INS, B Cells and Microbiota

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: T-lymphocytes; B-lymphocytes; Glomerulosclerosis; Microbiota

Treatments: Other: Measurement of blood immune populations and microbiota distribution.

Study type: Observational

Funder types: Other

Identifiers

NCT04924712

RC21_0118

Details and patient eligibility

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

Enrollment: 30 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

30 participants in 2 patient groups

Patient with nephrotic syndrome idiopathic

Description:

20 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.

Treatment:

Other: Measurement of blood immune populations and microbiota distribution.

Patient with nephrotic syndrome no idiopathic, IgA or GEM type

Description:

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.

Treatment:

Other: Measurement of blood immune populations and microbiota distribution.