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

NCT ID: NCT02954705

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-28
• Study Completion Date: 2020-09-30

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.

Conditions

ANCA-associated Vasculitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Non interventional study

Intervention Type: OTHER

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

Non interventional study

Intervention Type: OTHER

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

Interventions

Non interventional study

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fadi Fakhouri, Pr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Nantes University Hospital

Nantes, , France

Countries

France

Other Identifiers

RC15_0454

Identifier Type: -

Identifier Source: org_study_id