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

Launched by BIOGEN · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called felzartamab for kidney transplant recipients who are experiencing a specific type of rejection known as antibody-mediated rejection (AMR). The goal is to see if felzartamab is more effective than a placebo (a substance with no active treatment) for patients who have had a kidney transplant for at least six months and have been diagnosed with either active or chronic AMR. The trial is currently looking for participants aged 18 to 75 who have certain types of antibodies present that may cause rejection.

To be eligible for this trial, participants must have a confirmed diagnosis of AMR based on a biopsy and must not have had certain treatments for their kidney rejection in the past few months. During the trial, participants will receive either felzartamab or a placebo and be monitored closely for their kidney function and overall health. This research is important as it seeks to improve treatment options for patients facing complications after kidney transplants.

Gender

ALL

Eligibility criteria

• Key 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:
• • 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. e. Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization.
• • Other protocol-defined inclusion/exclusion criteria apply.