ANCA-associated VasculitisMINERVANCT02954705
MICRO-RNAs OF NEUTROPHILS IN RENAL ANTINEUTROPHIL CYTOPLASMIS ANTIBODY (ANCA) -ASSOCIATED VASCULITIS
An observational study of ANCA-associated Vasculitis, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ANCA-associated Vasculitis
- What is being tested?
- Non interventional study
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2017to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
- Non Inclusion Criteria:
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MICRO-RNAs OF NEUTROPHILS IN RENAL 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.
- Conditions
- ANCA-associated Vasculitis
- Being tested
- Non interventional study
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyOther
This is a non interventional study because all levies are performed during visit planned for the care of patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression profile of miRNAs in patients with AAV in circulating neutrophils, plasma and urine.
Measured: 6 month after maintenance treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study start28 Aug 2017
- Primary completion31 Dec 2019
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA-associated VasculitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fadi Fakhouri, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954705
- Sponsor's protocol ID
- RC15_0454
- Acronym
- MINERVA
- Status last verified
- Oct 2020
- First submitted
- 2 Nov 2016
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MICRO-RNAs OF NEUTROPHILS IN RENAL ANCA-ASSOCIATED VASCULITIS
- ClinicalTrials.gov ID
- NCT02954705
- Acronym / sponsor ID
- MINERVA / RC15_0454
- Conditions
- ANCA-associated Vasculitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group AAV | – | Other: Non interventional studyPatients recruited from the Nantes University Hospital. 50 milliliter of blood and 10mL of urine are collected from these patients during levies in clinical visit. |
| Group control | – | Other: Non interventional studyPeople recruited from the "Etablissement français du sang" (French blood establishment ). 10 milliliter of blood are collected from these donors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventional studyThis is a non interventional study because all levies are performed during visit planned for the care of patients. | Other | Group AAV, Group control |
Primary outcome
Expression profile of miRNAs in patients with AAV in circulating neutrophils, plasma and urine.
Time frame: 6 month after maintenance treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fadi Fakhouri, Pr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ANCA-associated Vasculitis, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression profile of miRNAs in patients with AAV in circulating neutrophils, plasma and urine. (time frame: 6 month after maintenance treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.