Primary Membranous Nephropathy
Conditions
Keywords
Real-world Study
Brief summary
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.
Detailed 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 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;
Interventions
None listed
Sponsors
Wei Chen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. 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. \-
Exclusion criteria
1. With secondary membranous nephropathy (such as hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes); 2. 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. 3. A history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or organ transplantation. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The complete response rate at 12 months | 12 months | The complete response rate at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median remission time | 24 months | Median remission time |
| Proportion of patients without recurrence at 12, 18 and 24 months | 24 months | Proportion of patients without recurrence at 12, 18 and 24 months |
| Median non-recurrence time | 24 months | Median non-recurrence time |
| Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response) | 24 months | Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response) |
| CD19+ cell count, anti-PLA2R antibody expression level | 24 months | CD19+ cell count, anti-PLA2R antibody expression level |
| Renal function index: eGFR | 24 months | Renal function index: eGFR |
| Incidence of adverse events | 24 months | Incidence of adverse events |
| Cumulative dose of glucocorticoids | 24 months | Cumulative dose of glucocorticoids |
Countries
China
Contacts
Primary ContactWei Chen
Backup ContactQiong Wen
Outcome results
None listed