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 (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

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
Michigan
University of Michigan
RECRUITING
Ann Arbor
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
Royal Melbourne Hospital
RECRUITING
Parkville Vic
Westmead Hospital
RECRUITING
Sydney
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
Medical University of Vienna
RECRUITING
Spitalgasse
Brazil
Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer
RECRUITING
Centro Histórico
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
Hospital de Base da Faculdade de Medicina de São José do Rio Preto
RECRUITING
Vila São José
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
Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
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
Hospital Universitario de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
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

This content was sourced from clinicaltrials.gov