INS, B Cells and Microbiota

Recruiting now

Conditions studied: Microbiota, B-lymphocytes, Glomerulosclerosis, T-lymphocytes

In brief

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

Key facts

Study ID

NCT04924712

Run by

Nantes University Hospital

People needed

30

Starts

2022-01-18

Expected to finish

2027-01-18

Last updated by the study team

2026-03-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Nantes University Hospital — Nantes, Loire-Atlantique, France (enrolling)
• Departemental Hospital Center — La Roche-sur-Yon, France (enrolling)

Full record on ClinicalTrials.gov

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