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Completed

NCT Number: NCT02954705

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

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.

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Key information

Conditions

ANCA-associated Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Cardiovascular Diseases Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non interventional study

Other

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

Primary outcomes

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

    Time frame: 6 month after maintenance treatment

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

MICRO-RNAs OF NEUTROPHILS IN RENAL ANCA-ASSOCIATED VASCULITIS

Acronym: MINERVA

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 3, 2016
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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