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CompletedNCT02954705MINERVAUpdated Oct 22, 2020

MICRO-RNAs OF NEUTROPHILS IN RENAL ANTINEUTROPHIL CYTOPLASMIS ANTIBODY (ANCA) -ASSOCIATED VASCULITIS

An observational study in ANCA-associated Vasculitis, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
63
Ages
18 Years and older
Sex
All
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Study summary

Activation of neutrophils by ANCA ("Anti-Neutrophil Cytoplasm Antibodies") and subsequent microvascular endothelial cell damage is the main feature of ANCA-associated vasculitis (AAV), a severe autoimmune disease that often targets the kidney. There is no specific treatment for AAV to date and 25% of patients with renal damage evolve towards end-stage renal disease, requiring dialysis and kidney transplantation. In addition, there is no reliable biological marker of the disease activity available, which makes the diagnostic, follow-up and treatment of patients difficult. Therefore, the identification of new therapeutic targets and non-invasive biomarkers constitutes a major clinical challenge to improve AAV patients care and to ameliorate their renal outcome.

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Conditions studied

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In context

Vasculitis

230 studies on the registry are indexed under Vasculitis; 68 are open to participants now.

This study's enrollment of 63 is below the median of 149 across 104 observational studies indexed under Vasculitis.

Browse Vasculitis studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

This will be done in total in 50 patients with ANCA-associated vasculitis (AAV) and 20 control patients. Among the 50 patients with AAV, 30 patients will be newly diagnosed and 20 already followed for AAV

Eligibility criteria

Inclusion Criteria for patients:

  • Adult patients aged over 18 years
  • Patients with Granulomatosis with polyangiitis or microscopic polyangiitis meeting the criteria of Chapel Hill.
  • corticosteroid treatment \<20 mg / day.
  • Informed consent: oral for participation in research and writing for biological collection.

Inclusion Criteria for controls patients:

  • healthy-topics matched for age, recruited from the Etablissement français du sang or in the Department of Internal Medicine of Nantes University Hospital

Non Inclusion Criteria:

  • ANCA-associated vasculitis with Eosinophilic granulomatosis with polyangiitis (AAV-EGPA).
  • Infectious or progressive tumor pathology.
  • Pregnancy, lactation
  • Treatment with cyclophosphamide in the 6 months prior to inclusion.
  • Terminal chronic renal failure, presence of organ allograft.
  • Thrust Patients receiving corticosteroids> 20 mg / d in the previous 4 weeks.
  • Inability to give informed about information (subject in emergencies, understanding of the subject of difficulty, ...)
  • Minor subject, under judicial protection, guardianship
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
63 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Group AAV

    Patients recruited from the Nantes University Hospital. 50 milliliter of blood and 10mL of urine are collected from these patients during levies in clinical visit.

    Other: Non interventional study

  • Group control

    People recruited from the "Etablissement français du sang" (French blood establishment ). 10 milliliter of blood are collected from these donors

    Other: Non interventional study

Interventions

  • OtherNon interventional study

    This is a non interventional study because all levies are performed during visit planned for the care of patients.

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What researchers measure

Primary outcomes

  1. Expression profile of miRNAs in patients with AAV in circulating neutrophils, plasma and urine.

    Time frame: 6 month after maintenance treatment

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Study locations

1 site
  • Nantes University Hospital
    Nantes, 44093, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02954705
Lead sponsor
Nantes University Hospital
Collaborators
INSERM UMRS-1064
Responsible party
Sponsor
First posted
Nov 3, 2016
Start date
Aug 28, 2017
Primary completion
Dec 31, 2019
Completion
Sep 30, 2020
Last update
Oct 22, 2020

Study contacts

Fadi Fakhouri, Pr
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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