Anti-nephrin antibodies in people with idiopathic nephrotic syndrome
Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome
This project tests whether adults with idiopathic nephrotic syndrome (including MCD, FSGS, and post-transplant FSGS relapse) have circulating anti-nephrin autoantibodies compared with people with primary membranous nephropathy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mario Negri Institute for Pharmacological Research Academic / other |
| Locations | 1 site (Ranica, BG) |
| Trial ID | NCT06334692 on ClinicalTrials.gov |
What this trial studies
This is a retrospective, case-control analysis measuring circulating anti-nephrin autoantibodies by in-house ELISA and commercial ELISA kits (DBA Italy / Abbexa) using samples stored in a certified biobank. Cases are adults with biopsy-proven idiopathic minimal change disease or focal segmental glomerulosclerosis, including those with post-transplant recurrence, and controls are adults with biopsy-proven primary membranous nephropathy. Patients with possible secondary causes of nephrotic syndrome or active infections at the time of sampling are excluded. The main outcome is the presence and level of anti-nephrin antibodies in cases versus controls to explore a possible biomarker linked to disease and recurrence.
Who should consider this trial
Good fit: Adults (over 18) with biopsy-proven idiopathic MCD or FSGS (including post-transplant recurrence) or adults with biopsy-proven primary membranous nephropathy who consent to sample storage in the certified biobank are ideal candidates.
Not a fit: Patients under 18, those with a plausible secondary cause of nephrotic syndrome or active viral/bacterial infection at the time of blood collection are not expected to benefit from participation in this retrospective analysis.
Why it matters
Potential benefit: If confirmed, detecting anti-nephrin antibodies could provide a blood biomarker to help diagnose disease subtype and identify patients at higher risk of recurrence after transplant.
How similar studies have performed: Early published reports have identified anti-nephrin autoantibodies in subsets of MCD/FSGS patients, but the evidence is still emerging and requires independent validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (\>18 years) males and females * Patients with biopsy-proven idiopathic MCD or FSGS (cases) * Patients with biopsy-proven idiopathic membranous nephropathy (controls) * Patients who provided consent to store their samples in the certified CRB biobank Exclusion Criteria: * Reasonable possibility of a secondary cause of NS (for cases) or MN (for controls) at time of blood collections * Active viral or bacterial infections at time of blood collections
Where this trial is running
Ranica, BG
- Clinical Research Center for Rare Disease Aldo e Cele Daccò — Ranica, Bg, Italy (Recruiting)
Study contacts
- Study coordinator: Federica Casiraghi, PhD
- Email: federica.casiraghi@marionegri.it
- Phone: +3903545351
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.