Actively Recruiting
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)
Led by Biogen · Updated on 2026-03-12
120
Participants Needed
59
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, researchers will learn more about the use of felzartamab in kidney transplant patients who have antibody-mediated rejection, also known as AMR. Kidney transplants can save lives for people with kidney failure. But even after a successful transplant, the body's immune system can sometimes attack the new kidney. Antibody-mediated rejection (AMR) is when a person's immune system attacks a transplanted organ, like a new kidney. In the person receiving the transplant, their immune system creates specific antibodies. Antibodies are proteins that help the body fight infections. In people with AMR, these antibodies mistakenly see the new organ as a threat and damage its blood vessels. This can cause the new organ to fail. In this study, researchers will learn more about how a study drug called felzartamab affects people with AMR. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce antibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works in participants with kidney transplants who experience AMR compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug. All participants in this study will have active AMR or AMR that has lasted for at least 6 months after their kidney transplant. The main question that researchers want to answer is: • How many participants have biopsy results showing that their transplanted kidney tissue looks normal or near normal after 24 weeks of treatment? Researchers will also learn about: * How long it takes before the participants' disease gets worse * How long the participants' urine protein levels stay low * Kidney biopsy scores to check for blood vessel inflammation at 6 months and 1 year * How many people have no blood vessel inflammation at these times * Changes in donor deoxyribonucleic acid (DNA) levels in blood from the start of treatment * Biopsy test scores for signs of rejection and inflammation at 6 months and 1 year * Changes in kidney function from the start of treatment * How many people have biopsy results showing their kidney tissue looks normal again * How long the transplanted kidney keeps working * How many participants have medical problems during the study * How many participants show signs of another type of kidney transplant rejection called T-cell-mediated rejection (TCMR) at Week 24 and Week 52 * How do results from vital signs, electrocardiograms (ECGs), and blood and urine tests change over time * How felzartamab is processed by the body * How many participants develop antibodies against felzartamab in the blood The study will be done as follows: * Participants will be screened to check if they can join the study. This will take up to 42 days. * There will be 2 parts in this study. * Part A of the study is "double blind." This means that neither the participants, study doctor, or site staff know if the participants received the study drug or a placebo. During Part A, participants will be randomized to receive up to 9 doses of either felzartamab or placebo. * Part B of the study is "open label." This means that the participants, study doctor, and site staff know which study drug the participant is receiving. During Part B, all participants from Part A will receive up to 9 doses of felzartamab. * All doses will be given through an "intravenous" infusion. This means it will be given into a vein. The dose the participants receive will depend on their body weight. * Part A will last up to 24 weeks. Part B will last up to 28 weeks. In total, participants will have up to 21 study visits and will be in the study for about 1 year.
CONDITIONS
Official Title
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-confirmed active or chronic active antibody-mediated rejection (AMR) without T-cell mediated rejection
- Kidney transplant performed at least 6 months before screening
- Positive for donor-specific antibodies (HLA Class I and/or II) 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
- Acute rapid decline in kidney function likely requiring dialysis within 30 days
- Treatment for AMR or T-cell mediated rejection with certain therapies (except corticosteroids) within 3 months before randomization
- Use of intravenous or subcutaneous immunoglobulin, plasma exchange, complement inhibitors, proteasome inhibitors, tocilizumab, B cell-depleting therapies, or investigational agents within specified timeframes before randomization
AI-Screening
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Trial Site Locations
Total: 59 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
4
Providence Healthcare
Orange, California, United States, 92868
Actively Recruiting
5
Loma Linda
San Bernardino, California, United States, 92408
Actively Recruiting
6
California Pacific Medical Center
San Francisco, California, United States, 94109
Actively Recruiting
7
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
8
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
9
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
10
University of Kansas
Kansas City, Kansas, United States, 66160
Actively Recruiting
11
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
12
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
13
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
14
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
15
University of Nebraska
Omaha, Nebraska, United States, 68198-5331
Actively Recruiting
16
Cooperman Barnabas Medical Center
West Orange, New Jersey, United States, 07039
Actively Recruiting
17
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
18
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
19
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
20
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
21
Penn Medicine - Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
22
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
23
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
24
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
25
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
26
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
27
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
28
Instituto de Trasplante y Alta Complejidad (ITAC)
Cdad, Autónoma de Buenos Aires, Argentina, C1425 C1425EGH
Actively Recruiting
29
Clinica Privada Velez Sarsfield
Córdoba, Argentina, X5000
Actively Recruiting
30
Royal Melbourne Hospital
Parkville VIC, Australia, Australia, 3050
Actively Recruiting
31
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Actively Recruiting
32
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
33
Princess Alexandra Hospital
Woolloongabba, Australia, QLD 4102
Actively Recruiting
34
Medical University of Vienna
Spitalgasse, State of Vienna, Austria, 1090
Actively Recruiting
35
Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer
Centro Histórico, Porto Alegre - RS, Brazil, 90020-090
Actively Recruiting
36
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
37
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Cerqueira César, São Paulo, Brazil, 05403-010
Actively Recruiting
38
Fundação Oswaldo Ramos - Hospital do Rim (HRIM)
Vila Clementino, São Paulo, Brazil, 04038-002
Actively Recruiting
39
University of Alberta
Edmonton, Alberta, Canada, T6G 2C8
Actively Recruiting
40
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
41
The University of British Columbia (UBC)/St. Paul's Hospital part of Providence Health Care
Vancouver, British Columbia, Canada, V6T 1Z3
Actively Recruiting
42
McGill University
Montreal, Quebec, Canada, H3G 1A4
Actively Recruiting
43
Institute for Clinical and Experimental Medicine (IKEM)
Czechia, Praha 4, Czechia, 14021
Actively Recruiting
44
CHU Lyon Hôpital Edouard Herriot
Bordeaux, France, 32000
Actively Recruiting
45
CHU Grenoble Alpes Hôpital Michallon
La Tronche, France, 38700
Actively Recruiting
46
Hospices Civils de Lyon - Hôpital Édouard Herriot
Lyon, France, 69003
Actively Recruiting
47
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil
Toulouse, France, 31400
Actively Recruiting
48
Charite University
Berlin, Germany, 10117
Actively Recruiting
49
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 1307
Actively Recruiting
50
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
51
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Actively Recruiting
52
Auckland City Hospital
Grafton, Auckland, New Zealand, 1023
Actively Recruiting
53
Hospital Clinic de Barcelona
Calle Villarroel, Barcelona, Spain, 8036
Actively Recruiting
54
Hospital del Mar
Ciutat Vella, Barcelona, Spain, 8003
Actively Recruiting
55
Hospital Universitario Vall d'Hebron
Horta-Guinardó, Barcelona, Spain, 8035
Actively Recruiting
56
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 8907
Actively Recruiting
57
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
58
University Hospital Basel
Petersgraben, Basel, Switzerland, 4031
Actively Recruiting
59
Universitätsspital Zürich
Zurich, Switzerland, 8091
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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