A Real World Study About PMN (PMNTRWS)

Wei Chen

Status: Enrolling

Conditions: Primary Membranous Nephropathy

Study type: Observational

Funder types: Other

Identifiers

NCT06893328

CR2023588-1

Details and patient eligibility

About

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.

Full 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;

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.