A Real World Study About PMN

NCT06893328 | Recruiting DMC

• 1 other identifier: CR2023588-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Membranous Nephropathy

Keywords

Real-world Study

Outcome Measures

Primary Outcomes (1)

• The complete response rate at 12 months

  The complete response rate at 12 months

  12 months

Secondary Outcomes (8)

• 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

  24 months

• Proportion of patients without recurrence at 12, 18 and 24 months

  24 months

• Median non-recurrence time

  24 months

• Cumulative dose of glucocorticoids

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \. 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.

You may not qualify if:

• With secondary membranous nephropathy (such as hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes);
• 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.
• A history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or organ transplantation.

Sponsors & Collaborators

• Wei Chen: lead

Study Sites (1)

Wei Chen

Guangzhou, Guangdong, 510080, China

RECRUITING

Central Study Contacts

Wei Chen

CONTACT

8602087769673; chenwei99@mail.sysu.edu.cn

Qiong Wen

CONTACT

8602087769673; wenqiong@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: November 11, 2024
• Primary Completion (Estimated): November 11, 2027
• Study Completion (Estimated): November 11, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

CN (1)