A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)
NCT ID: NCT06685757
Last Updated: 2025-11-12
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2024-12-03
2027-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Felzartamab
Felzartamab
Participants will receive felzartamab by intravenous infusion.
Placebo
Placebo
Participants will receive 0.9% saline solution by intravenous infusion.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Felzartamab
Participants will receive felzartamab by intravenous infusion.
Placebo
Participants will receive 0.9% saline solution by intravenous infusion.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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. e. Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biogen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
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
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 Miguel Servet
Zaragoza, , Spain
University Hospital Basel
Petersgraben, Basel, Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-519095-66-00
Identifier Type: CTIS
Identifier Source: secondary_id
299AR301
Identifier Type: -
Identifier Source: org_study_id