SLIT ABS: Study on Patients With Autoimmune Podocytopathy

NCT07516964 | Recruiting

• 1 other identifier: SLIT ABS
• Study Type: interventional
• Target: 50
• Locations: 5 countries
• Sites: 14

Brief Summary

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.

Conditions

Nephrotic Syndrome With Edema (Diagnosis); Minimal Change Nephrotic Syndrome; Focal Segmental Glomerulosclerosis (FSGS); Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy

Outcome Measures

Primary Outcomes (1)

• Analysis of anti-nephrin antibody levels

  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

Study Arms (1)

Pediatric and adult patients with podocytopathies

EXPERIMENTAL

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

Interventions

Serum and renal tissue analysis OTHER

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

Pediatric and adult patients with podocytopathies

Eligibility Criteria

• Age: 0 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (14)

Mayo Clinic

Rochester, Minnesota, 55902, United States

NOT YET RECRUITING

Ludwig-Maximilians Universitat

München, Germany

NOT YET RECRUITING

Ospedale Santa Maria Annunziata

Bagno a Ripoli, Firenze, Italy

NOT YET RECRUITING

Meyer Children's Hospital IRCCS

Florence, FIRENZE, 50139, Italy

RECRUITING

IRCCS Azienda Ospedaliero - Universitaria

Bologna, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

NOT YET RECRUITING

Ospedale S. Giovanni di Dio

Florence, Italy

NOT YET RECRUITING

IRCCS Istituto Giannina Gaslini

Genova, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

NOT YET RECRUITING

Ospedale Santo Stefano

Prato, Italy

NOT YET RECRUITING

Azienda USL - IRCCS

Reggio Emilia, Italy

NOT YET RECRUITING

Hospital General de México, Mexico City

Mexico City, Mexico

NOT YET RECRUITING

Bellvitge University Hospital

Barcelona, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Disease; Nephrosis, Lipoid; Glomerulosclerosis, Focal Segmental

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Nephritis

Central Study Contacts

Paola Romagnani, MD, PhD

CONTACT

+39 0555662563; paola.romagnani@meyer.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are not assigned to therapeutic interventions. Biological samples and clinical data are collected within routine care.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: June 10, 2025
• Primary Completion (Estimated): October 1, 2034
• Study Completion (Estimated): October 1, 2036
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1); ES (1); DE (1); IT (10); ME (1)