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A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Sponsor: Biogen
Summary
In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. It can lead to serious kidney problems over time. In many cases, MVI is caused by antibodies that attack the transplanted kidney. But in some people, MVI happens without these antibodies. This type of MVI is called isolated MVI. There are currently no approved treatments for isolated MVI. The main goal of the study is to learn about the effect felzartamab has on inflammation in the transplanted kidney. The main question researchers want to answer is: • How many participants have no signs of active inflammation in the transplanted kidney after 24 weeks of treatment with felzartamab? Researchers will also study how felzartamab affects kidney function, immune activity, and overall health. They will monitor safety through kidney biopsies, lab tests, and by recording adverse events throughout the study. Adverse events are health problems that may or may not be caused by the study drug. The study will be done in 2 parts as follows: * Participants will be randomly assigned to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine. * In Part A, participants will receive their assigned drug for 24 weeks. Neither the researchers nor the participants will know who is receiving felzartamab or placebo. * Part B will last another 28 weeks. All participants will receive felzartamab and both participants and researchers will know this. * All treatments will be given by intravenous (IV) infusion at the study site. * Participants will have kidney biopsies at the start of the study, at Week 24, and at Week 52 to help measure changes in inflammation. * Participants will stay in the study for about 1 year.
Official title: A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants With Late Isolated Microvascular Inflammation (MVI)
Key Details
Gender
All
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
81
Start Date
2026-01-05
Completion Date
2028-02-10
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
Felzartamab
Administered IV
Placebo
Administered IV
Locations (15)
Keck Hispital of University of Southern California (USC)
Los Angeles, California, United States
Providence St. Joseph Hospital Orange
Orange, California, United States
Sutter Health - California Pacific Medical Center
San Francisco, California, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cooperman Barnabas Medical Center
West Orange, New Jersey, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
University of Washington Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Medizinische Universität Wien
Vienna, Austria
Hospital de Base da Faculdade de Medicina de São José do Rio Preto
Vila São José, São José Do Rio Preto, Brazil
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Hospital Universitario Vall d'Hebron
Barcelona, Spain