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

Not Applicable

Recruiting

• Conditions: Glomerulonephritis, IGA

• 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

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