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Clinical Trial of PLA2R-IgG4 Detection Kit (Time-resolved Fluorescence Immunoassay)

NCT05861869 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2024-02-21

No results posted yet for this study

Summary

The goal of this observational clinical trial is to compare assessment reagents with clinical diagnostic criteria in patients with membranous nephropathy. The main questions it aims to answer are:

* Evaluating the sensitivity and specificity of the test reagent in the diagnosis of membranous nephropathy.
* Evaluating whether the clinical diagnostic performance of the test reagent meets the requirements for auxiliary diagnosis of membranous nephropathy.

Participants will provide approximately 4ml of blood. Researchers will compare the levels of anti-PLA2RIgG4 in patients with membranous nephropathy and patients with other renal diseases,to see if there is a significant difference.

Conditions

  • Membranous Nephropathy - PLA2R Induced
  • Kidney Diseases-except Membranous Nephropathy

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER

  • Wuxi People's Hospital

    collaborator OTHER

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Zhejiang Biostar Biotechnology Co.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2024-02-29
Completion
2024-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05861869 on ClinicalTrials.gov