A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)
NCT ID: NCT06685757
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2024-12-03
2027-06-01
Brief Summary
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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.
Detailed Description
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The secondary objectives of this study are: Part A: To evaluate the efficacy of felzartamab compared to placebo through additional clinical endpoints; Part B: To summarize felzartamab efficacy at Week 52 in kidney transplant recipients diagnosed with active or chronic active AMR; Parts A and B: To evaluate the safety of felzartamab in kidney transplant recipients diagnosed with active or chronic AMR and to assess the pharmacokinetic (PK) profile and immunogenicity of felzartamab.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Felzartamab
Felzartamab
Participants will receive felzartamab by intravenous infusion.
Placebo
Placebo
Participants will receive 0.9% saline solution by intravenous infusion.
Interventions
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Felzartamab
Participants will receive felzartamab by intravenous infusion.
Placebo
Participants will receive 0.9% saline solution by intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors).
* Donor-specific antibody (DSA): Human leukocyte antigen (HLA) Class I and/or II antigen-specific DSA-positive (preformed and/or de novo DSA) as determined by the local laboratory's definition of positivity using singleantigen bead-based assays within 3 months prior to randomization.
Exclusion Criteria
* History of multiple organ transplants including en bloc and dual kidney transplants.
* Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the subsequent 30 days as determined by the Investigator.
* Treatment: Prior AMR/TCMR treatment (with the exception of corticosteroids) within 3 months prior to randomization is excluded as listed below. Participants who received any of these treatments between 3 and 6 months prior to randomization must have both a renal biopsy (IC3) and DSA testing at least 6 weeks after completing (or stopping) treatment in order to confirm continuing AMR and to determine eligibility:
1. Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or PLEX.
2. Complement system inhibitors (e.g., eculizumab).
3. Proteasome inhibitors (e.g., bortezomib).
4. Tocilizumab.
5. Any B cell-depleting therapy (including anti-Cluster of Differentiation 20 \[CD20\] agents \[e.g., rituximab\]) within 3 months prior to randomization.
6. Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization.
18 Years
75 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Providence Healthcare
Orange, California, United States
Loma Linda
San Bernardino, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas
Kansas City, Kansas, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Cooperman Barnabas Medical Center
West Orange, New Jersey, United States
Duke University
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Penn Medicine - Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal Melbourne Hospital
Parkville VIC, Australia, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Medical University of Vienna
Spitalgasse, Vienna, Austria
Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer
Centro Histórico, Porto Alegre - RS, Brazil
Hospital de Base da Faculdade de Medicina de São José do Rio Preto
Vila São José, São José Do Rio Preto, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Cerqueira César, São Paulo, Brazil
Fundação Oswaldo Ramos - Hospital do Rim (HRIM)
Vila Clementino, São Paulo, Brazil
University of Alberta
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
The University of British Columbia (UBC)/St. Paul's Hospital part of Providence Health Care
Vancouver, British Columbia, Canada
McGill University
Montreal, Quebec, Canada
CHU Lyon Hôpital Edouard Herriot
Bordeaux, , France
CHU Grenoble Alpes Hôpital Michallon
La Tronche, , France
Hospices Civils de Lyon - Hôpital Édouard Herriot
Lyon, , France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil
Toulouse, , France
Charite University
Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Auckland City Hospital
Grafton, Auckland, New Zealand
Hospital Clinic de Barcelona
Calle Villarroel, Barcelona, Spain
Hospital del Mar
Ciutat Vella, Barcelona, Spain
Hospital Universitario Vall d'Hebron
Horta-Guinardó, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
University Hospital Basel
Petersgraben, Basel, Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-519095-66-00
Identifier Type: CTIS
Identifier Source: secondary_id
299AR301
Identifier Type: -
Identifier Source: org_study_id