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Establishment and Clinical Application of the Detection Method for Serum Biomarker anti-PLA2R-IgG4 in Idiopathic Membranous Nephropathy

Establishment and Clinical Application of the Detection Method for Serum Biomarker anti-PLA2R-IgG4 in Idiopathic Membranous Nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100307
Enrollment
Unknown
Registered
2025-04-07
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-04-14

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-IgG4

Sponsors

Suzhou Ninth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: This study is a non-randomized controlled clinical trial, and it is estimated that more than 50 patients with IMN nephropathy, more than 100 patients with other immune diseases, and more than 100 normal people will be included in this study according to the scale of our hospital and the number of patients admitted to the Department of Nephrology in previous years. 1. Age: > = 18 years old, < 70 years old, gender is not limited; 2. Newly diagnosed patients and successfully obtained renal pathological diagnosis results; 3. Not receiving immunosuppressant and/or glucocorticoid therapy; 4. Willing and able to understand this study: Able to comply with all elements of the study protocol and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combined with serious infections, cardiovascular and cerebrovascular diseases and other major comorbidities; 2. Patients with end-stage renal disease (eGFR<15ml/min/1.73m^2). 3. Myocardial infarction, unstable angina, stroke or hospitalization due to heart failure 3 months before the study; 4. Those who participated in other clinical trials within 3 months before the study and received experimental drugs; 5. Those who are pregnant or breastfeeding; 6. Patients with mental abnormalities, intellectual disabilities and other patients who cannot cooperate with the study; 7. Presence of a condition as assessed by the investigator that would interfere with the interpretation of study results, or compromise compliance with study procedures or affect the safety of the subject.

Design outcomes

Primary

MeasureTime frame
anti-PLA2R-IgG4;anti-PLA2R-IgG;24-hour urinary protein quantification;Serum Albumin;Serum Creatinine;Renal Pathology;

Secondary

MeasureTime frame
Urinary Albumin-to-Creatinine Ratio (UACR);Triglycerides and Total Cholesterol;Total Cholesterol;

Countries

Chian

Contacts

Public ContactXu Yan

Suzhou Ninth People's Hospital

xyfrancecrazy@163.com+86 134 0527 1358

Outcome results

None listed

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