eligibility_summary
Inclusion: Biopsy-confirmed active/chronic active AMR with no TCMR (Banff 2022), kidney transplant ≥6 months, HLA class I/II DSA-positive by single-antigen bead within 3 months. Exclusion: ABO-incompatible or multiple-organ/dual/en bloc transplants, rapid renal decline likely needing RRT in 30 days, recent AMR/TCMR therapies (IVIg/SCIg, PLEX, complement or proteasome inhibitors, tocilizumab) or investigational drugs, if 3–6 months prior, need biopsy+DSA ≥6 weeks post-therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests felzartamab vs placebo in kidney transplant recipients with late active/chronic active antibody-mediated rejection (AMR). Felzartamab is a fully human IgG1 monoclonal antibody targeting CD38, given by IV infusion. Mechanism: binds CD38 on antibody-secreting plasma cells and other CD38+ immune cells, inducing depletion via Fc-mediated cytotoxicity (ADCC, CDC, ADCP) and apoptosis. Intended effect: reduce donor-specific antibodies (DSA) and downstream humoral alloimmunity that drives AMR (including complement-mediated graft injury). Comparator: placebo (0.9% saline). Primary targeted cells/pathways: CD38+ long-lived plasma cells, B-lineage antibody production, DSA-driven humoral rejection pathway.