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INS, B Cells and Microbiota

NCT04924712 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-03-03

No results posted yet for this study

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

Conditions

  • Microbiota
  • B-lymphocytes
  • Glomerulosclerosis
  • T-lymphocytes

Interventions

OTHER

Measurement 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 & Collaborators

  • Nantes University Hospital

    lead OTHER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-18
Primary Completion
2027-01-18
Completion
2027-01-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04924712 on ClinicalTrials.gov