Observing the effects of rituximab in treating primary membranous nephropathy

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

This study is testing whether adding hormones to rituximab can help people with primary membranous nephropathy feel better compared to using rituximab alone.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University (other)
• Drugs / interventions: rituximab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06893328 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the efficacy and safety of rituximab combined with hormones compared to rituximab alone in patients with primary membranous nephropathy. It includes a real-world component to assess outcomes in a broader population, particularly those who do not meet traditional trial criteria. The study will also explore various biological changes during treatment, including genomic, transcriptomic, proteomic, metabolomic, and microbiomic alterations. Primary outcomes will focus on the complete response rate at 12 months, while secondary outcomes will track response rates and renal function over time.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 diagnosed with primary membranous nephropathy who have not responded adequately to prior treatments.

Not a fit: Patients with secondary membranous nephropathy or active infections will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new insights into effective treatment strategies for primary membranous nephropathy.

How similar studies have performed: While this approach includes real-world observations, similar studies have shown promise in evaluating treatment efficacy in nephrology.

Eligibility criteria

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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Where this trial is running

Guangzhou, Guangdong

• Wei Chen — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Wei Chen

Conditions: Primary Membranous Nephropathy, Real-world Study