The investigators 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, the investigators 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.
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 1. Evaluate the genome-wide changes in kidney and peripheral blood during treatment. 2. To evaluate the changes in the single-cell transcriptome of the kidney and peripheral blood during treatment. 3. Evaluate the changes in the RNA transcriptome of the kidney and peripheral blood during treatment. 4. Evaluate the changes in the renal and peripheral blood proteome during treatment. 5. Assess the changes in the metabolome during treatment. 6. Assess changes in the microbiome during treatment. 7. Predict the effective population of rituximab by baseline renal pathological images. * Primary outcome The complete response rate at 12 months; * Secondary outcomes 1. Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response); 2. Median remission time; 3. Proportion of patients without recurrence at 12, 18 and 24 months; 4. Median non-recurrence time; 5. Cumulative dose of glucocorticoids; 6. CD19+ cell count, anti-PLA2R antibody expression level; 7. Renal function index: eGFR; 8. Incidence of adverse events;
Study Type
OBSERVATIONAL
Enrollment
200
Wei Chen
Guangzhou, Guangdong, China
RECRUITINGThe complete response rate at 12 months
The complete response rate at 12 months
Time frame: 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)
Time frame: 24 months
Median remission time
Median remission time
Time frame: 24 months
Proportion of patients without recurrence at 12, 18 and 24 months
Proportion of patients without recurrence at 12, 18 and 24 months
Time frame: 24 months
Median non-recurrence time
Median non-recurrence time
Time frame: 24 months
Cumulative dose of glucocorticoids
Cumulative dose of glucocorticoids
Time frame: 24 months
CD19+ cell count, anti-PLA2R antibody expression level
CD19+ cell count, anti-PLA2R antibody expression level
Time frame: 24 months
Renal function index: eGFR
Renal function index: eGFR
Time frame: 24 months
Incidence of adverse events
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Incidence of adverse events
Time frame: 24 months