SLIT ABS: Study on Patients With Autoimmune Podocytopathy

April 1, 2026 updated by: Meyer Children's Hospital IRCCS

Validation and Implementation of Diagnostic Techniques for the Detection of Circulating Factors in Patients With Autoimmune Podocytopathy

Nephrotic syndrome is a kidney condition that mainly affects children and is characterized by high levels of protein in the urine, low levels of protein in the blood, and swelling. While many children respond well to steroid treatment, a large proportion experience relapses or become dependent on therapy. In some cases, the disease does not respond to standard treatments and may progress to chronic kidney disease.

Recent research suggests that, in addition to genetic factors, immune system mechanisms may play a key role in the development and progression of nephrotic syndrome. In particular, some patients produce autoantibodies against nephrin, an essential protein of the kidney filtration barrier. These autoantibodies may be associated with disease activity and treatment response.

The aim of this study is to investigate the presence of anti-nephrin autoantibodies in children with nephrotic syndrome and to better understand their role in disease mechanisms and clinical outcomes.The study will also explore the presence of other autoantibodies targeting components of the glomerular filtration barrier. The study will use advanced laboratory techniques, including blood tests and detailed analysis of kidney biopsy samples, to identify these antibodies and their relationship with kidney structure and function.

By integrating laboratory findings with clinical data, this study aims to improve the understanding of nephrotic syndrome and support the development of more personalized diagnostic and therapeutic strategies, with the goal of improving patient outcomes and reducing unnecessary or ineffective treatments.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • München, Germany
        • Not yet recruiting
        • Ludwig-Maximilians Universitat
  • Italy
      • Bologna, Italy
        • Not yet recruiting
        • IRCCS Azienda Ospedaliero - Universitaria
      • Florence, Italy
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria Careggi
      • Florence, Italy
        • Not yet recruiting
        • Ospedale S. Giovanni di Dio
      • Genova, Italy
        • Not yet recruiting
        • IRCCS Istituto Giannina Gaslini
      • Parma, Italy
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria di Parma
      • Pisa, Italy
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria Pisana
      • Prato, Italy
        • Not yet recruiting
        • Ospedale Santo Stefano
      • Reggio Emilia, Italy
        • Not yet recruiting
        • Azienda USL - IRCCS
    • FIRENZE
    • Firenze
      • Bagno a Ripoli, Firenze, Italy
        • Not yet recruiting
        • Ospedale Santa Maria Annunziata
  • Mexico
      • Mexico City, Mexico
        • Not yet recruiting
        • Hospital General de México, Mexico City
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Bellvitge University Hospital
  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Not yet recruiting
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pediatric and adult patients with a diagnosis of podocytopathy
  • Patients with nephrotic syndrome and/or histological diagnosis of minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), collapsing glomerulopathy (CG), or diffuse mesangial sclerosis (DMS)
  • Both newly diagnosed (incident) patients and patients already under follow-up at participating centers
  • Availability of clinical data from medical records (including paper and/or electronic records, laboratory reports, and discharge summaries)
  • Availability of biological samples (e.g., blood and/or renal biopsy), if collected as part of routine clinical care
  • Signed informed consent by the patient or legal guardian (and assent when applicable)

Exclusion Criteria:

  • Refusal or inability of the patient, parents, or legal guardian to provide informed consent
  • Lack of sufficient clinical data or unavailable biological samples required for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pediatric and adult patients with podocytopathies
Participants are not assigned to therapeutic interventions. Serum and renal biopsy samples obtained during routine clinical care are collected and analyzed for research purposes, including ELISA testing for anti-nephrin antibodies, others anti-slit antibodies and advanced microscopy evaluation.
Other: Serum and renal tissue analysis
Analysis of serum and renal biopsy material collected as part of routine clinical care. Laboratory procedures include ELISA assays for the detection of anti-nephrin and/or others anti-slit antibodies and advanced imaging techniques, such as high-resolution confocal microscopy and STED microscopy, performed for research purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of anti-nephrin antibody levels
Time Frame: From enrollment through 5 years of follow-up
Detection of circulating anti-nephrin antibodies in serum by ELISA and localization of antibody binding in renal biopsy tissue using high-resolution confocal and STED microscopy.
From enrollment through 5 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meyer Children's Hospital IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2025

Primary Completion (Estimated)

October 1, 2034

Study Completion (Estimated)

October 1, 2036

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLIT ABS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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