A Real World Study About PMN

Last updated: August 18, 2025
Sponsor: Wei Chen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nephrotic Syndrome

Glomerulonephritis

Idiopathic Membranous Nephropathy

Treatment

N/A

Clinical Study ID

NCT06893328
CR2023588-1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. With secondary membranous nephropathy (such as hepatitis B and C, systemic lupuserythematosus, drug therapy, malignant tumors and other secondary causes);

  2. Active infection, such as active hepatitis B or hepatitis C, tuberculosis (evidenceof active tuberculosis infection within 1 year), or human immunodeficiency virus HIVinfection (positive for anti-HIV antibodies), etc.

  3. A history of immunodeficiency, including other acquired or congenitalimmunodeficiency diseases, or organ transplantation.

Study Design

Total Participants: 200
Study Start date:
November 11, 2024
Estimated Completion Date:
November 11, 2027

Study 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;

Connect with a study center

  • Wei Chen

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Wei Chen

    Guangzhou 1809858, Guangdong 1809935 510080
    China

    Active - Recruiting

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