NCT02954705

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

August 28, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

2.3 years

First QC Date

November 2, 2016

Last Update Submit

October 21, 2020

Conditions

ANCA-associated Vasculitis

Outcome Measures

Primary Outcomes (1)

  • Expression profile of miRNAs in patients with AAV in circulating neutrophils, plasma and urine.

    6 month after maintenance treatment

Study Arms (2)

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

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

Interventions

Non interventional studyOTHER

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

Group AAVGroup control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This will be done in total in 50 patients with ANCA-associated vasculitis (AAV) and 20 control patients. Among the 50 patients with AAV, 30 patients will be newly diagnosed and 20 already followed for AAV

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

50 mL of blood and 10 mL of urine by patient

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Condition Hierarchy (Ancestors)

Systemic VasculitisVasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Fadi Fakhouri, Pr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 3, 2016

Study Start

August 28, 2017

Primary Completion

December 31, 2019

Study Completion

September 30, 2020

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)