Interest of Follicular Helper Lymphocytes / Regulatory Follicular Helper Lymphocytes Ratio in IgA Nephropathy

Not Applicable

Recruiting

• Conditions: Glomerulonephritis, IGA
• Interventions: Other: Urine sample; Other: Blood collection

• Registration Number: NCT05791162
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

This study aims to investigate the relevance of the Tfh/Tfr (Follicular helper T cells/ Follicular regulatory T cells) ratio in patients with IgA nephropathy:

* To identify a differential expression of the Tfh/Tfr ratio in patients considered stable or progressive

* To predict, at diagnosis, the clinical evolution of the disease (progressive or stable form) in the first year.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-03-17
• Study First Posted: 2023-03-30
• Study Start: 2023-05-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• IgA nephropathy histologically proven on renal biopsy according to KDIGO criteria, with 8 permeable glomeruli (patients diagnosed from 2009 with a minimum follow-up for their nephropathy of 5 years (arm 1) or patients diagnosed during the study (arm 2))

Control patients: Lupus or ANCA-associated vasculitis or polycystic kidney disease (arm 3)

Exclusion Criteria

• Legal incapacity or limited legal capacity
• Subjects with no social security coverage.
• Pregnancy / No effective contraceptive method

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD163s control (arm 3)	Urine sample	Diagnosis of Lupus or ANCA-associated vasculitis or polycystic kidney disease
IgA nephropathy in follow-up (arm 1)	Blood collection	Diagnosis of IgA nephropathy from 2009, with a minimum follow-up for nephropathy of 5 years
Newly diagnosed IgA nephropathy (arm 2)	Urine sample	Diagnosis of IgA nephropathy during the study period
IgA nephropathy in follow-up (arm 1)	Urine sample	Diagnosis of IgA nephropathy from 2009, with a minimum follow-up for nephropathy of 5 years
Newly diagnosed IgA nephropathy (arm 2)	Blood collection	Diagnosis of IgA nephropathy during the study period

Primary Outcome Measures

Name	Time	Method
Form of IgA nephropathy exhibited by the patient (progressive or stable)	12 months	Patient with a diagnosis before the start of the study: IgA nephropathy with a GFR of less than 45 ml/min/1.73 m2 and/or proteinuria \>0.5 g/day and/or hematuria (microscopic or macroscopic) will be considered progressive.; Patient with diagnosis during the study: will be considered as progressive an IgA nephropathy for which the GFR will decrease compared to the inclusion (diagnosis) of more than 5 ml/min/1.73 m2 and/or with a proteinuria \>0.5 g/day and/or with a microscopic hematuria on at least one of the samples carried out in a period of one year after the diagnosis.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Besançon; 🇫🇷 Besançon, France