A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)
Status: Recruiting
Location: See all (48) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main goal of this trial is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with late active or chronic active AMR.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Active or chronic active AMR (biopsy-confirmed) without TCMR per central reading, as defined by the Banff 2022 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.
Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
UCLA
RECRUITING
Los Angeles
University of Southern California
RECRUITING
Los Angeles
Providence Healthcare
RECRUITING
Orange
Loma Linda
RECRUITING
San Bernardino
California Pacific Medical Center
RECRUITING
San Francisco
University of California, San Francisco
RECRUITING
San Francisco
Colorado
University of Colorado
RECRUITING
Aurora
Illinois
University of Chicago
RECRUITING
Chicago
Kansas
University of Kansas
RECRUITING
Kansas City
Louisiana
Tulane University Health Sciences Center
RECRUITING
New Orleans
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
Washington University
RECRUITING
St Louis
North Carolina
Duke University
RECRUITING
Durham
Nebraska
University of Nebraska
RECRUITING
Omaha
New Jersey
Cooperman Barnabas Medical Center
RECRUITING
West Orange
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
The Ohio State University
RECRUITING
Columbus
Pennsylvania
Penn Medicine - Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Vanderbilt University
RECRUITING
Nashville
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Houston Methodist
RECRUITING
Houston
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Washington
University of Washington Medical Center
RECRUITING
Seattle
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Fiona Stanley Hospital
RECRUITING
Murdoch
Westmead Hospital
RECRUITING
Sydney
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
Medical University of Vienna
RECRUITING
Spitalgasse
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
RECRUITING
Cerqueira César
Fundação Oswaldo Ramos - Hospital do Rim (HRIM)
RECRUITING
Vila Clementino
Canada
University of Alberta
RECRUITING
Edmonton
McGill
NOT_YET_RECRUITING
Montreal
The University of British Columbia (UBC)/St. Paul's Hospital part of Providence Health Care
RECRUITING
Vancouver
Vancouver General Hospital
RECRUITING
Vancouver
France
CHU Lyon Hôpital Edouard Herriot
RECRUITING
Bordeaux
CHU Grenoble Alpes Hôpital Michallon
RECRUITING
La Tronche
Hospices Civils de Lyon - Hôpital Édouard Herriot
RECRUITING
Lyon
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil
RECRUITING
Toulouse
Germany
Charite University
RECRUITING
Berlin
Universitatsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
New Zealand
Auckland City Hospital
RECRUITING
Grafton
Spain
Hospital Clinic de Barcelona
RECRUITING
Calle Villarroel
Hospital del Mar
RECRUITING
Ciutat Vella
Hospital Universitario Vall d'Hebron
RECRUITING
Horta-guinardó
Switzerland
University Hospital Basel
RECRUITING
Petersgraben
Universitätsspital Zürich
RECRUITING
Zurich
Contact Information
Primary
US Biogen Clinical Trial Center
clinicaltrials@biogen.com
1-866-633-4636
Backup
Global Biogen Clinical Trial Center
clinicaltrials@biogen.com
Time Frame
Start Date: 2024-12-03
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 120
Treatments
Experimental: Felzartamab
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Biogen