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

Completed

• Conditions: ANCA-associated Vasculitis

• 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

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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