INS, B Cells and Microbiota

NCT04924712 | Recruiting

• 1 other identifier: RC21_0118
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Microbiota; B-lymphocytes; Glomerulosclerosis; T-lymphocytes

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Compare blood peripheral immune populations in patients with SNI to that of type SN patients.

  3 months

• Compare intestinal microbiota in patients with SNI to that of type SN patients.

  3 months

• Compare urine microbiota in patients with SNI to that of type SN patients.

  3 months

Study Arms (2)

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.

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.

Interventions

Measurement of blood immune populations and microbiota distribution. OTHER

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 idiopathic; Patient with nephrotic syndrome no idiopathic, IgA or GEM type or other glomerulopathy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

RECRUITING

Departemental Hospital Center

La Roche-sur-Yon, 85925, France

RECRUITING

MeSH Terms

Conditions

Nephrosis, Lipoid; Glomerulosclerosis, Focal Segmental

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Nephritis

Central Study Contacts

Christophe Masset

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 14, 2021
• Study Start: January 18, 2022
• Primary Completion (Estimated): January 18, 2027
• Study Completion (Estimated): January 18, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)