StudyFinder
A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)
RECRUITING
18 years to 75 years old
Key
• Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or PLEX.
• Complement system inhibitors (e.g., eculizumab).
• Proteasome inhibitors (e.g., bortezomib).
• Tocilizumab. e. Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization. Other protocol-defined inclusion/exclusion criteria apply.
Inclusion Criteria:
* 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.
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 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:
• Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or PLEX.
• Complement system inhibitors (e.g., eculizumab).
• Proteasome inhibitors (e.g., bortezomib).
• Tocilizumab. e. Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization. Other protocol-defined inclusion/exclusion criteria apply.
DRUG: Felzartamab, DRUG: Placebo
Antibody-mediated Rejection
AMR, Felzartamab, Kidney Transplant
US Biogen Clinical Trial Center - clinicaltrials@biogen.com
PHASE3
NCT06685757