ANCA Associated VasculitisAVAC-EURNCT06794827
Early-access Avacopan in Real-world ANCA-associated Vasculitis
An observational study of ANCA Associated Vasculitis, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
The current study proposal aims to investigate the clinical practice variation of the initial use of avacopan for AAV patients in Europe. The study will describe patient characteristics and organ-specific clinical benefit of avacopan treatment in a unique, first-experience cohort of AAV patients. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- ANCA Associated Vasculitis
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A multicenter, non-interventional, longitudinal cohort study which will collect incident as well as prevalent AAV patients treated with an avacopan-based regimen. The cohort will include retrospective and prospective data capture on real-life management and outcomes.
Who may be able to join
- Established diagnosis of GPA or MPA
- Treatment (initiation) with avacopan
- Informed consent for use of medical data
Who cannot join
- If there is no AAV disease activity present that can be supported by an objectifiable clinical measure or assessment
- If a subject is below 16 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden
YKO Teng, MD, PhD, y.k.o.teng@Lumc.nl
About this study
Official title: Evaluating Clinical Practice of Early Access Avacopan Treatment for ANCA-associated Vasculitis in European Countries
The current study proposal aims to investigate the clinical practice variation of the initial use of avacopan for AAV patients in Europe. The study will describe patient characteristics and organ-specific clinical benefit of avacopan treatment in a unique, first-experience cohort of AAV patients. By studying the clinical practice variation of first-experience avacopan treatment, this study will be uniquely positioned to identify pivotal issues on the real-life implementation of avacopan treatment. These observational data can ultimately serve to address current knowledge gaps on avacopan treatment in AAV patients, improve the care and drug-access for AAV patients with avacopan treatment and generate new areas of research.
Read the detailed description
Objective: Analyse the clinical practice variation of the early access use of avacopan in real-world treated patients with ANCA-associated vasculitis.
Study design: Observational cohort study Study population: AAV patients treated with avacopan.
Main study parameters/endpoints:
- Describe physician's treatment indications for starting avacopan
- Describe AAV patients clinical characteristics
- Describe the concomitant treatment strategies employed with avacopan
- Describe clinical outcomes of avacopan treatment
- Investigate determinants of clinical benefit as well as non-response and/or relapse within the study cohort
- Conditions
- ANCA Associated Vasculitis
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess physician's treatment indications for starting avacopan as reported in the database questionnaire
Assess physician's treatment indications for starting avacopan as reported in the database questionnaire.
Options to choose are: Refractory disease, Relapsing disease, Steroid dependent, Steroid toxicity or Other
Measured: 1 year
Assess AAV patients' clinical characteristics at baseline as reported in the database questionnaire
Assess AAV patients' clinical characteristics at baseline as reported in the database questionnaire including:
Gender (Male/Female) Age Date of AAV diagnosis Type AAV (GPA or MPA) Autoantibodies (PR3 or MPO) Organs affected
Measured: 1 year
Assess concomitant immunosuppressive treatment strategies employed with avacopan as registered in the database questionnaire
Assess concomitant treatment strategies employed with avacopan at baseline, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months and 24 monhts.
Possible options include steroids, cyclophosphamide, rituximab, azathioprine or other
Measured: 1 year
Assess the relevant clinical benefit of avacopan treatment at the individual patient level based on the BVAS score [0-63]
Assess the relevant clinical benefit of avacopan treatment at the individual patient level based on the BVAS score [0-63] as reported at baseline, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months and 24 monhts.
