Actively Recruiting
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
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2024-11-21
75
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the ratio of Follicular helper T cells to Follicular regulatory T cells (Tfh/Tfr) in people with IgA nephropathy, a kidney condition. The study aims to find differences in this ratio between patients whose disease is stable and those whose disease progresses. It also seeks to predict how the disease will evolve within the first year after diagnosis. The study includes three groups: patients diagnosed with IgA nephropathy since 2009 who have been followed for at least 5 years, patients newly diagnosed during the study, and control patients with other kidney diseases like Lupus, ANCA-associated vasculitis, or polycystic kidney disease. Blood and urine samples are collected at various points, including at study entry, during relapse, at treatment start, and at 3 and 6 months after diagnosis. Participants will have blood and urine collected multiple times depending on their group to analyze the Tfh/Tfr ratio and other markers. Researchers will monitor the disease form (stable or progressive) over 12 months to understand clinical outcomes. The study runs until May 2026, with assessments focused on early prediction of disease progression using these biological markers.
CONDITIONS
Brief Title
Interest of Follicular Helper Lymphocytes / Regulatory Follicular Helper Lymphocytes Ratio in IgA Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically proven IgA nephropathy on renal biopsy according to KDIGO criteria
- Patients diagnosed from 2009 with at least 5 years of nephropathy follow-up (arm 1)
- Patients diagnosed during the study period (arm 2)
- Control patients with Lupus, ANCA-associated vasculitis, or polycystic kidney disease (arm 3)
You will not qualify if you...
- Legal incapacity or limited legal capacity
- No social security coverage
- Pregnancy or no effective contraceptive method
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months
Participants provide blood and urine samples at specified time points depending on their cohort assignment.
1 to 4 visits depending on cohort and timing
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire de Besançon
Besançon, France, 25000
Actively Recruiting
Research Team
C
Charline Vauchy, PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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