RecruitingPhase 3NCT06291376

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Immunoglobulin A Nephropathy (IgAN)

Sponsor

Alexion Pharmaceuticals, Inc.

Enrollment

510 participants

Start Date

Mar 29, 2024

Study Type

INTERVENTIONAL

Conditions

Immunoglobulin A Nephropathy IgAN

Summary

The primary objective of this study to evaluate efficacy of ravulizumab compared with placebo on proteinuria reduction and change in eGFR in adult participants with IgAN who are at risk of disease progression.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing ravulizumab — an antibody that blocks a part of the immune system called complement — in people with a kidney disease called IgA nephropathy (IgAN). In IgAN, abnormal antibodies build up in the kidneys and cause inflammation and progressive damage. **You may be eligible if...** - You have a confirmed IgAN diagnosis from a kidney biopsy - Your kidney function is reduced but not severely (eGFR of 20 or higher) - Your urine protein levels remain high despite current treatment - You have been on maximum tolerated doses of blood pressure/kidney-protecting medications for at least 3 months **You may NOT be eligible if...** - You have not had a kidney biopsy confirming IgAN - Your kidney function has deteriorated too rapidly or severely - You have an active serious infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRavulizumab

Participants will receive ravulizumab via weight-based intravenous (IV) infusion.

DRUGPlacebo

Participants will receive placebo via weight-based IV infusion.

Locations(267)

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Alabaster, Alabama, United States

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Phoenix, Arizona, United States

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Loma Linda, 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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Los Angeles, California, United States

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Orange, 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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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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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, 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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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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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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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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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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Beijing, China

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Changsha, China

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Changzhou, China

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Chengdu, 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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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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Shanghai, China

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Shanghai, 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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Zhengzhou, China

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Zhongshan, China

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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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Le Kremlin-Bicêtre, France

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Marseille, France

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Nantes, 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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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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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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Milan, Italy

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Padova, Italy

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Parma, Italy

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Torino, Italy

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Torrette, Italy

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Verona, Italy

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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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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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Amsterdam, 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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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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Banská Bystrica, 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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Seville, Spain

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Tarragona, 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, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Chiang Mai, Thailand

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Khon Kaen, Thailand

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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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Manchester, United Kingdom

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Reading, United Kingdom

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Salford, United Kingdom

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Stevenage, United Kingdom

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NCT06291376

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Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(267)

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