A Real World Study About PMN

Outcomes

• Primary objective Treatment of primary membranous nephropathy with conventional clinical protocols and observation of its effectiveness and safety in a wide population.
• Exploratory purpose

• Evaluate the genome-wide changes in kidney and peripheral blood during treatment.
• To evaluate the changes in the single-cell transcriptome of the kidney and peripheral blood during treatment.
• Evaluate the changes in the RNA transcriptome of the kidney and peripheral blood during treatment.
• Evaluate the changes in the renal and peripheral blood proteome during treatment.
• Assess the changes in the metabolome during treatment.
• Assess changes in the microbiome during treatment.
• Predict the effective population of rituximab by baseline renal pathological images.
• Primary outcome The complete response rate at 12 months;
• Secondary outcomes

• Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response);
• Median remission time;
• Proportion of patients without recurrence at 12, 18 and 24 months;
• Median non-recurrence time;
• Cumulative dose of glucocorticoids;
• CD19+ cell count, anti-PLA2R antibody expression level;
• Renal function index: eGFR;
• Incidence of adverse events;

Inclusion criteria

• Diagnosed as primary membranous nephropathy (PMN) by renal biopsy; 2. Aged over 18 years; 3. An average 24-hour urine protein ≥ 3.5g twice a week after treatment with ACE inhibitors or ARBs for at least 3 months.

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Exclusion criteria

• With secondary membranous nephropathy (such as hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes);
• Active infection, such as active hepatitis B or hepatitis C, tuberculosis (evidence of active tuberculosis infection within 1 year), or human immunodeficiency virus HIV infection (positive for anti-HIV antibodies), etc.
• A history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or organ transplantation.

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