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

Completed

• Conditions: ANCA-associated Vasculitis
• Interventions: Other: Non interventional study

• Registration Number: NCT02954705
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-03
• Study Start: 2017-08-28
• Primary Completion: 2019-12-31
• Study Completion: 2020-09-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group control	Non interventional study	People recruited from the "Etablissement français du sang" (French blood establishment ). 10 milliliter of blood are collected from these donors
Group AAV	Non interventional study	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.

Primary Outcome Measures

Name	Time	Method
Expression profile of miRNAs in patients with AAV in circulating neutrophils, plasma and urine.	6 month after maintenance treatment

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France