A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Immunoglobulin A Nephropathy (IgAN)
In brief
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies. This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys. The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is: • How much does the amount of protein in the urine change from the start of the study to Week 36? Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body. The study will be done as follows: * Participants will be screened to check if they can join the study. * Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine. * Neither the researchers nor the participants will know what the participants will receive. * Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks. * Afterwards, participants will enter a follow-up period which will last 80 weeks. * In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.
Key facts
- Study ID
- NCT06935357
- Run by
- Biogen
- People needed
- 454
- Starts
- 2025-05-08
- Expected to finish
- 2029-06-05
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- INECO Neurociencias Oroño — Rosario, Santa Fe Province, Argentina (enrolling)
- CIMER-Centro Integral de Medicina Respiratoria — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)
- Texas Kidney Institute - Dallas — Dallas, Texas, United States (enrolling)
- Hospital Italiano de Buenos Aires — Almagro, Ciudad Autónoma de BuenosAires, Argentina (enrolling)
- Scripps Green Hospital — Carlsbad, California, United States (enrolling)
- North America Research Institute-San Dimas — San Dimas, California, United States (enrolling)
- Kidney & Hypertension Center - Apple Valley — Apple Valley, California, United States (enrolling)
- Applied Research Center of Arkansas — Little Rock, Arkansas, United States (enrolling)
- Provecta Research Network — Houston, Texas, United States (enrolling)
- R & H Clinical Research — Katy, Texas, United States (enrolling)
- CDC Research Institute, LLC — Port Saint Lucie, Florida, United States (enrolling)
- FOMAT Medical Research - FOMAT - PPDS — Oxnard, California, United States (enrolling)
- The Vasculitis and Glomerulonephritis Center at Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
- Nova Clinical Research, LLC — Bradenton, Florida, United States (enrolling)
- Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
- University of Florida - Gainesville - 1600 SW Archer Rd — Gainesville, Florida, United States (enrolling)
- Anointed Nephrology and HTN - SKYCRNG - PPDS — Brookhaven, Mississippi, United States (enrolling)
- Royal Research, Corp. — Hollywood, Florida, United States (enrolling)
- UCLA Health David Geffen School of Medicine — Los Angeles, California, United States (enrolling)
- James J Peters Veterans Administration Medical Center - NAVREF - PPDS — The Bronx, New York, United States (enrolling)
- Central Florida Kidney Specialists — Orlando, Florida, United States (enrolling)
- Lifespan at Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)
- Knoxville Kidney Center, PLLC — Knoxville, Tennessee, United States (enrolling)
- Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS — Buenos Aires, Argentina (enrolling)
Full record on ClinicalTrials.gov
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