eligibility_summary
Include: Mayo biopsy–confirmed PGNMID, proteinuria ≥1 g/24h, CrCl ≥20 mL/min, consent, strict contraception with pregnancy tests, no gamete donation. Exclude: pregnancy, HIV, HBV (incl resolved, vax-only ok) or HCV unless SVR, multiple myeloma, severe lab abn, COPD FEV1<50%, moderate/severe or uncontrolled asthma, cardiac disease, prior anti‑CD38, recent research therapy/RT, recent steroids/immunosuppressants, CD20<20 after rituximab, live vaccines <4 wks, malignancy <2 yrs (exceptions).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm, open-label trial testing subcutaneous daratumumab for proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID). Intervention: Daratumumab 1800 mg SC (weekly ×8, then every 2 weeks ×8). Drug/mechanism: Daratumumab is a human IgG1κ monoclonal antibody (immunotherapy) targeting CD38. It depletes CD38+ plasma cells via antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP), and apoptosis, with additional immunomodulatory effects. Cells/pathways targeted: CD38-expressing clonal plasma cells (and related B-lineage cells) driving monoclonal IgG production and glomerular deposition, aims to reduce humoral immune activity and resultant complement-mediated glomerular injury to induce renal remission.