Actively Recruiting

Age: 18Years +
All Genders
ID06334692

Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome

Led by Mario Negri Institute for Pharmacological Research · Updated on 2025-09-04

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying idiopathic nephrotic syndrome (INS), which includes minimal change disease (MCD) and focal segmental glomerulosclerosis (FSGS), and comparing it to primary membranous nephropathy (MN). The goal is to evaluate the levels of circulating anti-nephrin autoantibodies, which may play a role in INS and post-transplant FSGS relapse. INS is a serious kidney condition with unclear causes and limited treatment options, especially when it recurs after transplantation. The study involves testing stored blood samples from patients with biopsy-confirmed idiopathic MCD or FSGS and those with membranous nephropathy. These samples will be analyzed using specialized ELISA tests to measure anti-nephrin autoantibody levels. The tests use recombinant nephrin protein and antibodies to detect these autoantibodies in the blood, comparing patients with INS to those with MN. Participants have previously provided consent for their samples to be stored in a certified biobank. Researchers will analyze these samples retrospectively over about one year to measure antibody levels. The study focuses on laboratory analysis without direct patient involvement, aiming to better understand the potential role of anti-nephrin autoantibodies in nephrotic syndrome and its recurrence after kidney transplant.

CONDITIONS

Brief Title

Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years of age
  • Patients with biopsy-confirmed idiopathic minimal change disease or focal segmental glomerulosclerosis
  • Patients with biopsy-confirmed idiopathic membranous nephropathy
  • Patients who have consented to store their samples in the certified CRB biobank
Not Eligible

You will not qualify if you...

  • Possible secondary causes of nephrotic syndrome or membranous nephropathy at the time of blood collection
  • Active viral or bacterial infections at the time of blood collection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 year to perform analysis

Participants provide serum samples which will be tested for levels of anti-nephrin autoantibodies using ELISA techniques.

1 visit for blood sample collection

Long-term Monitoring

Duration - Up to 1 year

Participants' serum samples are observed retrospectively to assess anti-nephrin autoantibody levels in patients with nephrotic syndrome compared to controls.

No additional visits required

Trial Site Locations

Total: 1 location

1

Clinical Research Center for Rare Disease Aldo e Cele Daccò

Ranica, BG, Italy, 24020

Actively Recruiting

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Research Team

F

Federica Casiraghi, PhD

N

Norberto Perico, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Discovery of Autoantibodies Targeting Nephrin in Minimal Change Disease Supports a Novel Autoimmune Etiology.

Andrew J B Watts, Keith H Keller, Gabriel Lerner...

https://pubmed.ncbi.nlm.nih.gov/34732507

Immunophenotypic Alterations in Adult Patients with Steroid-Dependent and Frequently Relapsing Nephrotic Syndrome.

Federica Casiraghi, Marta Todeschini, Manuel Alfredo Podestà...

https://pubmed.ncbi.nlm.nih.gov/37175393

Current understanding of the molecular mechanisms of circulating permeability factor in focal segmental glomerulosclerosis.

Giuseppe Salfi, Federica Casiraghi, Giuseppe Remuzzi

https://pubmed.ncbi.nlm.nih.gov/37795085

A multi-institutional study found a possible role of anti-nephrin antibodies in post-transplant focal segmental glomerulosclerosis recurrence.

Yoko Shirai, Kenichiro Miura, Kiyonobu Ishizuka...

https://pubmed.ncbi.nlm.nih.gov/38110152

Anti-nephrin antibodies are not enriched in patients with primary and post-transplant recurrent podocytopathies.

Francesco Pecoraro, Luca Perico, Federica Casiraghi...

https://pubmed.ncbi.nlm.nih.gov/42048157