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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05791162
Acronym
LYMFONI
Enrollment
75
Registered
2023-03-30
Start date
2023-05-23
Completion date
2026-05-31
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glomerulonephritis, IGA

Keywords

Follicular helper T cells, Follicular regulatory T cells

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.

Interventions

OTHERBlood 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)

OTHERUrine 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)

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Form of IgA nephropathy exhibited by the patient (progressive or stable)12 monthsPatient 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.

Countries

France

Contacts

Primary ContactCharline Vauchy, PhD.
cvauchy@chu-besancon.fr0381218875

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026