Autoimmune podocytopathy and anti-nephrin antibodies
Validation and Implementation of Diagnostic Techniques for the Detection of Circulating Factors in Patients With Autoimmune Podocytopathy
This study tests whether children and adults with nephrotic syndrome have anti-nephrin autoantibodies and whether those antibodies relate to relapses and treatment response.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 0 Years to 99 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 14 sites (Rochester, Minnesota and 13 other locations) |
| Trial ID | NCT07516964 on ClinicalTrials.gov |
What this trial studies
This multicenter project collects clinical records and available blood and kidney biopsy samples from children and adults diagnosed with podocytopathies such as minimal change disease, FSGS, collapsing glomerulopathy, or diffuse mesangial sclerosis. Laboratory analysis will search for anti-nephrin autoantibodies in serum and renal tissue and link antibody presence to histology, treatment history, and clinical outcomes. The study includes both newly diagnosed patients and those already under follow-up at participating centers, using samples obtained during routine care with informed consent. Findings will be compared across sites to better define the prevalence and clinical significance of anti-nephrin antibodies.
Who should consider this trial
Good fit: Children and adults with a diagnosis of podocytopathy (including MCD, FSGS, collapsing glomerulopathy, or diffuse mesangial sclerosis) who have available clinical data and blood and/or renal biopsy samples and who can provide informed consent are eligible.
Not a fit: Patients who cannot provide informed consent or do not have sufficient clinical records or available biological samples are not likely to benefit from this study.
Why it matters
Potential benefit: If successful, detecting anti-nephrin antibodies could help predict relapses and guide more personalized treatment choices for patients with nephrotic syndrome.
How similar studies have performed: Preliminary research has reported anti-nephrin antibodies in some patients and linked them to disease activity, but larger multicenter confirmation and clinical correlation remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota and 13 other locations
- Mayo Clinic — Rochester, Minnesota, 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, 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)
Study contacts
- Study coordinator: Paola Romagnani, MD, PhD
- Email: paola.romagnani@meyer.it
- Phone: +39 0555662563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.