eligibility_summary
Eligibility: Age ≥15 with biopsy‑proven idiopathic membranous nephropathy and nephrotic syndrome, UPCR ≥3.5 g/gCr, albumin ≤3.0 g/dL, no steroids/immunosuppressants in prior 12 weeks, consent. Exclude other/secondary NS, eGFR <30, prior anti‑CD20, recent/ongoing trials, renal transplant, HbA1c ≥8%, active infection, viral seropositivity (HBV/HCV/HIV/HTLV‑1), cytopenias, severe drug/murine allergy, life‑threatening NS, serious comorbidities, pregnancy/lactation or no contraception, investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05914155 (PRIME): Phase 3, multicenter, randomized, double-blind, placebo-controlled trial in idiopathic membranous nephropathy with nephrotic syndrome. Intervention: Rituximab (genetic recombination), a chimeric anti-CD20 monoclonal antibody (drug), 1,000 mg IV on Days 1 and 15, open-label rescue with the same dosing at Week 26 for nonresponders. Mechanism: depletes CD20+ B cells via complement-dependent cytotoxicity, ADCC, and apoptosis, reducing pathogenic autoantibodies (e.g., anti-PLA2R/THSD7A), limiting subepithelial immune complex deposition and complement activation on podocytes. Targets: CD20+ B lymphocytes (naïve/memory), humoral autoimmunity, complement-mediated podocyte/glomerular basement membrane injury. Comparator: placebo.