A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)

Open to people ages 18-75

• 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 (pre-formed and/or de novo DSA) as determined by the local laboratory's definition of positivity using single-antigen bead-based assays within 6 months prior to randomization.

• 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:
  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.
  5. Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization.

Other protocol-defined inclusion/exclusion criteria apply.