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: Active_not_recruiting
Location: See all (167) 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
Arizona
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Glendale
California
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La Palma
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Los Angeles
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Upland
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Plantation
Georgia
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Atlanta
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Louisville
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Winston-salem
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Summit
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Manhasset
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New York
Ohio
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Middleburg Heights
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Colleyville
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Edinburg
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El Paso
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Houston
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Argentina
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Caba
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Ciudad De Buenos Aires
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Liège
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Belo Horizonte
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Recife
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Nagasaki
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Okayama
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Ono
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Toyoake-shi
Malaysia
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Ipoh
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Kuantan
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Taiping
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Guadalajara
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San Luis Potosí City
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Amsterdam
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Lima
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Caguas
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Moscow
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Kaohsiung City
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New Taipei City
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Muang
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Ankara
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Istanbul
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Kocaeli
Viet Nam
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Hà Nội
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Hanoi
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Hanoi
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Ho Chi Minh City
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Hochiminh
Time Frame
Start Date: 2022-02-15
Completion Date: 2028-12-05
Participants
Target number of participants: 359
Treatments
Experimental: Anifrolumab
Solution for intravenous infusion
Placebo_comparator: Placebo
Solution for intravenous infusion
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca