Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-30 @ 12:34 AM
Study NCT ID:
NCT05861869
Status:
UNKNOWN
Last Update Posted:
2024-02-21
First Post:
2023-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of PLA2R-IgG4 Detection Kit (Time-resolved Fluorescence Immunoassay)
Sponsor:
Zhejiang Biostar Biotechnology Co.
Organization:
Study Overview
Official Title:
Clinical Trial of PLA2R-IgG4 Detection Kit (Time-resolved Fluorescence Immunoassay)
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: