INS, B Cells and Microbiota

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

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

Study Overview

• Status: Recruiting
• Conditions: Microbiota; Glomerulosclerosis; B-lymphocytes; T-lymphocytes
• Intervention / Treatment: Other: Measurement of blood immune populations and microbiota distribution.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Christophe Masset; Phone Number: +33 2 76 64 39 61; Email: christophe.masset@chu-nantes.fr

Study Locations

• France
  • La Roche-sur-Yon, France, 85925
    • Recruiting
    • Departemental Hospital Center
    • Contact: Awena LEFUR; Phone Number: 0251446161; Email: awena.lefur@ght85.fr
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Recruiting
      • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with idiopathic nephrotic syndrome (LGM or HSF type) will be considered in the main objective, patients with IgA or GEM type nephrotic syndrome or other glomerulopathy will be integrated into the control group for the secondary objectivets

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with nephrotic syndrome idiopathic; nephrotic INS patients in primary visit: harvesting of 27.5 ml supplementary blood, 40 mlurine and feces at inclusion visit and at 3 months. No intervention, no treatment administration other than usual/routine INS treatment.	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.
Patient with nephrotic syndrome no idiopathic, IgA or GEM type or other glomerulopathy; At least 10 NS no idipathic patients: harvesting of 27.5 ml supplementary blood, 40 ml urine and feces at inclusion visit and at 3 months. No intervention, no treatment administration other than usual/routine care treatment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sequencing and analysis of blood peripheral immune populations and intestinal and urinary microbiota	For 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.	3 months
Sequencing and analysis of intestinal microbiota	The microbiota will be analyzed using DNA extracted from fecal samples.	3 months
Sequencing and analysis of urinary microbiota	The microbiota will be analyzed using DNA extracted from urine samples.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare blood peripheral immune populations in patients with SNI to that of type SN patients.	We 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.	3 months
Compare intestinal microbiota in patients with SNI to that of type SN patients.	We 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	3 months
Compare urine microbiota in patients with SNI to that of type SN patients.	We 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	3 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Estimated): January 18, 2027
• Study Completion (Estimated): January 18, 2027

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Microbiota; Focal Segmental Glomerulosclerosis; Regulatory T cells; Idiopathic Nephrotic Syndrome; B Lymphocytes
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Glomerulonephritis; Nephritis; Nephrosis; Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid
• Other Study ID Numbers: RC21_0118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No