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Recruiting Observational

Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome

NCT06334692 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-03-19
Last updated
2025-09-04

Condition(s) studied

Nephrotic Syndrome

Investigational drug(s) / intervention(s)

In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa).

In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa).: "Nunc MaxiSorp" ELISA plates will be coated with recombinant extracellular domain of human nephrin. Patient serum samples will be added in appropriate dilution. Plates will be then incubated with biotin-conjugated anti human IgG antibody followed by incubation with horseradish peroxidase (HRP)-avidin conjugate. Then tetramethylbenzidine substrate will be added, and absorbance read at 450 nm.

Study summary

This retrospective study is aimed at evaluating the levels of circulating anti-nephrin autoantibodies in patients with INS, including those with MCD/FSGS and in patients who have experienced relapse of FSGS post-transplant, compared to those of a control group of patients with nephrotic syndrome due to primary membranous nephropathy (MN).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult (\>18 years) males and females * Patients with biopsy-proven idiopathic MCD or FSGS (cases) * Patients with biopsy-proven idiopathic membranous nephropathy (controls) * Patients who provided consent to store their samples in the certified CRB biobank Exclusion Criteria: * Reasonable possibility of a secondary cause of NS (for cases) or MN (for controls) at time of blood collections * Active viral or bacterial infections at time of blood collections

Primary outcome measure(s)

  • Levels of circulating anti-nephrin autoantibodies — At 1 year. Given the retrospective nature of the study, the indicated time frame refers to the time required to perform the analysis, i.e to assess levels of anti-nephrin antibodies in patients with NS compared to controls.
    Serum samples will be tested for the levels of anti-nephrin autoantibodies by in-house ELISA and results confirmed by commercial ELISA kits.

Trial sites (1)

FacilityCityRegionStatus
Clinical Research Center for Rare Disease Aldo e Cele Daccò Ranica BG Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06334692 on ClinicalTrials.gov ↗ ← All trials in Italy