Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
NCT ID: NCT05138133
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2022-02-15
2028-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Anifrolumab
Solution for intravenous infusion
Anifrolumab
Anifrolumab intravenous infusion (IV)
Placebo
Solution for intravenous infusion
Placebo
Placebo intravenous infusion (IV)
Interventions
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Anifrolumab
Anifrolumab intravenous infusion (IV)
Placebo
Placebo intravenous infusion (IV)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
3. Urine protein to creatinine ratio \> 1 mg/mg (113.17 mg/mmol)
4. eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
5. Fulfills updated 2019 EULAR/ACR SLE classification criteria.
6. No signs of symptoms of active TB prior to or during screening or no treatment for latent TB
Exclusion Criteria
2. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1).
3. Evidence of hepatitis C or active hepatitis B.
4. Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
5. Receipt of the following for the current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide \> 2 pulses of high-dose (≥ 0.5 g/m2) or \> 4 doses of low dose (500 mg every 2 weeks) or Average MMF \> 2.5 g/day (or \> 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus \> 4 mg/day for more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior the ICF.
6. Previous receipt of \>◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
7. Known intolerance to ≤ 1.0 g/day of MMF.
8. Any history of severe COVID-19 infection.
18 Years
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
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Glendale, Arizona, United States
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La Jolla, California, United States
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La Palma, California, United States
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Loma Linda, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Upland, California, United States
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New Haven, Connecticut, United States
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Newark, Delaware, United States
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Hallandale, Florida, United States
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Plantation, Florida, United States
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Sun City Center, Florida, United States
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Atlanta, Georgia, United States
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Louisville, Kentucky, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Newark, New Jersey, United States
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Summit, New Jersey, United States
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Las Cruces, New Mexico, United States
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Great Neck, New York, United States
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Manhasset, New York, United States
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New York, New York, United States
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New York, New York, United States
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Winston-Salem, North Carolina, United States
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Middleburg Heights, Ohio, United States
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Danville, Pennsylvania, United States
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Allen, Texas, United States
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Colleyville, Texas, United States
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Edinburg, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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CABA, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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La Plata, , Argentina
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Rosario, , Argentina
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San Juan, , Argentina
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San Miguel de Tucumán, , Argentina
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Brussels, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Belo Horizonte, , Brazil
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Campinas, , Brazil
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Cuiabá, , Brazil
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Juiz de Fora, , Brazil
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Maringá, , Brazil
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Porto Alegre, , Brazil
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Recife, , Brazil
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Salvador, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Beijing, , China
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Beijing, , China
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Bengbu, , China
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Chengdu, , China
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Guangzhou, , China
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Guangzhou, , China
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Haikou, , China
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Hangzhou, , China
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Jinan, , China
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Jining, , China
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Nanchang, , China
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Nanjing, , China
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Nanjing, , China
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Nanning, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shengyang, , China
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Shenzhen, , China
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Shijiazhuang, , China
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Tianjin, , China
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Wuhan, , China
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Wuxi, , China
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Xi'an, , China
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Zhengzhou, , China
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Barranquilla, , Colombia
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Cali, , Colombia
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Medellín, , Colombia
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Medellín, , Colombia
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Medellín, , Colombia
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Aurillac, , France
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Bordeaux, , France
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Marseille, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Strasbourg, , France
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Toulouse, , France
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Cologne, , Germany
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Dresden, , Germany
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Essen, , Germany
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Göttingen, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Kirchheim, , Germany
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Mainz Am Rhein, , Germany
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Stuttgart, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Pécs, , Hungary
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Ahmedabad, , India
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Ahmedabad, , India
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Dehradun, , India
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Delhi, , India
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Delhi, , India
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Delhi, , India
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Gurugram, , India
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Hyderabad, , India
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Kolkata, , India
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Nadiād, , India
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New Delhi, , India
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New Delhi, , India
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New Delhi, , India
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Pune, , India
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Secunderabad, , India
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Vijayawada, , India
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Visakapatnam, , India
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Ancona, , Italy
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Bologna, , Italy
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Brescia, , Italy
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Cona, , Italy
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Eboli, , Italy
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Monza, , Italy
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Padua, , Italy
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Roma, , Italy
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Roma, , Italy
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Bunkyō City, , Japan
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Chiba, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Gifu, , Japan
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Hiroshima, , Japan
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Izumo-shi, , Japan
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Kita-gun, , Japan
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Kitakyushu-shi, , Japan
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Matsumoto-shi, , Japan
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Nagasaki, , Japan
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Okayama, , Japan
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Ono, , Japan
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Osaka, , Japan
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Sagamihara-shi, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shinagawa-ku, , Japan
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Shinjuku-ku, , Japan
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Shinjuku-ku, , Japan
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Shinjuku-ku, , Japan
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Toyoake-shi, , Japan
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Batu Caves, , Malaysia
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Ipoh, , Malaysia
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Kajang, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuantan, , Malaysia
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Taiping, , Malaysia
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Chihuahua City, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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México, , Mexico
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México, , Mexico
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San Luis Potosí City, , Mexico
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Amsterdam, , Netherlands
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Bellavista, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Piura, , Peru
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Bydgoszcz, , Poland
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Lodz, , Poland
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Nadarzyn, , Poland
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Olsztyn, , Poland
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Opole, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Rzeszów, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Caguas, , Puerto Rico
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San Juan, , Puerto Rico
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Chelyabinsk, , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Orenburg, , Russia
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Saint Petersburg, , Russia
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Kaohsiung 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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Taipei, , 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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Hat Yai, , Thailand
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Muang, , Thailand
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Ratchathewi, , Thailand
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Adapazarı, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kahramanmaraş, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Hà Nội, , Vietnam
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Hà Nội, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
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Hochiminh, , Vietnam
Countries
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Central Contacts
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References
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Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.
Other Identifiers
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2021-002862-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D3466C00001
Identifier Type: -
Identifier Source: org_study_id
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