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NCT Number: NCT04924712

INS, B Cells and Microbiota

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

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital, Nantes, Loire-Atlantique, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Sequencing and analysis of blood peripheral immune populations and intestinal and urinary microbiota

    Time frame: 3 months

    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.

  2. Sequencing and analysis of intestinal microbiota

    Time frame: 3 months

    The microbiota will be analyzed using DNA extracted from fecal samples.

  3. Sequencing and analysis of urinary microbiota

    Time frame: 3 months

    The microbiota will be analyzed using DNA extracted from urine samples.

Secondary outcomes

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

    Time frame: 3 months

    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.

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

    Time frame: 3 months

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

    Time frame: 3 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Masset

CONTACT

[email protected]

+33 2 76 64 39 61

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 14, 2021
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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