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INS, B Cells and Microbiota

Controlled Multicenter Epidemiological Study of Peripheral Leukocyte Populations and Microbiota in Patients With Idiopathic Nephrotic Syndrome (INS)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04924712
Enrollment
30
Registered
2021-06-14
Start date
2022-01-18
Completion date
2027-01-18
Last updated
2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-lymphocytes, Glomerulosclerosis, Microbiota, T-lymphocytes

Keywords

Idiopathic Nephrotic Syndrome, Focal Segmental Glomerulosclerosis, Microbiota, B Lymphocytes, Regulatory T cells

Brief summary

Idiopathic nephrotic syndrome (NIS) is a clinical entity defined by the association of selective albuminuria, hypoalbuminemia, and nonspecific glomerular lesions (lesions minimal glomerular (LGM) or segmental and focal hyalinosis (HSF). The complication of this kidney disease is the progression towards chronic renal failure and in case of kidney transplantation, its immediate recurrence on the graft . The origin of this syndrome is unknown but a number of clinical observations tend to show an involvement of immune system. A link has been highlighted between atopy, diet and nephrotic flare-ups. The speed of recurrence of this initial disease on the graft and the observation of remissions obtained after treatment by plasma exchange or immunoadsorptions support the presence of a pathogenic plasma factor. Anti-CD20 treatments depleting B lymphocytes has made it possible to favorably treat a number of patients. Dysfunction of regulatory T cells has also been shown in SNI patients. This modification seems linked to allergies and could be due to an aberrant microbiota. The hypothesis of causality between dysbiosis, alteration lymphocyte and triggering of an SNI was mentioned recently. Two studies have shown intestinal dysbiosis in pediatric SNI/LGM, with reduction of T circulating regulators

Interventions

OTHERMeasurement of blood immune populations and microbiota distribution.

Measurement of peripheral cell populations by spectral cytometry and in parallel, sequencing of intestinal and urinary bacterial 16S RNA of each patient.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

: * Patient treated in participating centers * In nephrotic attack, defined biologically by: Proteinuria \> 3g 24h or A proteinuria/creatinuria ratio \> 3 or Defined at the discretion of the clinician Non inclusion Criteria : * Patient with a history of NIS flare-ups resistant to corticosteroid therapy * Patient treated with immunosuppressant * Patient treated with corticosteroids \> 10 mg/d * Weight \<50 kg * Pregnant woman * Patient under guardianship / curatorship

Design outcomes

Primary

MeasureTime frameDescription
Sequencing and analysis of blood peripheral immune populations and intestinal and urinary microbiota3 monthsFor the analysis of peripheral populations, blood cells will be collected by density gradient (Ficoll) and frozen in 20% DMSO. They will then be marked and identified by flow cytometry.
Sequencing and analysis of intestinal microbiota3 monthsThe microbiota will be analyzed using DNA extracted from fecal samples.
Sequencing and analysis of urinary microbiota3 monthsThe microbiota will be analyzed using DNA extracted from urine samples.

Secondary

MeasureTime frameDescription
Compare blood peripheral immune populations in patients with SNI to that of type SN patients.3 monthsWe will collect clinical and biological variables from each patient with a syndrome nephrotic type GEM or IgA as well as the results of the analysis of populations peripheral immune systems.
Compare intestinal microbiota in patients with SNI to that of type SN patients.3 monthsWe will collect clinical and biological variables from each patient with a syndrome nephrotic type GEM or IgA as well as the results of the analysis of the microbiota
Compare urine microbiota in patients with SNI to that of type SN patients.3 monthsWe will collect clinical and biological variables from each patient with a syndrome nephrotic type GEM or IgA as well as the results of the analysis of the microbiota

Countries

France

Contacts

CONTACTChristophe Masset
christophe.masset@chu-nantes.fr+33 2 76 64 39 61

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026