Exploring the role of immune cells and gut bacteria in idiopathic nephrotic syndrome
Controlled Multicenter Epidemiological Study of Peripheral Leukocyte Populations and Microbiota in Patients With Idiopathic Nephrotic Syndrome (INS)
This study is trying to see how immune cells and gut bacteria affect people with idiopathic nephrotic syndrome during kidney problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 2 sites (Nantes, Loire-Atlantique and 1 other locations) |
| Trial ID | NCT04924712 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between immune system components, specifically B-lymphocytes and regulatory T cells, and the microbiota in patients suffering from idiopathic nephrotic syndrome (INS). It aims to measure blood immune populations and microbiota distribution during nephrotic attacks, which are characterized by significant proteinuria. The study seeks to understand the underlying mechanisms of this kidney disease, which can lead to chronic renal failure and complications post-kidney transplantation.
Who should consider this trial
Good fit: Ideal candidates for this study are patients currently experiencing a nephrotic attack with significant proteinuria.
Not a fit: Patients with a history of nephrotic syndrome flare-ups resistant to corticosteroid therapy or those currently on immunosuppressants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of idiopathic nephrotic syndrome, potentially reducing the frequency and severity of flare-ups.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated a potential link between immune dysfunction and nephrotic syndrome, suggesting that exploring these connections may yield valuable insights.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Nantes, Loire-Atlantique and 1 other locations
- Nantes University Hospital — Nantes, Loire-Atlantique, France (Recruiting)
- Departemental Hospital Center — La Roche-sur-Yon, France (Recruiting)
Study contacts
- Study coordinator: Christophe Masset
- Email: christophe.masset@chu-nantes.fr
- Phone: +33 2 76 64 39 61
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.