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

Glomerulonephritis, IGA Clinical Trial

— LYMFONI  

Official title:

Interest of Follicular Helper Lymphocytes / Regulatory Follicular Helper Lymphocytes Ratio to Characterize and Predict Poor Prognosis Forms in IgA Nephropathy: an Exploratory Proof-of-concept Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05791162
• Other study ID #: 2023/748
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: May 2026

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Charline Vauchy, PhD.
• Phone: 0381218875
• Email: cvauchy[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulonephritis, IGA

Intervention

Other:
• Blood collection
Collection of 3 blood tubes at inclusion and relapse (arm 1) or at inclusion, initiation of treatment and at 3 and 6 months post-diagnosis (arm 2)
• Urine sample
Collection of 20 cc of urine at inclusion and relapse (arm 1) or at inclusion, initiation of treatment and at 3 and 6 months post-diagnosis (arm 2) or at inclusion only (arm 3)

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Form of IgA nephropathy exhibited by the patient (progressive or stable)	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.	12 months