Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
NCT ID: NCT06291376
Last Updated: 2026-01-21
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
510 participants
INTERVENTIONAL
2024-03-29
2030-07-19
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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Ravulizumab IV q8w
Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered every 8 weeks (q8w).
Ravulizumab
Participants will receive ravulizumab via weight-based intravenous (IV) infusion.
Placebo IV q8w
Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered q8w.
Placebo
Participants will receive placebo via weight-based IV infusion.
Interventions
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Ravulizumab
Participants will receive ravulizumab via weight-based intravenous (IV) infusion.
Placebo
Participants will receive placebo via weight-based IV infusion.
Eligibility Criteria
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Inclusion Criteria
* For participants in the AdKD cohorts, eGFR 20 to 29 mL/min/1.73 m2 a kidney biopsy is required within 6 months prior to Screening or during the Screening Period.
* UPCR ≥ 0.75 g/g or UP ≥1 g/day calculated from the mean of two 24-hour urine during the Screening Period.
* Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening.
* Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106.
* Participants who are receiving SGLT2I, DEARA, MRA or ERA must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to Screening with no planned change in dose through Week 106.
Exclusion Criteria
* Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease; IgAV-N may be eligible).
* Concomitant clinically significant renal disease other than IgAN.
* Prior use of immunosuppressive treatment within 3 months of screening.
* Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 8.5%.
* Henoch-Schonlein purpura (IgAV) requiring systemic immunosuppressive therapy within 12 months of Screening.
* History of kidney transplant or planned kidney transplant during the Treatment Period.
* Splenectomy or functional asplenia.
* History of Neisseria meningitidis infection.
* Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Alabaster, Alabama, United States
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Phoenix, Arizona, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Stanford, California, United States
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Torrance, California, United States
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Valencia, California, United States
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Aurora, Colorado, United States
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Bay Pines, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Acworth, Georgia, United States
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Atlanta, Georgia, United States
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Lawrenceville, Georgia, United States
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Meridian, Idaho, United States
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Iowa City, Iowa, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Augusta, Maine, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Pontiac, Michigan, United States
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Minneapolis, Minnesota, United States
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Minneapolis, Minnesota, United States
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City of Saint Peters, Missouri, United States
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Kansas City, Missouri, United States
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North Las Vegas, Nevada, United States
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Albany, New York, United States
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East Setauket, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Columbus, Ohio, United States
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Charleston, South Carolina, United States
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Knoxville, Tennessee, United States
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Arlington, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Shenandoah, Texas, United States
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Temple, Texas, United States
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Charlottesville, Virginia, United States
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Milwaukee, Wisconsin, United States
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Ciudad de Buenos Aires, , 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 Bautista, , Argentina
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San Luis, , Argentina
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Camperdown, , Australia
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Canberra, , Australia
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Clayton, , Australia
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Concord, , Australia
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Herston, , Australia
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Liverpool, , Australia
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Parkville, , Australia
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Perth, , Australia
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Southport, , Australia
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St Albans, , Australia
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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Brussels, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Roeselare, , Belgium
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Belo Horizonte, , Brazil
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Belo Horizonte, , Brazil
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Belo Horizonte, , Brazil
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Botucatu, , Brazil
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Curitiba, , Brazil
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Fortaleza, , Brazil
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Recife, , Brazil
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Ribeirão Preto, , 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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Winnipeg, Manitoba, Canada
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Brampton, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Araucania, , Chile
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Providencia, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Valdivia, , Chile
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Baotou, , China
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Beijing, , China
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Beijing, , China
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Changsha, , China
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Changzhou, , China
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Chengdu, , China
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Chongqing, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Jinan, , China
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Jinan, , China
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Jinhua, , China
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Lanzhou, , China
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Luoyang, , China
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Nanchang, , China
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Nanchang, , China
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Nanjing, , China
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Nanjing, , China
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Nanjing, , China
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Ningbo, , China
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Qingdao, , China
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Shanghai, , China
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Shenyang, , China
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Shenzhen, , China
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Shenzhen, , China
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Ürümqi, , China
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Wuhan, , China
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Wuxi, , China
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Xi'an, , China
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Yantai, , China
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Yibin, , China
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Yinchuan, , China
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Zhanjiang, , China
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Zhengzhou, , China
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Zhongshan, , China
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Cali, , Colombia
