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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paola Romagnani, MD, PhD | Contact | +39 0555662563 | paola.romagnani@meyer.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Not yet recruiting | Rochester | Minnesota | 55902 | United States | |
| Ludwig-Maximilians Universitat |
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Participants are not assigned to therapeutic interventions. Biological samples and clinical data are collected within routine care.
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|
| Not yet recruiting |
| München |
| Germany |
| Ospedale Santa Maria Annunziata | Not yet recruiting | Bagno a Ripoli | Firenze | Italy |
| Meyer Children's Hospital IRCCS | Recruiting | Florence | FIRENZE | 50139 | Italy |
|
| IRCCS Azienda Ospedaliero - Universitaria | Not yet recruiting | Bologna | Italy |
| Azienda Ospedaliero Universitaria Careggi | Not yet recruiting | Florence | Italy |
| Ospedale S. Giovanni di Dio | Not yet recruiting | Florence | Italy |
| IRCCS Istituto Giannina Gaslini | Not yet recruiting | Genova | Italy |
| Azienda Ospedaliero-Universitaria di Parma | Not yet recruiting | Parma | Italy |
| Azienda Ospedaliero Universitaria Pisana | Not yet recruiting | Pisa | Italy |
| Ospedale Santo Stefano | Not yet recruiting | Prato | Italy |
| Azienda USL - IRCCS | Not yet recruiting | Reggio Emilia | Italy |
| Hospital General de México, Mexico City | Not yet recruiting | Mexico City | Mexico |
| Bellvitge University Hospital | Not yet recruiting | Barcelona | Spain |
| ID | Term |
|---|---|
| D004194 | Disease |
| D009402 | Nephrosis, Lipoid |
| D005923 | Glomerulosclerosis, Focal Segmental |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
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