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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Besancon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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))

Disqualifiers

Legal incapacity or limited legal capacity

Subjects with no social security coverage.

Pregnancy / No effective contraceptive method

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood collection

    Other intervention

    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

    Other intervention

    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)

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: IgA nephropathy in follow-up (arm 1)Other 2 interventions
Group B: Newly diagnosed IgA nephropathy (arm 2)Other 2 interventions
Group C: CD163s control (arm 3)Other 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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