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

NCT05861869 | Unknown

• 1 other identifier: ZJBS-PLA2R IgG4-2201
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Content of anti-PLA2r IgG4

  Evaluating the sensitivity and specificity of the test reagent in the diagnosis of membranous nephropathy

  through study completion, an average of 1 year

Study Arms (2)

PLA2R-induced membranous nephropathy group

1. Pathological examination showed that patients with membranous nephropathy were positive for PLA2R by immunohistochemistry, and the symptoms were not completely relieved; (24 h urine protein quantification\<0.3g or urine protein /creatinine (uPCR)\<300mg /g is regarded as complete remission) 2. In patients with nephrotic syndrome (serum albumin ≤ 30.0g /L, clinical manifestations show moderate to large amount of proteinuria (urine protein\>3.5g /L or urine protein /creatinine ratio ≥ 3500mg /g), and their serum anti PLA2R antibody detection shows positive.

Secondary membranous nephropathy group

1. Patients in nephrology department who have ruled out primary membranous nephropathy. 2. the patient has the remaining serum samples of normal test, and the serum volume of the sample is not less than 1ml.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nephrology department visit /inpatient case

You may qualify if:

• PLA2R-induced membranous nephropathy group
• Pathological examination showed that patients with membranous nephropathy were positive for PLA2R by immunohistochemistry, and the symptoms were not completely relieved; (24 h urine protein quantification\<0.3g or urine protein /creatinine (uPCR)\<300mg /g is regarded as complete remission)
• In patients with nephrotic syndrome (serum albumin ≤ 30.0g /L, clinical manifestations show moderate to large amount of proteinuria (urine protein\>3.5g /L or urine protein /creatinine ratio ≥ 3500mg /g), and their serum anti PLA2R antibody detection shows positive.
• Secondary membranous nephropathy group Patients in nephrology department who have ruled out primary membranous nephropathy.
• the patient has the remaining serum samples of normal test, and the serum volume of the sample is not less than 1ml.

You may not qualify if:

• The amount of centrifuged serum sample after blood collection is less than 1ml or the amount of residual serum in normal test is less than 1ml;
• Non-serum samples, plasma samples;
• Patients with mental or cognitive disorders;
• No samples with definite clinical diagnosis;
• Samples with incomplete information.

Sponsors & Collaborators

• Zhejiang Biostar Biotechnology Co.: lead
• First Affiliated Hospital of Zhejiang University: collaborator
• Wuxi People's Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator

Study Sites (1)

ZhejiangBiostar

Hangzhou, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 17, 2023
• Study Start: May 4, 2023
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)