An interventional study of Serum and renal tissue analysis in Nephrotic Syndrome With Edema (Diagnosis), Minimal Change Nephrotic Syndrome and Focal Segmental Glomerulosclerosis (FSGS), sponsored by Meyer Children's Hospital IRCCS. Recruiting at 14 sites in 5 countries. Open to participants aged 0 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Meyer Children's Hospital IRCCS · Not applicable, Interventional, and Basic science
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.
Exclusion Criteria:
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
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.
Time frame: From enrollment through 5 years of follow-up
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Meyer Children's Hospital IRCCS