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Impact of Anti-rituximab Antibodies and Rituximab Blood Concentration on Prognosis in Patients with Membranous Nephropathy: A Prospective Cohort Study

Impact of Anti-rituximab Antibodies and Rituximab Blood Concentration on Prognosis in Patients with Membranous Nephropathy: A Prospective Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118647
Enrollment
Unknown
Registered
2026-02-09
Start date
2026-02-10
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Membranous nephropathy

Interventions

Observation group:None

Sponsors

The Second People’s Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects voluntarily participate in the study and sign the informed consent form; 2. Aged >=18 years, regardless of gender; 3. Membranous nephropathy (MN) confirmed by renal biopsy; 4. Estimated glomerular filtration rate (eGFR) > 40 ml/min; 5. Received rituximab treatment; 6. Expected survival time >= 12 months;

Exclusion criteria

Exclusion criteria: 1. Secondary nephrotic syndrome; 2. Treatment with immunosuppressants (e.g., tacrolimus, cyclosporine, cyclophosphamide, etc.); 3. Complicated with infectious diseases such as hepatitis B, hepatitis C, and HIV; 4. Hypersensitivity to rituximab or murine proteins; 5. Complicated with severe active infection; 6. Patients with severe impairment of immune response (e.g., hypogammaglobulinemia, significant reduction in CD4 or CD8 cell counts); 7. Complicated with severe heart failure (NYHA Class ?); 8. Complicated with malignant tumors (e.g., prostate cancer, breast cancer, renal cell carcinoma, etc.); 9. Pregnancy, lactation, or use of unreliable contraceptive methods.

Design outcomes

Primary

MeasureTime frame
Complete or partial proteinuria remission rate at 12 months;

Secondary

MeasureTime frame
Complete or partial proteinuria remission rate at 6 months;Treatment non-response rate at 6 and 12 months;Either a 50% increase in eGFR from baseline or progression to ESRD;Complete remission rate at June and December;Immunological response index, protein and renal function index;

Countries

China

Contacts

Public ContactYu Yi

The Second People’s Hospital of Shenzhen

774358007@qq.com+86 178 5313 7776

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026