Phase
Condition
Nephritis
Transplant Rejection
Treatment
Felzartamab
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Active or chronic active AMR (biopsy-confirmed) without TCMR per central reading, asdefined by the Banff 2022 criteria.
Kidney transplant at least 6 months prior to Screening visit (recipients of eitherliving or deceased donors).
Donor-specific antibody (DSA): Human leukocyte antigen (HLA) Class I and/or IIantigen-specific DSA-positive (preformed and/or de novo DSA) as determined by thelocal laboratory's definition of positivity using single-antigen bead-based assayswithin 3 months prior to randomization.
Exclusion
Key Exclusion Criteria:
Transplant: Blood type (ABO)-incompatible transplant.
History of multiple organ transplants including en bloc and dual kidney transplants.
Acute, rapid decline in renal function, defined as a participant likely to requirerenal replacement therapy within the subsequent 30 days as determined by theInvestigator.
Treatment: Prior AMR/TCMR treatment (with the exception of corticosteroids) within 3months prior to randomization is excluded as listed below. Participants who receivedany of these treatments between 3 and 6 months prior to randomization must have botha 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:
Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin [SCIg]) or PLEX.
Complement system inhibitors (e.g., eculizumab).
Proteasome inhibitors (e.g., bortezomib).
Tocilizumab.
Any other investigational agent within 3 months or 5 half-lives (whichever islonger) of randomization.
Other protocol-defined inclusion/exclusion criteria apply.
Study Design
Study Description
Connect with a study center
Biogen West Investigational Site
Los Angeles, California 90095
United StatesActive - Recruiting
UCLA
Los Angeles, California 90095
United StatesActive - Recruiting
University of Southern California
Los Angeles, California 90033
United StatesActive - Recruiting
Providence Healthcare
Orange, California 92868
United StatesActive - Recruiting
California Pacific Medical Center
San Francisco, California 94109
United StatesActive - Recruiting
Biogen West Investigational Site
Omaha, Nebraska 68105
United StatesSite Not Available
University of Nebraska
Omaha, Nebraska 68198-5331
United StatesActive - Recruiting
Biogen West Investigational Site
Livingston, New Jersey 07039
United StatesSite Not Available
Cooperman Barnabas Medical Cent
West Orange, New Jersey 07039
United StatesActive - Recruiting
Cooperman Barnabas Medical Center
West Orange, New Jersey 07039
United StatesActive - Recruiting
Biogen West Investigational Site
Columbus, Ohio 43201
United StatesSite Not Available
The Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
Penn Medicine - Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Biogen West Investigational Site
Nashville, Tennessee 37232
United StatesSite Not Available
Biogen West Investigational Site
Richmond, Virginia 23298
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23298
United StatesActive - Recruiting
Biogen West Investigational Site
Seattle, Washington 98195
United StatesSite Not Available
University of Washington Medical Center
Seattle, Washington 98195
United StatesActive - Recruiting
Biogen West Investigational Site
Madison, Wisconsin 53226
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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