Back to resultsInterest of Follicular Helper Lymphocytes / Regulatory Follicular Helper Lymphocytes Ratio in IgA Nephropathy (LYMFONI)
Primary Purpose
Glomerulonephritis, IGA
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood collection
Urine sample
Sponsored by
About this trial
This is an interventional basic science trial for Glomerulonephritis, IGA focused on measuring Follicular helper T cells, Follicular regulatory T cells
Eligibility 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
Sites / Locations
- Centre Hospitalier Universitaire de BesançonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
IgA nephropathy in follow-up (arm 1)
Newly diagnosed IgA nephropathy (arm 2)
CD163s control (arm 3)
Arm Description
Diagnosis of IgA nephropathy from 2009, with a minimum follow-up for nephropathy of 5 years
Diagnosis of IgA nephropathy during the study period
Diagnosis of Lupus or ANCA-associated vasculitis or polycystic kidney disease
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05791162
First Posted
March 17, 2023
Last Updated
July 21, 2023
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT05791162
Brief Title
Interest of Follicular Helper Lymphocytes / Regulatory Follicular Helper Lymphocytes Ratio in IgA Nephropathy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulonephritis, IGA
Keywords
Follicular helper T cells, Follicular regulatory T cells
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IgA nephropathy in follow-up (arm 1)
Arm Type
Other
Arm Description
Diagnosis of IgA nephropathy from 2009, with a minimum follow-up for nephropathy of 5 years
Arm Title
Newly diagnosed IgA nephropathy (arm 2)
Arm Type
Other
Arm Description
Diagnosis of IgA nephropathy during the study period
Arm Title
CD163s control (arm 3)
Arm Type
Other
Arm Description
Diagnosis of Lupus or ANCA-associated vasculitis or polycystic kidney disease
Intervention Type
Other
Intervention Name(s)
Blood collection
Intervention Description
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
Intervention Name(s)
Urine sample
Intervention Description
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)
Primary Outcome Measure Information:
Title
Form of IgA nephropathy exhibited by the patient (progressive or stable)
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charline Vauchy, PhD.
Phone
0381218875
Email
cvauchy@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melchior Chabannes, MD
Organizational Affiliation
Nephrology, CHU Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Interest of Follicular Helper Lymphocytes / Regulatory Follicular Helper Lymphocytes Ratio in IgA Nephropathy
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