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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Membranous Nephropathy - PLA2R Induced; Kidney Diseases-except Membranous Nephropathy

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • ZhejiangBiostar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Nephrology department visit /inpatient case

Description

Inclusion Criteria:

• 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 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.

Exclusion Criteria:

1. 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;
2. Non-serum samples, plasma samples;
3. Patients with mental or cognitive disorders;
4. No samples with definite clinical diagnosis;
5. Samples with incomplete information.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhejiang Biostar Biotechnology Co.
• Collaborators: First Affiliated Hospital of Zhejiang University; Guangdong Provincial People's Hospital; Wuxi People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: May 6, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Glomerulonephritis, Membranous
• Other Study ID Numbers: ZJBS-PLA2R IgG4-2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No