Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
Launched by ALEXION PHARMACEUTICALS, INC. · Feb 26, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called ravulizumab to see if it can help adults with a kidney condition known as Immunoglobulin A Nephropathy (IgAN). The main goals are to find out if ravulizumab can reduce the amount of protein in the urine (which is a sign of kidney problems) and slow down the decline in kidney function over time. The trial is currently looking for adult participants aged 65 to 74 who have been diagnosed with IgAN and meet certain health criteria, such as having specific levels of kidney function and protein in their urine.
If you or a loved one is considering participating, you would need to have a confirmed diagnosis of IgAN, and your kidney function must be within a certain range. Participants will receive either the medication or a placebo (a non-active treatment) for the study period, and you will be monitored closely for any changes in kidney health. It's important to know that there are specific health conditions that would exclude someone from participating, such as recent significant kidney disease or certain infections. This trial offers an opportunity to contribute to research that could lead to new treatments for IgAN.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period for participants with eGFR ≥ 30 mL/min/1.73 m\^2.
- • 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:
- • Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to Screening.
- • 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.
About Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc. is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for patients with rare and complex diseases. With a strong focus on addressing unmet medical needs, Alexion leverages advanced science and technology to create transformative treatments that improve the quality of life for patients suffering from conditions such as complement-mediated disorders, neurology, hematology, and metabolic diseases. Committed to patient-centric approaches, Alexion collaborates with healthcare professionals, patients, and advocacy groups to drive clinical research and foster advancements in rare disease treatment.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Orlando, Florida, United States
Brussels, , Belgium
Edegem, , Belgium
Liège, , Belgium
Malaga, , Spain
Oviedo, , Spain
Sevilla, , Spain
Aurora, Colorado, United States
Houston, Texas, United States
San Diego, California, United States
San Antonio, Texas, United States
Bay Pines, Florida, United States
New York, New York, United States
Columbus, Ohio, United States
Berlin, , Germany
Zaragoza, , Spain
San Francisco, California, United States
Leuven, , Belgium
Roeselare, , Belgium
Paris, , France
Jerusalem, , Israel
Padova, , Italy
New Orleans, Louisiana, United States
Miskolc, , Hungary
Praha 4, , Czechia
Lérida, , Spain
Dundee, , United Kingdom
Miami, Florida, United States
Iowa City, Iowa, United States
Paris, , France
Erlangen, , Germany
London, , United Kingdom
Graz, , Austria
Innsbruck, , Austria
Camperdown, , Australia
Parkville, , Australia
Marseille, , France
Strasbourg, , France
Toulouse, , France
Essen, , Germany
Hannover, , Germany
München, , Germany
Athens, , Greece
Bari, , Italy
Lublin, , Poland
Málaga, , Spain
Albany, New York, United States
Charlottesville, Virginia, United States
Orange, California, United States
Loma Linda, California, United States
Kansas City, Missouri, United States
Toronto, Ontario, Canada
Santiago, , Chile
Mainz, , Germany
Rotterdam, , Netherlands
Boston, Massachusetts, United States
Milwaukee, Wisconsin, United States
Herston, , Australia
Chihuahua, , Mexico
Stanford, California, United States
Boston, Massachusetts, United States
Charleston, South Carolina, United States
Botucatu, , Brazil
Patras, , Greece
Thessaloniki, , Greece
Firenze, , Italy
Milano, , Italy
Köln, , Germany
Cambridge, , United Kingdom
Linz, , Austria
Brescia, , Italy
Shreveport, Louisiana, United States
Tel Aviv, , Israel
Szczecin, , Poland
Konstanz, , Germany
Taichung City, , Taiwan
Concord, , Australia
Taichung, , Taiwan
Perth, , Australia
East Setauket, New York, United States
Amiens, , France
Nice, , France
Olsztyn, , Poland
Warszawa, , Poland
Martin, , Slovakia
North Las Vegas, Nevada, United States
Knoxville, Tennessee, United States
Beijing, , China