Measured: 2 years
Secondary outcomes (1)
Investigate determinants of non-response and/or relapse upon avacopan treatment based on baseline characteristics registered in the database questionnaire
Investigate determinants of non-response and/or relapse upon avacopan treatment based on baseline characteristics registered in the database questionnaire including:
Gender (Male/Female) Age Date of AAV diagnosis Type AAV (GPA or MPA) Autoantibodies (PR3 or MPO) Organs affected
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Nov 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 Leiden University Medical CenterThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Udine, University of Modena and Reggio Emilia, Hospital Universitari de Bellvitge, ZOL Hospital Genk Belgium
- Responsible party
- Principal investigator, Y.K.Onno Teng, Leiden University Medical Center
- Investigators
- Y.K. Onno Teng, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794827
- Sponsor's protocol ID
- IIS-AVA-2023-0005
- Acronym
- AVAC-EUR
- Status last verified
- Jan 2025
- First submitted
- 1 Mar 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Clinical Practice of Early Access Avacopan Treatment for ANCA-associated Vasculitis in European Countries
- ClinicalTrials.gov ID
- NCT06794827
- Acronym / sponsor ID
- AVAC-EUR / IIS-AVA-2023-0005
- Conditions
- ANCA Associated Vasculitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- University of Udine, University of Modena and Reggio Emilia, Hospital Universitari de Bellvitge, ZOL Hospital Genk Belgium
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jan 2025 (actual)
- 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.
The current study proposal aims to investigate the clinical practice variation of the initial use of avacopan for AAV patients in Europe. The study will describe patient characteristics and organ-specific clinical benefit of avacopan treatment in a unique, first-experience cohort of AAV patients. By studying the clinical practice variation of first-experience avacopan treatment, this study will be uniquely positioned to identify pivotal issues on the real-life implementation of avacopan treatment. These observational data can ultimately serve to address current knowledge gaps on avacopan treatment in AAV patients, improve the care and drug-access for AAV patients with avacopan treatment and generate new areas of research.
Detailed description
Objective: Analyse the clinical practice variation of the early access use of avacopan in real-world treated patients with ANCA-associated vasculitis.
Study design: Observational cohort study Study population: AAV patients treated with avacopan.
Main study parameters/endpoints:
- Describe physician's treatment indications for starting avacopan
- Describe AAV patients clinical characteristics
- Describe the concomitant treatment strategies employed with avacopan
- Describe clinical outcomes of avacopan treatment
- Investigate determinants of clinical benefit as well as non-response and/or relapse within the study cohort
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A multicenter, non-interventional, longitudinal cohort study which will collect incident as well as prevalent AAV patients treated with an avacopan-based regimen. The cohort will include retrospective and prospective data capture on real-life management and outcomes.
Key inclusion criteria (3 listed)
- Established diagnosis of GPA or MPA
- Treatment (initiation) with avacopan
- Informed consent for use of medical data
Key exclusion criteria (2 listed)
- If there is no AAV disease activity present that can be supported by an objectifiable clinical measure or assessment
- If a subject is below 16 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess physician's treatment indications for starting avacopan as reported in the database questionnaire
Time frame: 1 year
Assess physician's treatment indications for starting avacopan as reported in the database questionnaire. Options to choose are: Refractory disease, Relapsing disease, Steroid dependent, Steroid toxicity or Other
Assess AAV patients' clinical characteristics at baseline as reported in the database questionnaire
Time frame: 1 year
Assess AAV patients' clinical characteristics at baseline as reported in the database questionnaire including: Gender (Male/Female) Age Date of AAV diagnosis Type AAV (GPA or MPA) Autoantibodies (PR3 or MPO) Organs affected
Assess concomitant immunosuppressive treatment strategies employed with avacopan as registered in the database questionnaire
Time frame: 1 year
Assess concomitant treatment strategies employed with avacopan at baseline, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months and 24 monhts. Possible options include steroids, cyclophosphamide, rituximab, azathioprine or other
Assess the relevant clinical benefit of avacopan treatment at the individual patient level based on the BVAS score [0-63]
Time frame: 2 years
Assess the relevant clinical benefit of avacopan treatment at the individual patient level based on the BVAS score [0-63] as reported at baseline, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months and 24 monhts.
1 secondary outcome
Investigate determinants of non-response and/or relapse upon avacopan treatment based on baseline characteristics registered in the database questionnaire
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Y.K. Onno Teng principal investigator
Leiden University Medical Center
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 Leiden University Medical Center at 1 site in Netherlands.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Y.K.O. Teng, MD, PhD (+31715262148, y.k.o.teng@Lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess physician's treatment indications for starting avacopan as reported in the database questionnaire (time frame: 1 year). The study lists 4 primary outcomes in all. 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 27 Jan 2025.