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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02954705
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : March 18, 2019
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment
ANCA-associated Vasculitis Other: Non interventional study

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Prospective
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasculitis

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

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

Primary Outcome Measures :
  1. Expression profile of miRNAs in patients with AAV in circulating neutrophils, plasma and urine. [ Time Frame: 6 month after maintenance treatment ]

Biospecimen Retention:   Samples Without DNA
50 mL of blood and 10 mL of urine by patient

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02954705

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Contact: Sarah Bruneau, Dr
Contact: Fadi Fakhouri, Pr

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Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Fadi Fakhouri, Pr   
Sponsors and Collaborators
Nantes University Hospital
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Principal Investigator: Fadi Fakhouri, Pr Nantes University Hospital

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Responsible Party: Nantes University Hospital Identifier: NCT02954705     History of Changes
Other Study ID Numbers: RC15_0454
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Vascular Diseases
Cardiovascular Diseases
Systemic Vasculitis
Autoimmune Diseases
Immune System Diseases