From Immune System and Kidney Cell Damage in Nephrotic Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects blood, tissue, and excreta samples from people with a first episode of idiopathic nephrotic syndrome to explore immune and podocyte factors, plus genetic variants that might predict treatment response and disease recurrence. Participants include children aged 12 months to 18 years and adults diagnosed with nephrotic syndrome, with consent procedures adapted for age. Data and biospecimens are gathered at Nice and Paris institutions to build a prospective database and biological collection. The aim is to identify biomarkers that could guide future management beyond current empirical steroid use.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* First episode of idiopathic nephrotic syndrome in a child aged 12 months to 18 years with a weight \> 10 kg and biologically defined as proteinuria \> 0.20 g / mmol creatinuria and hypoalbuminemia \<25 g / mmol
* First episode of NIS defined in adults as albumin level \<30 g / L and a urinary protein/creatinine ratio (UPCR) ≥ 300 mg / mmol systematically associated with the performance of a renal anatomopathological examination and characterized by the absence of identifiable lesions by light microscopy (SNLGM) or the presence of HSF lesions.
* For adults: signed informed consent to participate in the study
* For children: patients will be informed and a written informed consent form will be signed by both parents of the children at inclusion
* Patients affiliated to the French health system

Exclusion Criteria:

* Patients who have previously received corticosteroids and/or immunosuppressants
* Patients with reduced CH50 and/or low C3 and/or low C4 and/or low C4 (in some cases increased sC5b9 and/or presence of a C3 nephritic Factor; an anti-C3b...)
* SNLGM resulting from a secondary process (lymphoid hematopathies or neoplasia) or occurring following the administration of a treatment known to be associated with an SNLGM (lithium, interferon, non-steroidal anti-inflammatory drugs)
* Non-primary FHH (absence of Nephrotic Syndrome, etiological assessment revealing FHH secondary to an identified cause (genetic or not), no introduction of corticosteroids or immunosuppressants as first-line treatment)
* Positive serological screening test for HIV, hepatitis B or C
* Positive immunological tests for antinuclear and anti-DNA antibodies or anti-PLA2R1 and anti-THSD7A
* Patient under guardianship or curatorship

Where it's running

• Nice Hospital
  Nice, France Recruiting
• Aphp
  Paris, France Recruiting

Study contacts

• Study coordinator: Barbara SEITZ POLSKI
• Email: seitz-polski.b@chu-nice.fr
• Phone: 33 4 92 03 55 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.