Overview
We designed a randomized, controlled, multicenter clinical study to compare the efficacy and safety of rituximab combined with hormones versus rituximab monotherapy in the treatment of primary membranous nephropathy. At the same time, we conducted a real-world study on patients who did not meet the inclusion and exclusion criteria or were unwilling to enter the RCT cohort, to further observe the trial results in a broader population.
Description
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;
Eligibility
Inclusion Criteria:
1.Men and Women aged over 18 years; 2.Patients diagnosed as primary membranous nephropathy (PMN) by renal biopsy; 3.After treatment with ACE inhibitors or ARBs for at least 3 months, those who have an average 24-hour urine protein ≥ 3.5g twice a week.
- Exclusion Criteria:
- Patients 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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