This was a prospective, randomized, multicenter clinical trial. Seventy-eight patients with primary membranous nephropathy (PMN) were randomly divided into intervention or control group. Intervention group was given rituximab combined with corticosteroids in induction therapy and the control group was given rituximab monotherapy. After 6 months, patients who had decreased 24h urinary protein by \> 25% but did not achieve CR were given rituximab maintenance therapy. The complete response rate at 12 months was measured.
Men and women aged 18-75 years;
Patients diagnosed as primary membranous nephropathy (PMN) by renal biopsy;
Patients with type 1 diabetes mellitus or type 2 diabetes mellitus complicated with diabetic nephropathy. Patients with a recent history of steroid-induced diabetes were eligible if renal biopsies show no evidence of secondary diabetic nephropathy within 6 months before the screening period
Patients with secondary membranous nephropathy (such as hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes);
Previous treatment with rituximab, steroids, alkylating agents, calcineurin inhibitors, synthetic ACTH, mycophenolate (MMF), and azathioprine;
Receipt of any other study medication (within the last month);
Parallel
rituximab combined with corticosteroids
DrugInduction therapy: Rituximab intravenous infusion of 1g, d1, d15, combined with glucocorticoid therapy, oral prednisolone, initial dose of 0.5mg/(kg·d), once a day, after 8 weeks of treatment, reduce by 5mg every 4 weeks until 0.25mg/kg, this dose was maintained for 8 weeks, and then reduced by 2.5mg every 4 weeks, until 5-10mg is maintained, and the total course of treatment was about one year or so;
rituximab
DrugControl group (treated with Rituximab monotherapy treatment) :Rituximab intravenous infusion of 1g, d1, d15
The complete response rate at 12 months;
The complete response rate at 12 months;
Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response);
Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response);
Median remission time;
Median remission time;
Proportion of patients without recurrence at 12, 18 and 24 months;
Proportion of patients without recurrence at 12, 18 and 24 months;
Median non-recurrence time;
Median non-recurrence time;
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