Nephrotic SyndromeBiobankSNINCT04174066
From Immune System Damage to Podocyte Cell Damage: Prospective Database and Biological Collection of Patients (Children and Adults) With MGLS and HSFP
An observational study of Nephrotic Syndrome, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
Idiopathic Nephrotic Syndrome (INS) is a kidney disease characterized by massive proteinuria and hypoalbuminemia. It includes two anatomopathological entities: nephrotic syndrome with minimal glomerular lesions (SNLGM) and primary segmental and focal hyalinosis (PHF). Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- blood sample, tissue sample and excreta
- How many people
- 144 participants
- Where
- 2 sitesFrance
- Study dates
- 20 May 2020to 20 May 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patient with Idiopathic Nephrotic Syndrome
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Nice Hospital
Nice, 06000
Barbara SEITZ POLSKI, 334 92 03 55 02, seitz-polski.b@chu-nice.fr
Barbara SEITZ POLSKI
- Recruiting
APHP
Paris, 75000
Vincent Audard, (33)149814446, vincent.audard@aphp.fr
Vincent AUDARD
About this study
Official title: From Immune System Damage to Podocyte Cell Damage: Prospective Database and Biological Collection of Patients (Children and Adults) With Minimal Glomerular Injury Nephrotic Syndrome (MGLS) and Primary Segmental and Focal Hyalinosis (HSFP)
Idiopathic Nephrotic Syndrome (INS) is a kidney disease characterized by massive proteinuria and hypoalbuminemia. It includes two anatomopathological entities: nephrotic syndrome with minimal glomerular lesions (SNLGM) and primary segmental and focal hyalinosis (PHF). Renal biopsy reveals a fusion of the feet of the podocytes without inflammatory lesions or deposits of immune complexes. Clinical and experimental observations strongly suggest that the immune system and podocyte dysfunction are the two facets of the disease. There are currently no clinical or biological markers to predict the diagnosis of corticosteroid sensitivity, corticosteroid dependence, or risk of recurrence of kidney disease after kidney transplantation. To our knowledge, no prospective studies have been designed to study both immune system alterations and podocyte damage as well as genetic predisposition variants in NIS. Therefore, the use of steroids/immunosuppressive agents is purely empirical with a multitude of side effects.
The objective is to identify and test new therapeutic targets rather than conducting new trials with existing treatments, using either drug candidates or molecules selected by high throughput screening of libraries of repositioning molecules using an appropriate read-out. The biobank may also be used to analyze the effects of conventional treatments on identified new biomarkers. We expect the project to produce original and patentable results with subsequent valuation. Patentability will be anticipated before any publication on the subject. The patent and valorization cells of hospitals, INSERM and Universities will be involved in the results as soon as they are obtained.
- Conditions
- Nephrotic Syndrome
- Being tested
- blood sample, tissue sample, excreta
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
blood sample during planned in the follow-up of patients.
tissue sampleOther
tissue sample during planned in the follow-up of patients.
excretaOther
urine sample during planned in the follow-up of patients.
| Study group | Role | What they receive |
|---|---|---|
| SNLGM | 70 patients with an SNLGM Receives: Other: blood sample; Other: tissue sample; Other: excreta | |
| primary FSH | 74 with a primary FSH Receives: Other: blood sample; Other: tissue sample; Other: excreta |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of biological samples
establish in each centre a prospective collection of blood, urine and kidney biopsy samples sampled and stored in accordance with standard operating procedures, supported by a harmonized clinical and biological database
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start20 May 2020
- Primary completion20 May 2031 (estimated)
- Study completion20 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174066
- Sponsor's protocol ID
- 18-PP-16
- Acronym
- BiobankSNI
- Status last verified
- Jun 2026
- First submitted
- 19 Nov 2019
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No