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

NCT ID: NCT05791162

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-23

Study Completion Date

2026-05-31

Brief Summary

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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

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Conditions

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Glomerulonephritis, IGA

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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IgA nephropathy in follow-up (arm 1)

Diagnosis of IgA nephropathy from 2009, with a minimum follow-up for nephropathy of 5 years

Group Type OTHER

Blood collection

Intervention Type OTHER

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

Intervention Type OTHER

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)

Newly diagnosed IgA nephropathy (arm 2)

Diagnosis of IgA nephropathy during the study period

Group Type OTHER

Blood collection

Intervention Type OTHER

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

Intervention Type OTHER

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)

CD163s control (arm 3)

Diagnosis of Lupus or ANCA-associated vasculitis or polycystic kidney disease

Group Type OTHER

Urine sample

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melchior Chabannes, MD

Role: PRINCIPAL_INVESTIGATOR

Nephrology, CHU Besançon

Locations

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Centre Hospitalier Universitaire de Besançon

Besançon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Charline Vauchy, PhD.

Role: CONTACT

0381218875

Other Identifiers

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2023/748

Identifier Type: -

Identifier Source: org_study_id

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