NCT05791162

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 23, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

2.9 years

First QC Date

March 17, 2023

Last Update Submit

November 19, 2024

Conditions

Glomerulonephritis, IGA

Keywords

Follicular helper T cellsFollicular regulatory T cells

Outcome Measures

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.

    12 months

Study Arms (3)

IgA nephropathy in follow-up (arm 1)

OTHER

Diagnosis of IgA nephropathy from 2009, with a minimum follow-up for nephropathy of 5 years

Other: Blood collectionOther: Urine sample

Newly diagnosed IgA nephropathy (arm 2)

OTHER

Diagnosis of IgA nephropathy during the study period

Other: Blood collectionOther: Urine sample

CD163s control (arm 3)

OTHER

Diagnosis of Lupus or ANCA-associated vasculitis or polycystic kidney disease

Other: Urine sample

Interventions

Blood collectionOTHER

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)

IgA nephropathy in follow-up (arm 1)Newly diagnosed IgA nephropathy (arm 2)
Urine sampleOTHER

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)

CD163s control (arm 3)IgA nephropathy in follow-up (arm 1)Newly diagnosed IgA nephropathy (arm 2)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Legal incapacity or limited legal capacity
  • Subjects with no social security coverage.
  • Pregnancy / No effective contraceptive method

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Melchior Chabannes, MD

    Nephrology, CHU Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charline Vauchy, PhD.

CONTACT

0381218875cvauchy@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2023

First Posted

March 30, 2023

Study Start

May 23, 2023

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

November 21, 2024

Record last verified: 2024-11

Locations

FR(1)