This is a multiple-center, prospective, open-label, positive drug controlled, randomized, clinical study to evaluate the safety and efficacy of Telitacicept in the treatment of primary membranous nephropathy.
Patients must have a confirmed diagnosis of primary membranous nephropathy through renal biopsy to be eligible for inclusion in the study.
Adult patients aged 18 years or older of any gender are eligible for inclusion in the study.
Patients who meet the diagnostic criteria for nephrotic syndrome, which includes quantitative urine protein levels greater than 3.5 g/24 h and serum albumin levels less than 30 g/L, are eligible for inclusion in the study.
Patients who meet the high-risk criteria for progression of membranous nephropathy based on the KDIGO (Kidney Disease: Improving Global Outcomes) guidelines are eligible for inclusion in the study. High-risk criteria include eGFR less than 60 mL/min/1.73 m2 and/or urine protein excretion greater than 8 g/day for at least 6 months, or normal eGFR with urine protein excretion greater than 3.5 g/day and urine protein reduction less than 50% after 6 months of ACEI/ARB treatment, with any of the following criteria: serum albumin less than 25 g/L, anti-PLA2R antibody greater than 50 RU/mL, urine α1-microglobulin greater than 40 μg/min, urine IgG1 greater than 1 μg/min, urine β2-microglobulin greater than 250 mg/day, and SI greater than 0.2.
Secondary membranous nephropathy patients (caused by autoimmune or infectious diseases, tumors, etc.);
Patients with HIV infection, viral hepatitis, active liver disease (with ALT/AST/bilirubin levels exceeding 3 times the upper limit of normal), or other severe infections;
Patients with a rapid decline in eGFR (>15 mL/min) during the screening period are excluded;
Patients who have undergone kidney transplantation or other organ transplantation;