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NCT06456801 Clinical Trial

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

Nephropathy Clinical Trial

Official title:
Clinical Trial of Anti-PLA2R-IgG Detection Kit (Time-resolved Fluorescence Immunoassay)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06456801
Other study ID # zjbs-pla2r-2012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date October 1, 2021

Study information
Verified date June 2024
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.

Description:

Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.

Recruitment information / eligibility
Status Completed
Enrollment 219
Est. completion date October 1, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Clear background information and traceable sources of samples from kidney disease patients (number, age, gender, and clinical diagnostic information). Exclusion Criteria: Exclude serum samples that meet one of the following conditions: ? Samples with insufficient sample size, ? Samples with incomplete sample information.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China The First Affiliated hospital Zhejiang University school of medicine Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Calculate the correlation between the test reagents and comparison reagents Calculate the correlation between the test reagents and comparison reagents 1 year.
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