Clinical trial NCT06893328: A Real World Study About PMN
Official title: PMNTRWS: A Non-interventional Study on Treatment and Therapeutic Efficacy in Chinese Patients With Primary Membranous Nephropathy (PMNTRWS)"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Membranous Nephropathy
Keywords: Real-world Study
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed as primary membranous nephropathy (PMN) by renal biopsy, with indications for immunosuppressive therapy.

Brief summary: We 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, we 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;

Eligibility criteria: Inclusion Criteria:

1.Men and Women aged over 18 years; 2.Patients diagnosed as primary membranous nephropathy (PMN) by renal biopsy; 3.After treatment with ACE inhibitors or ARBs for at least 3 months, those who have an average 24-hour urine protein ≥ 3.5g twice a week.

-

Exclusion Criteria:

1. Patients 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.

   -

Primary outcomes:
measure: The complete response rate at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response)
timeFrame: 24 months
measure: Median remission time
timeFrame: 24 months
measure: Proportion of patients without recurrence at 12, 18 and 24 months
timeFrame: 24 months
measure: Median non-recurrence time
timeFrame: 24 months
measure: Cumulative dose of glucocorticoids
timeFrame: 24 months
measure: CD19+ cell count, anti-PLA2R antibody expression level
timeFrame: 24 months
measure: Renal function index: eGFR
timeFrame: 24 months
measure: Incidence of adverse events
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Wei Chen
state: Guangdong
Study officials:
References: