Actively Recruiting

Age: 12Years +
All Genders
NCT04924712

INS, B Cells and Microbiota

Led by Nantes University Hospital · Updated on 2026-03-03

30

Participants Needed

2

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

INS, B Cells and Microbiota

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient treated in participating centers
  • Currently experiencing a nephrotic syndrome attack defined by proteinuria > 3g/24h, or a proteinuria/creatinuria ratio > 3, or as determined by the clinician
Not Eligible

You will not qualify if you...

  • History of nephrotic syndrome flare-ups resistant to corticosteroid therapy
  • Treatment with immunosuppressants
  • Treatment with corticosteroids > 10 mg per day
  • Weight less than 50 kg
  • Pregnant woman
  • Patient under guardianship or curatorship

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Nantes University Hospital

Nantes, Loire-Atlantique, France, 44093

Actively Recruiting

2

Departemental Hospital Center

La Roche-sur-Yon, France, 85925

Actively Recruiting

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Research Team

C

Christophe Masset

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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INS, B Cells and Microbiota | DecenTrialz