NCT06893328

A Real World Study About PMN

PMNTRWS: A Non-interventional Study on Treatment and Therapeutic Efficacy in Chinese Patients With Primary Membranous Nephropathy (PMNTRWS)"

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Wei Chen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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;

Conditions

• Primary Membranous Nephropathy

Timeline

• Start date: 2024-11-11
• Primary completion: 2027-11-11
• Completion: 2027-11-11
• First posted: 2025-03-25
• Last updated: 2025-08-22

Locations

1 site across 1 country: China