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Manizales, , Colombia
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Medellín, , Colombia
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Rionegro, , Colombia
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Nový Jičín, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Amiens, , France
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Bayonne, , France
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Brest, , France
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Chambéry, , France
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Clermont-Ferrand, , France
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Le Kremlin-Bicêtre, , France
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Marseille, , France
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Nantes, , France
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Nice, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Saint-Priest-en-Jarez, , France
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Strasbourg, , France
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Toulouse, , France
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Aachen, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Greifswald, , Germany
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Hanover, , Germany
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Konstanz, , Germany
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Mainz, , Germany
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München, , Germany
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München, , Germany
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Villingen-Schwenningen, , Germany
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Athens, , Greece
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Athens, , Greece
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Heraklion, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Hong Kong, , Hong Kong
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Hong Kong, , Hong Kong
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Lai Chi Kok, , Hong Kong
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Budapest, , Hungary
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Miskolc, , Hungary
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Haifa, , Israel
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Jerusalem, , Israel
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Nazareth, , Israel
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Petah Tikva, , Israel
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Tel Aviv, , Israel
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Agrigento, , Italy
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Bari, , Italy
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Bologna, , Italy
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Brescia, , Italy
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Cagliari, , Italy
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Florence, , Italy
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Milan, , Italy
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Padua, , Italy
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Parma, , Italy
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Piacenza, , Italy
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Torino, , Italy
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Torrette, , Italy
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Verona, , Italy
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Ashikaga, , Japan
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Bunkyō City, , Japan
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Chiba, , Japan
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Chiba, , Japan
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Fukuoka, , Japan
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Kamakura, , Japan
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Kasugai-shi, , Japan
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Kitakyushu-shi, , Japan
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Kobe, , Japan
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Matsumoto-shi, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Sapporo, , Japan
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Toyota-Shi, , Japan
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Urayasu-shi, , Japan
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Ipoh, , Malaysia
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Johor Bahru, , Malaysia
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Kuala Lumpur, , Malaysia
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Seremban, , Malaysia
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Taiping, , Malaysia
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Chihuahua City, , Mexico
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Culiacán, , Mexico
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Guadalajara, , Mexico
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Juriquilla, , Mexico
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México, , Mexico
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Zapopan, , Mexico
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Amsterdam, , Netherlands
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Groningen, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Bialystok, , Poland
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Bialystok, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Braga, , Portugal
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Funchal, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Torres Novas, , Portugal
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Timișoara, , Romania
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Dammam, , Saudi Arabia
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Jeddah, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Martin, , Slovakia
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Anyang-si, , South Korea
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Busan, , South Korea
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Deagu, , South Korea
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Gwangju, , South Korea
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Gyeonggi-do, , 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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Suwon, , South Korea
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A Coruña, , Spain
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Alcalá de Henares, , Spain
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Lleida, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Murcia, , Spain
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Oviedo, , Spain
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Sant Joan Despí, , Spain
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Seville, , Spain
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Tarragona, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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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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Tainan, , 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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Chaingmai, , Thailand
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Khlong Luang, , Thailand
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Khon Kaen, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , 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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Konya, , Turkey (Türkiye)
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Pamukkale, , Turkey (Türkiye)
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Cambridge, , United Kingdom
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Doncaster, , United Kingdom
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Dundee, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Reading, , United Kingdom
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Salford, , United Kingdom
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Stevenage, , United Kingdom
Countries
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Central Contacts
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References
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Lafayette R, Tumlin J, Fenoglio R, Kaufeld J, Perez Valdivia MA, Wu MS, Susan Huang SH, Alamartine E, Kim SG, Yee M, Kateifides A, Rice K, Garlo K, Barratt J; SANCTUARY Study Investigators. Efficacy and Safety of Ravulizumab in IgA Nephropathy: A Phase 2 Randomized Double-Blind Placebo-Controlled Trial. J Am Soc Nephrol. 2025 Apr 1;36(4):645-656. doi: 10.1681/ASN.0000000534. Epub 2024 Oct 25.
Other Identifiers
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D928FC00001
Identifier Type: -
Identifier Source: org_study_id
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