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A Multi-center Study on Autoantibodies in Membranous Nephropathy Using Magnetic Particle Chemiluminescence

A Multi-center Study on Autoantibodies in Membranous Nephropathy Using Magnetic Particle Chemiluminescence

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113573
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

membranous nephropathy

Interventions

Index test:PLA2R antibody, THSD7A antibody, and C1q antibody are detected in serum using magnetic particle chemiluminescence immunoassay.

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Gender: No restriction, both male and female patients are eligible for enrollment. It is recommended that the proportion of females be no less than 30% (the male-to-female ratio in membranous nephropathy is approximately 2:1). Postmenopausal women should be specifically indicated (due to the influence of hormones on immune status). 2. Age: It is recommended to include patients aged 18–75 years (primarily adult patients to avoid the influence of physiological differences in children or the elderly on antibody levels). 3. Healthy Control Group: Age- and gender-matched completely healthy individuals from a physical examination population, with no history of kidney disease (glomerular filtration rate >=90 mL/min/1.73m², negative for urinary protein) or family history of autoimmune diseases. 4. Membranous Nephropathy Group: Patients diagnosed with membranous nephropathy, with idiopathic membranous nephropathy classified into stages I–IV according to the Ehrenreich-Churg staging system. Patients pathologically confirmed to have atypical membranous nephropathy should be actively investigated for secondary causes. Those who are informed about the study and have signed the consent form are included. The presence of proteinuria is required.

Exclusion criteria

Exclusion criteria: 1. Patients with diabetes, obesity, malignant tumors, acute kidney disease, severe comorbidities (such as severe infections, cardiovascular, hepatic, hematopoietic, or neuropsychiatric system diseases), pregnant or lactating women, and patients with mental disorders or cognitive dysfunction. 2. Use of rituximab or other B-cell-depleting agents that may affect antibody testing within the past 3 months. 3. Use of high-dose corticosteroid therapy. 4. Vaccination within the past 3 months.

Design outcomes

Primary

MeasureTime frame
THSD7A antibody;PLA2R antibody;Negative Predictive Value;Sensitivity;Area Under the ROC Curve;Specificity;Youden's Index;Accuracy;Prevalence;Positive Predictive Value;

Secondary

MeasureTime frame
C1q antibody;

Countries

China

Contacts

Public ContactGuan Ming

Huashan Hospital, Fudan University

guanming88@yahoo.com+86 21 5288 8048

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026