ANCA Associated VasculitisNCT05315141
Multicenter Cohort Study of AAV in Hunan of China
An observational study of ANCA Associated Vasculitis, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This study aimed to explore the incidence of Anti-neutrophil cytoplasmic antibody (ANCA）-associated vasculitis (AAV) progression and its association with adverse consequences. It will enroll approximately 500 AAV patients in Hunan province of China and follow-up for at least 5 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ANCA Associated Vasculitis
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2022to 16 Mar 2027
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study enrolled all the AAV patients that fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed
Who may be able to join
- Fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed consent
Who cannot join
- Do not agree to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiangya hospital
Changsha, Hunan, 410008
Yong Zhong, doctor, +86073189753025, zhongyong121@163.com
Ting Meng, doctor, +86073184327431, mengting252@163.com
About this study
Official title: Multicenter Cohort Study of ANCA-associated Small Vasculitis in Hunan Province of China
This study aimed to explore the incidence of Anti-neutrophil cytoplasmic antibody (ANCA）-associated vasculitis (AAV) progression and its association with adverse consequences. It will enroll approximately 500 AAV patients in Hunan province of China and follow-up for at least 5 years. Demographic characteristics, clinical and laboratory data will be collected at baseline and every follow-up. The principal clinical outcomes of the study consist of end stage renal disease (ESRD) and death.
Read the detailed description
The study is a multicenter prospective cohort study, aimed to explore the incidence of AAV and its progression and association with adverse consequences. The study will establish a baseline cohort of 500 AAV patients in Hunan province of China. The follow-up will be conducted for at least 5 years until death or starting renal replacement therapy or dropout. Their demographic characteristics, clinical data, laboratory and imaging examinations will be collected at baseline and every follow-up.
The baseline visit includes the following items: detailed demographics, medical and family history, medication history, health behaviors, physical activity, and anthropometric measures. The laboratory parameters of chemistry test. After the baseline visit, participants will return annually for follow-up visits and evaluation. The evaluating items of follow-up visits are similar to the baseline visit, and sample collection.
The principal clinical outcomes of the study can be broadly categorized as end stage renal disease and death. Death is further clarified as cardiac, infectious, renal, others, or unknown.
- Conditions
- ANCA Associated Vasculitis
- Being tested
- No Intervention
- Keywords
- ANCA Associated Vasculitis, ESRD, Outcome
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Xiangya Hospital | Not described Receives: Other: No Intervention | |
| The Second Xiangya Hospital | Not described Receives: Other: No Intervention | |
| The Third Xiangya Hospital | Not described Receives: Other: No Intervention | |
| Hunan Provincial People's Hospital | Not described Receives: Other: No Intervention | |
| Xiangtan Central Hospital | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
death from any cause
Measured: from date of baseline examination until the date of death from any cause, up to 60 months
End stage renal disease or significant loss of renal function
start of chronic dialysis or renal transplantation or irreversible development of glomerular filtration rate <15 ml/minute per 1.73m(2)
Measured: from date of baseline examination until the date of first documented end stage renal disease or date of death from any cause, whichever came first, up to 60 months
Secondary outcomes (2)
Disease activity
assessed by the proportion of patients with severe flares
Measured: Five years
Adverse events
- deaths (from all causes); b. grade 3 or higher infections; c. malignant conditions; d. venous thromboembolic events; e. cardiovascular events; f. hospitalizations
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start16 Mar 2022
- Primary completion16 Mar 2027 (estimated)
- Study completion16 Mar 2027 (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 Xiangya Hospital of Central South UniversityThe 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
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Central South University, The Third Xiangya Hospital of Central South University, Hunan Provincial People's Hospital, Xiangtan Central Hospital
- Responsible party
- Principal investigator, Xiangcheng Xiao, Xiangya Hospital of Central South University
- Investigators
- Xiangcheng Xiao, doctor, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315141
- Sponsor's protocol ID
- 202108374
- Status last verified
- Apr 2022
- First submitted
- 16 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Cohort Study of ANCA-associated Small Vasculitis in Hunan Province of China
- ClinicalTrials.gov ID
- NCT05315141
- Acronym / sponsor ID
- 202108374
- Conditions
- ANCA Associated Vasculitis
- Keywords
- ANCA Associated Vasculitis, ESRD, Outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Central South University, The Third Xiangya Hospital of Central South University, Hunan Provincial People's Hospital, Xiangtan Central Hospital
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 16 Mar 2027 (estimated)
- Study completion
- 16 Mar 2027 (estimated)
- First posted
- 7 Apr 2022 (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.
This study aimed to explore the incidence of Anti-neutrophil cytoplasmic antibody (ANCA）-associated vasculitis (AAV) progression and its association with adverse consequences. It will enroll approximately 500 AAV patients in Hunan province of China and follow-up for at least 5 years. Demographic characteristics, clinical and laboratory data will be collected at baseline and every follow-up. The principal clinical outcomes of the study consist of end stage renal disease (ESRD) and death.
Detailed description
The study is a multicenter prospective cohort study, aimed to explore the incidence of AAV and its progression and association with adverse consequences. The study will establish a baseline cohort of 500 AAV patients in Hunan province of China. The follow-up will be conducted for at least 5 years until death or starting renal replacement therapy or dropout. Their demographic characteristics, clinical data, laboratory and imaging examinations will be collected at baseline and every follow-up.
The baseline visit includes the following items: detailed demographics, medical and family history, medication history, health behaviors, physical activity, and anthropometric measures. The laboratory parameters of chemistry test. After the baseline visit, participants will return annually for follow-up visits and evaluation. The evaluating items of follow-up visits are similar to the baseline visit, and sample collection.
The principal clinical outcomes of the study can be broadly categorized as end stage renal disease and death. Death is further clarified as cardiac, infectious, renal, others, or unknown.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Xiangya Hospital | – | Other: No Intervention |
| The Second Xiangya Hospital | – | Other: No Intervention |
| The Third Xiangya Hospital | – | Other: No Intervention |
| Hunan Provincial People's Hospital | – | Other: No Intervention |
| Xiangtan Central Hospital | – | Other: No Intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study enrolled all the AAV patients that fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed
Key inclusion criteria (1 listed)
- Fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed consent
Key exclusion criteria (1 listed)
- Do not agree to sign informed consent
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 |
|---|---|---|
| No InterventionNo Intervention | Other | Hunan Provincial People's Hospital, The Second Xiangya Hospital, The Third Xiangya Hospital, Xiangtan Central Hospital, Xiangya Hospital |
Primary outcome
Death
Time frame: from date of baseline examination until the date of death from any cause, up to 60 months
death from any cause
End stage renal disease or significant loss of renal function
Time frame: from date of baseline examination until the date of first documented end stage renal disease or date of death from any cause, whichever came first, up to 60 months
start of chronic dialysis or renal transplantation or irreversible development of glomerular filtration rate <15 ml/minute per 1.73m(2)
2 secondary outcomes
Disease activity
Time frame: Five years
Adverse events
Time frame: Five 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 7 Apr 2022.
Related trials for ANCA Associated Vasculitis
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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.
Xiangcheng Xiao, doctor principal investigator
Xiangya Hospital of Central South University
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 Xiangya Hospital of Central South University at 1 site in China.
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 1 inclusion and 1 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 7 Apr 2022. 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 China. 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 Yong Zhong, doctor (+86073189753025, zhongyong121@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: from date of baseline examination until the date of death from any cause, up to 60 months). The study lists 2 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 7 Apr 2022.