Shanghai, , China
Clermont Ferrand, , France
Mexico, , Mexico
Bologna, , Italy
Salford, , United Kingdom
Aachen, , Germany
Verona, , Italy
Torino, , Italy
Stevenage, , United Kingdom
Zhengzhou, , China
Ottawa, Ontario, Canada
Bratislava, , Slovakia
London, Ontario, Canada
Suwon Si, , Korea, Republic Of
Taipei, , Taiwan
Bangkok, , Thailand
Torrance, California, United States
Porto, , Portugal
Amsterdam, , Netherlands
Buenos Aires, , Argentina
Clayton, , Australia
Chongqing, , China
Guangzhou, , China
Xian, , China
Yinchuan, , China
Manizales, , Colombia
Budapest, , Hungary
Nazareth, , Israel
Busan, , Korea, Republic Of
Kuala Lumpur, , Malaysia
Taiping, , Malaysia
Lublin, , Poland
Cluj Napoca, , Romania
Alcalá De Henares, , Spain
Kaohsiung, , Taiwan
Bayonne, , France
Greifswald, , Germany
Amiens Cedex 1, , France
Istanbul, , Turkey
Lawrenceville, Georgia, United States
Nantes, , France
La Plata, , Argentina
Ipoh, , Malaysia
Hangzhou, , China
Shenyang, , China
Parma, , Italy
Valencia, , Spain
Seoul, , Korea, Republic Of
Los Angeles, California, United States
Northridge, California, United States
Pontiac, Michigan, United States
Saint Peters, Missouri, United States
Gwangju, , Korea, Republic Of
Phoenix, Arizona, United States
Nanchang, , China
Kaohsiung City, , Taiwan
Rosario, , Argentina
Changsha, , China
Wuxi, , China
Matsuyama Shi, , Japan
Bursa, , Turkey
Kocaeli, , Turkey
Konya, , Turkey
Villingen Schwenningen, , Germany
Warszawa, , Poland
Kobe Shi, , Japan
Poznań, , Poland
Jinan, , China
Nanjing, , China
Shenzhen, , China
Ankara, , Turkey
Białystok, , Poland
Toyota Shi, , Japan
Culiacan, , Mexico
Dammam, , Saudi Arabia
Jeddah, , Saudi Arabia
Madrid, , Spain
New Taipei City, , Taiwan
Kayseri, , Turkey
Augusta, Maine, United States
Tainan City, , Taiwan
Istanbul, , Turkey
Osaka Shi, , Japan
Shatin, , Hong Kong
Zhanjiang, , China
Bunkyo Ku, , Japan
Taipei, , Taiwan
Kasugai Shi, , Japan
Florencio Varela, , Argentina
Khon Kaen, , Thailand
Curitiba, , Brazil
Winnipeg, Manitoba, Canada
Cali, , Colombia
łódź, , Poland
Haifa, , Israel
Barranquilla, , Colombia
Anyang Si, , Korea, Republic Of
Taoyuan City, , Taiwan
Liverpool, , Australia
Matsumoto Shi, , Japan
Cagliari, , Italy
Doncaster, , United Kingdom
Minneapolis, Minnesota, United States
Bronx, New York, United States
Baotou, , China
Lanzhou, , China
Urumqi, , China
Yantai, , China
Guadalajara, , Mexico
Ningbo, , China
La Coruña, , Spain
Jinhua, , China
Piacenza, , Italy
Gyeonggi Do, , Korea, Republic Of
Belo Horizonte, , Brazil
Pamukkale, , Turkey
Wuhan, , China
Fukuoka Shi, , Japan
Córdoba, , Argentina
Deagu, , Korea, Republic Of
Qingdao, , China
Zhengzhou, , China
Le Kremlin Bicêtre, , France
Nice Cedex 1, , France
Fortaleza, , Brazil
Johor Bahru, , Malaysia
Seremban, , Malaysia
Chengdu, , China
St Albans, , Australia
Khlong Luang, , Thailand
Belo Horizonte, , Brazil
Kraków, , Poland
Groningen, , Netherlands
Hong Kong, , Hong Kong
Canberra, , Australia
Bucuresti, , Romania
Changzhou, , China
Chiba Shi, , Japan
Bogota, , Colombia
Ribeirão Preto, , Brazil
Cordoba, , Argentina
Lai Chi Kok, , Hong Kong
Braga, , Portugal
Chaingmai, , Thailand
Acworth, Georgia, United States
Kitakyushu Shi, , Japan
Urayasu Shi, , Japan
Shenandoah, Texas, United States
Banská Bystrica, , Slovakia
Arlington, Texas, United States
Riyadh, , Saudi Arabia
Zapopan, , Mexico
Kahramanmaras, , Turkey
Murcia, , Spain
Salvador, , Brazil
S.J. Do Rio Preto, , Brazil
Providencia, , Chile
Petah Tikva, , Israel
Timisoara, , Romania
Southport, , Australia
Sr Priest En Jarez, , France
Leicester, , United Kingdom
Medellín, , Colombia
Yibin, , China
Reading, , United Kingdom
Rionegro, , Colombia
Heraclion, , Greece
Sapporo Shi, , Japan
Ciudad Autonoma Bs As, , Argentina
Saint Priest En Jarez, , France
San Luis, , Argentina
Recife, , Brazil
São Paulo, , Brazil
Araucania, , Chile
Valdivia, , Chile
Brest Cedex, , France
Chambéry Cedex, , France
Agrigento, , Italy
Ashikaga, , Japan
Kamakura, , Japan
Nagoya, , Japan
Nijmegen, , Netherlands
Sant Joan Despí, , Spain
Tarragona, , Spain
Juriquilla, , Mexico
Luoyang, , China
Alabaster, Alabama, United States
Nový Jičín, , Czechia
Praha 2, , Czechia
Torrette, , Italy
Košice, , Slovakia
Zhongshan, , China
Valdivia, , Chile
Chambéry, , France
Funchal, , Portugal
Lisbon, , Portugal
Torres Novas, , Portugal
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported