LYMFONI: Interest of Follicular Helper Lymphocytes / Regulatory Follicular Helper Lymphocytes Ratio in IgA Nephropathy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: IgA nephropathy in follow-up (arm 1) Diagnosis of IgA nephropathy from 2009, with a minimum follow-up for nephropathy of 5 years |
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)
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)
|
| Other: Newly diagnosed IgA nephropathy (arm 2) Diagnosis of IgA nephropathy during the study period |
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)
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)
|
| Other: CD163s control (arm 3) Diagnosis of Lupus or ANCA-associated vasculitis or polycystic kidney disease |
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)
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire de Besançon | Besançon | France | 25000 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Besancon
Investigators
- Principal Investigator: Melchior Chabannes, MD, Nephrology, CHU Besançon
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023/748