Glomerulonephritis, IGALYMFONINCT05791162
Interest of Follicular Helper Lymphocytes / Regulatory Follicular Helper Lymphocytes Ratio in IgA Nephropathy
A study testing Blood collection and Urine sample in people with Glomerulonephritis, IGA, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glomerulonephritis, IGA
- What is being tested?
- Blood collection and Urine sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2023to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Legal incapacity or limited legal capacity
- Subjects with no social security coverage.
- Pregnancy / No effective contraceptive method
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Besançon
Besançon, 25000
About this study
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
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.
- Conditions
- Glomerulonephritis, IGA
- Being tested
- Blood collection, Urine sample
- Keywords
- Follicular helper T cells, Follicular regulatory T cells
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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)
| Study group | Role | What they receive |
|---|---|---|
| IgA nephropathy in follow-up (arm 1) | Other | Diagnosis of IgA nephropathy from 2009, with a minimum follow-up for nephropathy of 5 years Receives: Other: Blood collection; Other: Urine sample |
| Newly diagnosed IgA nephropathy (arm 2) | Other | Diagnosis of IgA nephropathy during the study period Receives: Other: Blood collection; Other: Urine sample |
| CD163s control (arm 3) | Other | Diagnosis of Lupus or ANCA-associated vasculitis or polycystic kidney disease Receives: Other: Urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start23 May 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerulonephritis, IGAStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melchior Chabannes, MD, Principal investigator, Nephrology, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791162
- Sponsor's protocol ID
- 2023/748
- Acronym
- LYMFONI
- Status last verified
- Nov 2024
- First submitted
- 17 Mar 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05791162
- Acronym / sponsor ID
- LYMFONI / 2023/748
- Conditions
- Glomerulonephritis, IGA
- Keywords
- Follicular helper T cells, Follicular regulatory T cells
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IgA nephropathy in follow-up (arm 1) | Other | Other: Blood collection, Other: Urine sampleDiagnosis of IgA nephropathy from 2009, with a minimum follow-up for nephropathy of 5 years |
| Newly diagnosed IgA nephropathy (arm 2) | Other | Other: Blood collection, Other: Urine sampleDiagnosis of IgA nephropathy during the study period |
| CD163s control (arm 3) | Other | Other: Urine sampleDiagnosis of Lupus or ANCA-associated vasculitis or polycystic kidney disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- Legal incapacity or limited legal capacity
- Subjects with no social security coverage.
- Pregnancy / No effective contraceptive method
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionCollection 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) | Other | IgA nephropathy in follow-up (arm 1), Newly diagnosed IgA nephropathy (arm 2) |
| Urine sampleCollection 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) | Other | CD163s control (arm 3), IgA nephropathy in follow-up (arm 1), Newly diagnosed IgA nephropathy (arm 2) |
Primary outcome
Form of IgA nephropathy exhibited by the patient (progressive or stable)
Time frame: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melchior Chabannes, MD principal investigator
Nephrology, CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection and Urine sample in people with Glomerulonephritis, IGA, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charline Vauchy, PhD. (0381218875, cvauchy@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Form of IgA nephropathy exhibited by the patient (progressive or stable) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.