Non-invasive diagnosis for idiopathic nephrotic syndrome using blood antibodies and a routine-data score
Non-invasive Diagnosis of Idiopathic Nephrotic Syndromes : DNI-SNI
This project will test whether blood antibody tests together with a routine-data score (SNIT) can diagnose idiopathic nephrotic syndrome without a kidney biopsy in adults with a first episode who are anti-PLA2R negative.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 265 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, France) |
| Trial ID | NCT06820866 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational validation of the SNIT diagnostic score combined with routine blood antibody testing to identify the main differential diagnoses of idiopathic nephrotic syndrome. Consecutive eligible adults hospitalized for a first episode of nephrotic syndrome will have standardized clinical and laboratory data collected and the SNIT score computed automatically in the case report form but hidden from treating clinicians. Patients receive standard medical care and are followed at one month, with final diagnosis obtained from histopathology when a biopsy is performed (within four months). The protocol does not change patient management and aims to compare the non-invasive diagnosis against the reference renal biopsy result.
Who should consider this trial
Good fit: Adults hospitalized for a first episode of nephrotic syndrome (proteinuria >3 g/g and albumin <30 g/L), who are anti-PLA2R negative and for whom a diagnostic renal biopsy is planned, are the ideal candidates.
Not a fit: Patients with positive anti-PLA2R antibodies, known lupus nephropathy or IgA nephropathy before the current episode, or those who do not meet nephrotic criteria are unlikely to benefit from this diagnostic approach.
Why it matters
Potential benefit: If successful, this approach could allow many patients to be diagnosed without a renal biopsy, reducing procedure-related risks and morbidity.
How similar studies have performed: Serum anti-PLA2R antibody testing is an established non-invasive marker for membranous nephropathy, but the SNIT score was developed retrospectively and lacks prospective validation until now.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years and older * Hospitalized for a first episode of nephrotic syndrome (proteinuria greater than 3g/g and albumin level \< 30g/L) * Negative anti-PLA2r antibodies in the blood * Requirement for a renal biopsy for diagnostic purposes Exclusion Criteria: * Patients with known lupus nephropathy (prior to the current episode) * Patients with known IgA nephropathy (prior to the current episode)
Where this trial is running
Paris, France
- Service de Néphrologie et Dialyses, Hôpital Tenon — Paris, France, France (Recruiting)
Study contacts
- Principal investigator: Alexandre LAHENS, Dr — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Alexandre LAHENS, Dr
- Email: alexandre.lahens@aphp.fr
- Phone: +33 1 56 01 70 43
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.