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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

Tracking Information
First Submitted Date November 2, 2016
First Posted Date November 3, 2016
Last Update Posted Date March 18, 2019
Actual Study Start Date August 28, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 2, 2016)
Expression profile of miRNAs in patients with AAV in circulating neutrophils, plasma and urine. [ Time Frame: 6 month after maintenance treatment ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02954705 on Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
50 mL of blood and 10 mL of urine by patient
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
Condition ANCA-associated Vasculitis
Intervention Other: Non interventional study
This is a non interventional study because all levies are performed during visit planned for the care of patients.
Study Groups/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.
    Intervention: 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

    Intervention: Other: Non interventional study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 2, 2016)
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
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
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contact: Sarah Bruneau, Dr
Contact: Fadi Fakhouri, Pr
Listed Location Countries France
Removed Location Countries  
Administrative Information
NCT Number NCT02954705
Other Study ID Numbers RC15_0454
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators INSERM UMRS-1064
Principal Investigator: Fadi Fakhouri, Pr Nantes University Hospital
PRS Account Nantes University Hospital
Verification Date March 2019