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CompletedNCT03698071VASC-FASUpdated Aug 17, 2026

Soluble CD95 Ligand Role in the Pathophysiology of Antineutrophil Cytoplasmic Antibody (ANCA) Associated Vasculitis

An interventional study of blood sample and urine sample in ANCA Associated Vasculitis, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The study aims at defining the role of soluble CD95 Ligand in the physiopathology of a rare group of inflammatory diseases: ANCA associated vasculitis. Soluble CD95 Ligand might have a prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.

Read the detailed description

ANCA associated vasculitis are a rare group of diseases and potentially life-threatening inflammatory conditions. There is an urgent need to describe prognostic factors and to discover new therapeutic pathways. Soluble CD95-L is a cleaved part of CD95-L which binds the CD95 Death receptor. s-CD95-L has pro-inflammatory properties for Th17 lymphocytes and Neutrophils, two cells implicated in ANCA associated vasculitis. It also plays a role in systemic lupus erythematosus (which present with the same type of renal glomerulonephritis as ANCA-associated vasculitis). Finally, it has already be found elevated in this group of diseases. The investigators hypothesized that s-CD95-L levels might be a prognostic factor in ANCA associated vasculitis and the study of the molecular mechanisms involved could provide new therapeutic targets.

The study will recruit 50 patients with ANCA associated vasculitis followed in Bordeaux University Hospital. Among classical disease activity information, blood and urine samples will be collected at each visit to study s-CD95-L. Fundamental research will be realized on patients' sample to study molecular mechanisms involved.

Clinical and biological disease activity, treatment and outcomes will be studied in correlation with s-CD95-L to describe their potential prognostic role. Patients will be followed at regular intervals, as their usual follow-up would request. No extra visit will be needed and blood samples will be drawn at the same time as those drawn for clinical purposes.

02

Conditions studied

  • ANCA Associated Vasculitis

Keywords

  • ANCA associated vasculitis
  • Granulomatosis with polyangiitis
  • microscopic polyangiitis
  • eosinophilic granulomatosis with polyangiitis
  • soluble-CD95-Ligand
03

In context

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

157 studies on the registry are indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; 75 are open to participants now.

This study's enrollment of 48 is above the median of 34 across 116 interventional studies indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.

Browse Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of ANCA associated vasculitis according to the Chapel-Hill Consensus Conference - 2012 modified version
  • Age ≥ 18 years
  • being affiliated to health insurance
  • willing to participate and to sign .

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding women,
  • patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    ANCA associated vasculitis

    Biological: blood sample · Biological: urine sample

Interventions

  • Biologicalblood sample

    30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

  • Biologicalurine sample

    6 ml

06

What researchers measure

Primary outcomes

  1. Change of quantitative levels of s-CD95-L in ANCA associated vasculitis between baseline and Month 12

    Time frame: At baseline (Day 0) and 12 months from baseline

Secondary outcomes

  1. Change of disease activity scores for ANCA associated vasculitis between baseline and Month 12

    Birmingham Vasculitis Activity Score - Version 3 (BVAS 3.0) The Birmingham Vasculitis Activity Score (BVAS) is a method for assessing the activity of vasculitis. Note that scoring ranges are higher when any of the features are new or worse. Creatinine levels can be scored at patient's first assessment only. The maximum score is 63 points for present symptoms and 32 points for new symptoms or symptoms which had worsened within the previous weeks.

    Time frame: At baseline (Day 0) and 12 months from baseline

  2. Change of disease activity scores for ANCA associated vasculitis between baseline and Month 12

    Vasculitis Damage Index (VDI)

    Time frame: At baseline (Day 0) and 12 months from baseline

  3. Change of quantification of s-CD95-L in the blood and urine samples of ANCA associated vasculitis between baseline and Month 12

    Time frame: At baseline (Day 0) and 12 months from baseline

  4. Change of quantification of ANCA in the blood samples of ANCA associated vasculitis between baseline and Month 12

    Time frame: At baseline (Day 0) and 12 months from baseline

07

Study locations

1 site
  • CHU de Bordeaux - Service d'Immunologie et Immunogénétique
    Bordeaux, France
08

References and documents

Publications

  • Boizard-Moracchini A, Msalbi D, Huot-Marchand S, Haymour L, Lebrault E, Tchen J, Jekel T, Galli G, Brilland B, Merillon N, Josensi C, Lozano C, Mazars J, Douard M, Danger Y, Verite F, Barnetche T, Lazaro E, Duffau P, Pfirmann P, Magerus-Chatinet A, Jean M, Augusto JF, Armengaud J, Richez C, Vacher P, Legembre P, Blanco P. Soluble CD95L triggers Caspase-10-driven reactive oxygen species production in neutrophils and aggravates anti-neutrophil cytoplasmic antibody-vasculitis. Nat Commun. 2026 Jun 20;17(1):7759. doi: 10.1038/s41467-026-74452-8. PubMed 42321206 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2018 to primary completion in Sep 2024, 69 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2018
First posted
Oct 5, 2018
StartActual
Dec 14, 2018
Primary completionActual
Sep 18, 2024
CompletionActual
Sep 18, 2024
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03698071
Collaborators
National Research Agency, France
Responsible party
Sponsor
First posted
Oct 5, 2018
Start date
Dec 14, 2018
Primary completion
Sep 18, 2024
Completion
Sep 18, 2024
Last update
Aug 17, 2026

Study contacts

Patrick BLANCO, Prof
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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