Site
ACTIVE_NOT_RECRUITING
Kajang
Research Site
ACTIVE_NOT_RECRUITING
Kuala Lumpur
Research Site
ACTIVE_NOT_RECRUITING
Kuantan
Research Site
ACTIVE_NOT_RECRUITING
Taiping
Mexico
Research Site
ACTIVE_NOT_RECRUITING
Chihuahua City
Research Site
ACTIVE_NOT_RECRUITING
Guadalajara
Research Site
ACTIVE_NOT_RECRUITING
Guadalajara
Research Site
ACTIVE_NOT_RECRUITING
México
Research Site
ACTIVE_NOT_RECRUITING
México
Research Site
COMPLETED
San Luis Potosí City
Netherlands
Research Site
ACTIVE_NOT_RECRUITING
Amsterdam
Peru
Research Site
WITHDRAWN
Bellavista
Research Site
ACTIVE_NOT_RECRUITING
Lima
Research Site
ACTIVE_NOT_RECRUITING
Lima
Research Site
ACTIVE_NOT_RECRUITING
Lima
Research Site
WITHDRAWN
Lima
Research Site
ACTIVE_NOT_RECRUITING
Lima
Research Site
ACTIVE_NOT_RECRUITING
Lima
Research Site
ACTIVE_NOT_RECRUITING
Lima
Research Site
WITHDRAWN
Lima
Research Site
WITHDRAWN
Lima
Research Site
WITHDRAWN
Piura
Poland
Research Site
WITHDRAWN
Bydgoszcz
Research Site
ACTIVE_NOT_RECRUITING
Lodz
Research Site
WITHDRAWN
Nadarzyn
Research Site
ACTIVE_NOT_RECRUITING
Olsztyn
Research Site
ACTIVE_NOT_RECRUITING
Opole
Research Site
ACTIVE_NOT_RECRUITING
Poznan
Research Site
ACTIVE_NOT_RECRUITING
Poznan
Research Site
ACTIVE_NOT_RECRUITING
Rzeszów
Research Site
WITHDRAWN
Szczecin
Research Site
RECRUITING
Warsaw
Research Site
WITHDRAWN
Wroclaw
Research Site
WITHDRAWN
Wroclaw
Puerto Rico
Research Site
ACTIVE_NOT_RECRUITING
Caguas
Research Site
WITHDRAWN
San Juan
Russian Federation
Research Site
WITHDRAWN
Chelyabinsk
Research Site
WITHDRAWN
Krasnoyarsk
Research Site
TERMINATED
Moscow
Research Site
WITHDRAWN
Moscow
Research Site
WITHDRAWN
Novosibirsk
Research Site
WITHDRAWN
Orenburg
Research Site
WITHDRAWN
Saint Petersburg
Taiwan
Research Site
RECRUITING
Kaohsiung City
Research Site
RECRUITING
New Taipei City
Research Site
COMPLETED
Taichung
Research Site
RECRUITING
Taichung
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Research Site
WITHDRAWN
Taoyuan District
Thailand
Research Site
ACTIVE_NOT_RECRUITING
Bangkok
Research Site
ACTIVE_NOT_RECRUITING
Bangkok
Research Site
ACTIVE_NOT_RECRUITING
Hat Yai
Research Site
ACTIVE_NOT_RECRUITING
Muang
Research Site
ACTIVE_NOT_RECRUITING
Ratchathewi
Turkey
Research Site
ACTIVE_NOT_RECRUITING
Adapazarı
Research Site
ACTIVE_NOT_RECRUITING
Ankara
Research Site
ACTIVE_NOT_RECRUITING
Ankara
Research Site
WITHDRAWN
Ankara
Research Site
ACTIVE_NOT_RECRUITING
Istanbul
Research Site
ACTIVE_NOT_RECRUITING
Istanbul
Research Site
ACTIVE_NOT_RECRUITING
Izmir
Research Site
ACTIVE_NOT_RECRUITING
Kahramanmaraş
Research Site
ACTIVE_NOT_RECRUITING
Kayseri
Research Site
ACTIVE_NOT_RECRUITING
Kocaeli
Viet Nam
Research Site
ACTIVE_NOT_RECRUITING
Hà Nội
Research Site
COMPLETED
Hà Nội
Research Site
TERMINATED
Hanoi
Research Site
ACTIVE_NOT_RECRUITING
Hanoi
Research Site
ACTIVE_NOT_RECRUITING
Ho Chi Minh City
Research Site
RECRUITING
Ho Chi Minh City
Research Site
ACTIVE_NOT_RECRUITING
Hochiminh
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2022-02-15
Estimated Completion Date: 2028-12-05
Participants
Target number of participants: 360
Treatments
Experimental: Anifrolumab
Solution for intravenous infusion
Placebo_comparator: Placebo
Solution for intravenous infusion
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov