Investigating T cell ratios in patients with 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
This study is testing if measuring certain types of immune cells in the blood can help doctors tell the difference between stable and worsening IgA nephropathy in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Besancon Academic / other |
| Locations | 1 site (Besançon) |
| Trial ID | NCT05791162 on ClinicalTrials.gov |
What this trial studies
This study examines the ratio of follicular helper T cells to regulatory follicular helper T cells in patients diagnosed with IgA nephropathy. It aims to differentiate between stable and progressive forms of the disease by analyzing blood and urine samples. The study will also seek to predict the clinical evolution of the disease within the first year of diagnosis. Participants will include patients with confirmed IgA nephropathy and control patients with other kidney conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed IgA nephropathy and a minimum follow-up of five years or newly diagnosed patients during the study.
Not a fit: Patients with legal incapacity, those without social security coverage, or pregnant individuals may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic tools for patients with IgA nephropathy, allowing for better management of the disease.
How similar studies have performed: While the specific approach of analyzing Tfh/Tfr ratios in IgA nephropathy is novel, similar studies in other conditions have shown promise in understanding immune responses.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Besançon
- Centre Hospitalier Universitaire de Besançon — Besançon, France (Recruiting)
Study contacts
- Principal investigator: Melchior Chabannes, MD — Nephrology, CHU Besançon
- Study coordinator: Charline Vauchy, PhD.
- Email: cvauchy@chu-besancon.fr
- Phone: 0381218875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.