Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

RECRUITING

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The primary objective of this study to evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria and slow the rate of eGFR decline in adult participants with IgAN who are at risk of disease progression.

Conditions:

🦠 Immunoglobulin A Nephropathy 🦠 IgAN

🗓️ Study Start (Actual) 29 March 2024

🗓️ Primary Completion (Estimated) 23 February 2026

✅ Study Completion (Estimated) 25 October 2029

👥 Enrollment (Estimated) 470

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE3

Locations:

📍 Alabaster, Alabama, United States

📍 Phoenix, Arizona, United States

📍 Loma Linda, California, United States

📍 Los Angeles, California, United States

📍 Orange, California, United States

📍 San Francisco, California, United States

📍 Stanford, California, United States

📍 Torrance, California, United States

📍 Aurora, Colorado, United States

📍 Bay Pines, Florida, United States

📍 Miami, Florida, United States

📍 Orlando, Florida, United States

📍 Acworth, Georgia, United States

📍 Lawrenceville, Georgia, United States

📍 Iowa City, Iowa, United States

📍 New Orleans, Louisiana, United States

📍 Augusta, Maine, United States

📍 Boston, Massachusetts, United States

📍 Pontiac, Michigan, United States

📍 Minneapolis, Minnesota, United States

📍 Saint Peters, Missouri, United States

📍 North Las Vegas, Nevada, United States

📍 Albany, New York, United States

📍 Bronx, New York, United States

📍 East Setauket, New York, United States

📍 New York, New York, United States

📍 Columbus, Ohio, United States

📍 Charleston, South Carolina, United States

📍 Knoxville, Tennessee, United States

📍 Arlington, Texas, United States

📍 Houston, Texas, United States

📍 Shenandoah, Texas, United States

📍 Charlottesville, Virginia, United States

📍 Milwaukee, Wisconsin, United States

📍 Ciudad Autonoma Bs As, Argentina

📍 Córdoba, Argentina

📍 La Plata, Argentina

📍 Rosario, Argentina

📍 San Luis, Argentina

📍 Canberra, Australia

📍 Clayton, Australia

📍 Concord, Australia

📍 Herston, Australia

📍 Liverpool, Australia

📍 Perth, Australia

📍 Southport, Australia

📍 St Albans, Australia

📍 Graz, Austria

📍 Innsbruck, Austria

📍 Linz, Austria

📍 Brussels, Belgium

📍 Edegem, Belgium

📍 Leuven, Belgium

📍 Liège, Belgium

📍 Roeselare, Belgium

📍 Belo Horizonte, Brazil

📍 Botucatu, Brazil

📍 Curitiba, Brazil

📍 Fortaleza, Brazil

📍 Recife, Brazil

📍 Ribeirão Preto, Brazil

📍 S.J. Do Rio Preto, Brazil

📍 Salvador, Brazil

📍 São Paulo, Brazil

📍 Winnipeg, Manitoba, Canada

📍 London, Ontario, Canada

📍 Toronto, Ontario, Canada

📍 Araucania, Chile

📍 Providencia, Chile

📍 Santiago, Chile

📍 Valdivia, Chile

📍 Baotou, China

📍 Beijing, China

📍 Changsha, China

📍 Changzhou, China

📍 Chengdu, China

📍 Chongqing, China

📍 Guangzhou, China

📍 Hangzhou, China

📍 Jinan, China

📍 Jinhua, China

📍 Lanzhou, China

📍 Luoyang, China

📍 Nanchang, China

📍 Nanjing, China

📍 Ningbo, China

📍 Qingdao, China

📍 Shanghai, China

📍 Shenyang, China

📍 Shenzhen, China

📍 Urumqi, China

📍 Wuhan, China

📍 Wuxi, China

📍 Xian, China

📍 Yantai, China

📍 Yibin, China

📍 Yinchuan, China

📍 Zhanjiang, China

📍 Zhengzhou, China

📍 Barranquilla, Colombia

📍 Bogota, Colombia

📍 Cali, Colombia

📍 Rionegro, Colombia

📍 Nový Jičín, Czechia

📍 Praha 2, Czechia

📍 Praha 4, Czechia

📍 Amiens Cedex 1, France

📍 Bayonne, France

📍 Brest Cedex, France

📍 Chambéry Cedex, France

📍 Clermont Ferrand, France

📍 Le Kremlin-Bicêtre, France

📍 Marseille, France

📍 Nantes, France

📍 Nice cedex 1, France

📍 Paris, France

📍 Sr Priest En Jarez, France

📍 Strasbourg, France

📍 Toulouse, France

📍 Aachen, Germany

📍 Berlin, Germany

📍 Erlangen, Germany

📍 Essen, Germany

📍 Greifswald, Germany

📍 Hannover, Germany

📍 Köln, Germany

📍 Mainz, Germany

📍 München, Germany

📍 Villingen-Schwenningen, Germany

📍 Athens, Greece

📍 Heraclion, Greece

📍 Patras, Greece

