A Real World Study About PMN (PMNTRWS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Membranous Nephropathy

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;

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Wei Chen; Phone Number: 8602087769673; Email: chenwei99@mail.sysu.edu.cn
• Study Contact Backup: Name: Qiong Wen; Phone Number: 8602087769673; Email: wenqiong@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Wei Chen
      • Contact: Qiong Wen; Phone Number: 8602087769673; Email: wenqiong@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed as primary membranous nephropathy (PMN) by renal biopsy, with indications for immunosuppressive therapy.

Description

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:

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.

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The complete response rate at 12 months	The complete response rate at 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response)	Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response)	24 months
Median remission time	Median remission time	24 months
Proportion of patients without recurrence at 12, 18 and 24 months	Proportion of patients without recurrence at 12, 18 and 24 months	24 months
Median non-recurrence time	Median non-recurrence time	24 months
Cumulative dose of glucocorticoids	Cumulative dose of glucocorticoids	24 months
CD19+ cell count, anti-PLA2R antibody expression level	CD19+ cell count, anti-PLA2R antibody expression level	24 months
Renal function index: eGFR	Renal function index: eGFR	24 months
Incidence of adverse events	Incidence of adverse events	24 months

Collaborators and Investigators

• Sponsor: Wei Chen

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Estimated): November 11, 2027
• Study Completion (Estimated): November 11, 2027

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Real-world Study
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Glomerulonephritis, Membranous
• Other Study ID Numbers: CR2023588-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No