A Real World Study About PMN
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Membranous Nephropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PMNTRWS: A Non-interventional Study on Treatment and Therapeutic Efficacy in Chinese Patients With Primary Membranous Nephropathy (PMNTRWS)"
Overview
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;
Primary outcome measures
- The complete response rate at 12 months [Time frame: 12 months]
Secondary outcome measures (8)
- 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 [Time frame: 24 months]
- Proportion of patients without recurrence at 12, 18 and 24 months [Time frame: 24 months]
- Median non-recurrence time [Time frame: 24 months]
- Cumulative dose of glucocorticoids [Time frame: 24 months]
- CD19+ cell count, anti-PLA2R antibody expression level [Time frame: 24 months]
- Renal function index: eGFR [Time frame: 24 months]
- Incidence of adverse events [Time frame: 24 months]
Eligibility criteria
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.
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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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Wei Chen — Guangzhou
Identifiers
NCT: NCT06893328 · CR2023588-1