📍 Thessaloniki, Greece

📍 Hong Kong, Hong Kong

📍 Lai Chi Kok, Hong Kong

📍 Shatin, Hong Kong

📍 Budapest, Hungary

📍 Miskolc, Hungary

📍 Haifa, Israel

📍 Jerusalem, Israel

📍 Nazareth, Israel

📍 Petah Tikva, Israel

📍 Tel Aviv, Israel

📍 Agrigento, Italy

📍 Bari, Italy

📍 Bologna, Italy

📍 Brescia, Italy

📍 Cagliari, Italy

📍 Firenze, Italy

📍 Milano, Italy

📍 Padova, Italy

📍 Parma, Italy

📍 Piacenza, Italy

📍 Torino, Italy

📍 Torrette, Italy

📍 Verona, Italy

📍 Ashikaga, Japan

📍 Bunkyo-ku, Japan

📍 Chiba-Shi, Japan

📍 Chiba-shi, Japan

📍 Fukuoka-shi, Japan

📍 Kamakura, Japan

📍 Kasugai-shi, Japan

📍 Kitakyushu-shi, Japan

📍 Kobe-shi, Japan

📍 Matsumoto-shi, Japan

📍 Matsuyama-shi, Japan

📍 Nagoya, Japan

📍 Osaka-shi, Japan

📍 Sapporo-shi, Japan

📍 Toyota-Shi, Japan

📍 Urayasu-shi, Japan

📍 Anyang-si, Korea, Republic of

📍 Busan, Korea, Republic of

📍 Deagu, Korea, Republic of

📍 Gwangju, Korea, Republic of

📍 Gyeonggi-do, Korea, Republic of

📍 Seoul, Korea, Republic of

📍 Suwon-si, Korea, Republic of

📍 Ipoh, Malaysia

📍 Johor Bahru, Malaysia

📍 Kuala Lumpur, Malaysia

📍 Seremban, Malaysia

📍 Taiping, Malaysia

📍 Chihuahua, Mexico

📍 Culiacan, Mexico

📍 Guadalajara, Mexico

📍 Juriquilla, Mexico

📍 Mexico, Mexico

📍 Zapopan, Mexico

📍 Amsterdam, Netherlands

📍 Groningen, Netherlands

📍 Nijmegen, Netherlands

📍 Białystok, Poland

📍 Kraków, Poland

📍 Lublin, Poland

📍 Olsztyn, Poland

📍 Poznań, Poland

📍 Szczecin, Poland

📍 Warszawa, Poland

📍 Łódź, Poland

📍 Dammam, Saudi Arabia

📍 Jeddah, Saudi Arabia

📍 Riyadh, Saudi Arabia

📍 Banská Bystrica, Slovakia

📍 Bratislava, Slovakia

📍 Martin, Slovakia

📍 Alcalá de Henares, Spain

📍 La Coruña, Spain

📍 Lérida, Spain

📍 Madrid, Spain

📍 Málaga, Spain

📍 Oviedo, Spain

📍 Sant Joan Despí, Spain

📍 Sevilla, Spain

📍 Tarragona, Spain

📍 Valencia, Spain

📍 Zaragoza, Spain

📍 Kaohsiung City, Taiwan

📍 Kaohsiung, Taiwan

📍 New Taipei City, Taiwan

📍 Taichung City, Taiwan

📍 Taichung, Taiwan

📍 Tainan City, Taiwan

📍 Taipei, Taiwan

📍 Taoyuan City, Taiwan

📍 Bangkok, Thailand

📍 Chaingmai, Thailand

📍 Khlong Luang, Thailand

📍 Khon Kaen, Thailand

📍 Ankara, Turkey

📍 Bursa, Turkey

📍 Istanbul, Turkey

📍 Kayseri, Turkey

📍 Kocaeli, Turkey

📍 Konya, Turkey

📍 Cambridge, United Kingdom

📍 Doncaster, United Kingdom

📍 Leicester, United Kingdom

📍 London, United Kingdom

📍 Salford, United Kingdom

📍 Stevenage, United Kingdom

More locations available...

📋 Eligibility Criteria

Description

Inclusion Criteria:

* Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period.
* UPCR ≥ 0.75 g/g or UP ≥1 g/day from the mean of two 24-hour urine collections during Screening.
* Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening.
* Exploratory Cohort: eGFR 20-29 mL/min/1.73 m2 at Screening. A kidney biopsy is required within 6 months prior to Screening or during the Screening Period.
* Presence of hematuria as defined by a positive result on urine dipstick for blood or ≥ 5 red blood cells (RBCs)/high power field microscopy on urine sediment during or within 3 months of 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 on an SGLT2I, ERA, or MRA must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to Screening with no planned change 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).
* Concomitant clinically significant renal disease other than IgAN.
* Prior use of immunosuppressive treatment for IgAN within 6 months of screening.
* Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 8.5%.
* Clinically active Henoch-Schonlein purpura (IgA vasculitis) requiring ongoing systemic immunosuppressive therapy at 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.

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 26 February 2024
First Submitted that Met QC Criteria 26 February 2024
First Posted 4 March 2024

Study Record Updates

Last Update Submitted that Met QC Criteria 25 July 2024
Last Update Posted 26 July 2024
Last Verified July 2024