MINERVA: MICRO-RNAs OF NEUTROPHILS IN RENAL ANTINEUTROPHIL CYTOPLASMIS ANTIBODY (ANCA) -ASSOCIATED VASCULITIS
Study Details
Study Description
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 | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Expression profile of miRNAs in patients with AAV in circulating neutrophils, plasma and urine. [6 month after maintenance treatment]
Eligibility Criteria
Criteria
Inclusion Criteria for patients:
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Adult patients aged over 18 years
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Patients with Granulomatosis with polyangiitis or microscopic polyangiitis meeting the criteria of Chapel Hill.
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corticosteroid treatment <20 mg / day.
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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:
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ANCA-associated vasculitis with Eosinophilic granulomatosis with polyangiitis (AAV-EGPA).
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Infectious or progressive tumor pathology.
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Pregnancy, lactation
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Treatment with cyclophosphamide in the 6 months prior to inclusion.
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Terminal chronic renal failure, presence of organ allograft.
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Thrust Patients receiving corticosteroids> 20 mg / d in the previous 4 weeks.
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Inability to give informed about information (subject in emergencies, understanding of the subject of difficulty, ...)
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Minor subject, under judicial protection, guardianship
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nantes University Hospital | Nantes | France | 44093 |
Sponsors and Collaborators
- Nantes University Hospital
- INSERM UMRS-1064
Investigators
- Principal Investigator: Fadi Fakhouri, Pr, Nantes University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC15_0454