SLIT ABS: Study on Patients With Autoimmune Podocytopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Serum and renal tissue analysis.
- Who it may be relevant to
- Registry conditions: Nephrotic Syndrome With Edema (Diagnosis), Minimal Change Nephrotic Syndrome, Focal Segmental Glomerulosclerosis (FSGS), Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy. Basic parameters: 0 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany, Italy, Mexico, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Validation and Implementation of Diagnostic Techniques for the Detection of Circulating Factors in Patients With Autoimmune Podocytopathy
Overview
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.
Interventions
- 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
Primary outcome measures
- Analysis of anti-nephrin antibody levels [Time frame: From enrollment through 5 years of follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Italy · 10 centers
- Ospedale Santa Maria Annunziata — Bagno a Ripoli
- Meyer Children's Hospital IRCCS — Florence
- IRCCS Azienda Ospedaliero - Universitaria — Bologna
- Azienda Ospedaliero Universitaria Careggi — Florence
- Ospedale S. Giovanni di Dio — Florence
- IRCCS Istituto Giannina Gaslini — Genova
- Azienda Ospedaliero-Universitaria di Parma — Parma
- Azienda Ospedaliero Universitaria Pisana — Pisa
- … and 2 more centers
United States · 1 center
- Mayo Clinic — Rochester
Germany · 1 center
- Ludwig-Maximilians Universitat — München
Mexico · 1 center
- Hospital General de México, Mexico City — Mexico City
Spain · 1 center
- Bellvitge University Hospital — Barcelona
Identifiers
NCT: NCT07516964 · SLIT ABS