Autoimmune podocytopathy and anti-nephrin antibodies
Official title: Validation and Implementation of Diagnostic Techniques for the Detection of Circulating Factors in Patients With Autoimmune Podocytopathy
Run by Meyer Children's Hospital IRCCS · NCT07516964 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 0 Years to 99 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 14 sites (Rochester, Minnesota and 13 other locations) |
| Status | Recruiting |
| Started | June 10, 2025 |
| Main results expected | October 2034 |
| Study ends | October 2036 |
| Registry record updated | April 8, 2026 |
| Trial ID | NCT07516964 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Meyer Children's Hospital IRCCS
Florence, Firenze, Italy Recruiting -
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 -
IRCCS Azienda Ospedaliero - Universitaria
Bologna, Italy Not yet recruiting -
Azienda Ospedaliero Universitaria Careggi
Florence, Italy Not yet recruiting
Show 8 more locations
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Exploring experiences of patients and parents dealing with swelling from Nephrotic Syndrome
This study talks to patients and parents about their experiences with swelling from Nephrotic Syndrome to help create better ways to measure how new treatments work.
-
Everest001: a medicine for certain kidney diseases to see if it helps adults
This study tests EVER001 in adults with FSGS, MCD, or IgA nephropathy to see if it can help reduce protein in the urine and improve kidney function.
-
BAT4406F injection for people with Minimal Change Disease or Focal Segmental Glomerulosclerosis
BAT4406F injections will be tested to see if they help people with Minimal Change Disease or Focal Segmental Glomerulosclerosis who recently reached remission after corticosteroid treatment.
-
Using Raman Spectroscopy to Diagnose Kidney Diseases
This study is testing a new way to diagnose kidney diseases by analyzing urine and blood samples from patients with specific kidney conditions to see if it can help identify the diseases more accurately.
-
NEPTUNE Match: Personalized matching of patients to kidney treatment options
This project will try a system that matches people in the NEPTUNE cohort who have nephrotic syndromes or related kidney diseases with suitable clinical trials and shares those matches with patients and their doctors.
-
Treatment with AP1189 for patients with severe proteinuria due to idiopathic membranous nephropathy
This study is testing if a new drug called AP1189 can help people with severe proteinuria caused by idiopathic membranous nephropathy feel better when added to their current treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.