Actively Recruiting
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Led by Biogen · Updated on 2026-04-27
81
Participants Needed
23
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- MVI (MVI 652), donor specific antibody (DSA)-negative, biopsy-confirmed without T cell-mediated rejection (TCMR) per Banff 2022 criteria
- Biopsy within 3 months before randomization meeting adequate criteria (10 or more non-sclerotic glomeruli and 2 muscular arteries, or minimally adequate: at least 7 glomeruli and 1 artery)
- For prior treatment of antibody-mediated rejection or TCMR, biopsy done at least 6 weeks after treatment completion
- Kidney transplant received at least 6 months before screening
- Negative for HLA Class I and II donor specific antibodies within 3 months before randomization
You will not qualify if you...
- Blood type (ABO)-incompatible kidney transplant
- History of multiple organ transplants including en bloc and dual kidney transplants
- Presence of HLA donor-specific antibodies
- Acute rapid decline in kidney function likely requiring renal replacement therapy within 30 days
- Prior treatments for antibody-mediated rejection or T cell-mediated rejection within 3 months before randomization, including immunoglobulin, plasma exchange, complement inhibitors, proteasome inhibitors, anti-IL-6R, B cell-depleting therapies, or investigational agents
- Other protocol-defined exclusion criteria may apply
AI-Screening
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Trial Site Locations
Total: 23 locations
1
Keck Hispital of University of Southern California (USC)
Los Angeles, California, United States, 90033
Actively Recruiting
2
Providence St. Joseph Hospital Orange
Orange, California, United States, 92868
Actively Recruiting
3
Sutter Health - California Pacific Medical Center
San Francisco, California, United States, 94115
Actively Recruiting
4
University of California San Fransisco (UCSF) Medical Center
San Francisco, California, United States, 94158
Actively Recruiting
5
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
7
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
8
Cooperman Barnabas Medical Center
West Orange, New Jersey, United States, 07039
Actively Recruiting
9
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
10
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
11
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
12
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
13
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
14
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
15
Medizinische Universität Wien
Vienna, Austria, 1090
Actively Recruiting
16
Hospital de Base da Faculdade de Medicina de São José do Rio Preto
Vila São José, São José Do Rio Preto, Brazil, 15090-000
Actively Recruiting
17
Hospital do Rim - Fundação Oswaldo Ramos
São Paulo, Brazil, 04038-002
Actively Recruiting
18
Institut klinicke a experimentalni mediciny (IKEM)
Prague, Czechia, 104 21
Actively Recruiting
19
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil
Toulouse, France, 31400
Actively Recruiting
20
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
21
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20251
Actively Recruiting
22
Hospital Del Mar
Barcelona, Spain, 8003
Actively Recruiting
23
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 8035
Actively Recruiting
Research Team
U
US Biogen Clinical Trial Center
CONTACT
G
Global Biogen Clinical Trial Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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