Clinical trial NCT02954705: MICRO-RNAs OF NEUTROPHILS IN RENAL ANTINEUTROPHIL CYTOPLASMIS ANTIBODY (ANCA) -ASSOCIATED VASCULITIS
Official title: MICRO-RNAs OF NEUTROPHILS IN RENAL ANCA-ASSOCIATED VASCULITIS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ANCA-associated Vasculitis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2016-11-03
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief 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.


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

Primary outcomes:
measure: Expression profile of miRNAs in patients with AAV in circulating neutrophils, plasma and urine.
timeFrame: 6 month after maintenance treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Fadi Fakhouri, Pr
role: PRINCIPAL_INVESTIGATOR
References: