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

ANCA-associated Vasculitis Clinical Trial

— MINERVA  

Official title:

MICRO-RNAs OF NEUTROPHILS IN RENAL ANCA-ASSOCIATED VASCULITIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02954705
• Other study ID #: RC15_0454
• Status: Completed
• Start date: August 28, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ANCA-associated Vasculitis
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• 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.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	INSERM UMRS-1064

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression profile of miRNAs in patients with AAV in circulating neutrophils, plasma and urine.		6 month after maintenance treatment