Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
NCT ID:
NCT04174066
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Study:
NCT04174066
Study Brief:
Protocol Section:
NCT04174066