eligibility_summary
Eligible: adults ≥18, ≥180 days post living or deceased donor kidney transplant, eGFR ≥30, with preformed or de novo DSA. Exclude: other trials, pregnancy/no contraception, ABO-incompatible graft, biopsy showing TCMR, severe TMA, or polyomavirus, anti-rejection or immunomodulatory biologics within 3 months, significant liver enzyme elevation, anemia/cytopenias, or IgG <400 mg/dL, active infection (incl TB, HBV), malignancy, live vaccine ≤6 weeks, substance abuse, serious illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05913596 evaluates daratumumab monotherapy for chronic active antibody‑mediated rejection (CaAMR) after kidney transplant. Daratumumab is a human IgG1 anti‑CD38 monoclonal antibody (immunotherapy) dosed 16 mg/kg every 2 weeks ×12, alongside standard prednisone+mycophenolate+calcineurin inhibitor. Mechanism: binds CD38 on plasma cells and NK cells, depleting them via ADCC, CDC, ADCP, and apoptosis, and inhibiting CD38 ectoenzyme activity. Targets/pathways: long‑lived plasma cells producing donor‑specific antibodies (DSA) and NK cells involved in AMR, aims to suppress humoral alloimmunity, reduce DSA, and lessen complement/Fc‑receptor–mediated graft injury.