Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001
Primary Membranous Nephropathy
About this trial
This is an interventional treatment trial for Primary Membranous Nephropathy
Eligibility Criteria
Inclusion Criteria: Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy. Have positive anti-PLA2R autoantibody test results > 20 relative units (RU)/ml AND < 150RU/ml at screening. During screening at least one testing of proteinuria must be >3.5 g/24h. Have nephrotic range proteinuria for at least 3 months prior to Day 1 and no improvement despite supportive therapy of ACE inhibitor or ARB unless contraindicated. Exclusion Criteria: Non-primary membranous nephropathy or other condition affecting the kidney. eGFR at screening < 60 mL/min/1.73m2 or kidney function not stable . Uncontrolled hypertension . Serum albumin level at screening ≤ 25g/l. Have received: B-cell targeted therapy except rituximab at any time; Rituximab and the biosimilars within 2 years (participants with rituximab treatment between 1 and 2 years prior to Day 1 are eligible if there is documented evidence of B-cell repopulation to >90% of Lower Limits of Normal Range.); Cyclophosphamide or Chlorambucil within 180 days; immunosuppressive/immunomodulatory agents within 90 days. Acute or chronic infection. Positive serology for HIV, HBV, or HCV. Lab testing abnormality as: WBC< 3000/mm³, Lymphocyte < 1000/mm³, neutrophil <1500/mm³, Hb < 80g/L, Platelet count <100×10e9/L, Prothrombin time>1.5×ULN, Activated partial thromboplastin time ≥ 1.5×ULN. Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
Sites / Locations
Arms of the Study
Arm 1
Experimental
EVER001
EVER001 for 36 weeks.