Minimal Change Disease Clinical Trials

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

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 99
Healthy Volunteers: f
View:

• 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)

Locations
United States
Minnesota
Mayo Clinic
NOT_YET_RECRUITING
Rochester
Other Locations
Germany
Ludwig-Maximilians Universitat
NOT_YET_RECRUITING
München
Italy
Ospedale Santa Maria Annunziata
NOT_YET_RECRUITING
Bagno A Ripoli
IRCCS Azienda Ospedaliero - Universitaria
NOT_YET_RECRUITING
Bologna
Azienda Ospedaliero Universitaria Careggi
NOT_YET_RECRUITING
Florence
Meyer Children's Hospital IRCCS
RECRUITING
Florence
Ospedale S. Giovanni di Dio
NOT_YET_RECRUITING
Florence
IRCCS Istituto Giannina Gaslini
NOT_YET_RECRUITING
Genova
Azienda Ospedaliero-Universitaria di Parma
NOT_YET_RECRUITING
Parma
Azienda Ospedaliero Universitaria Pisana
NOT_YET_RECRUITING
Pisa
Ospedale Santo Stefano
NOT_YET_RECRUITING
Prato
Azienda USL - IRCCS
NOT_YET_RECRUITING
Reggio Emilia
Mexico
Hospital General de México, Mexico City
NOT_YET_RECRUITING
Mexico City
Spain
Bellvitge University Hospital
NOT_YET_RECRUITING
Barcelona
Contact Information
Primary
Paola Romagnani, MD, PhD
paola.romagnani@meyer.it
+39 0555662563
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2036-10
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Leads: Meyer Children's Hospital IRCCS

This content was sourced from clinicaltrials.gov