Multicenter Cohort Study of AAV in Hunan of China
Multicenter Cohort Study of ANCA-associated Small Vasculitis in Hunan Province of China
1 other identifier
observational
500
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
1 active site
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
March 16, 2022
CompletedStudy Start
First participant enrolled
March 16, 2022
CompletedFirst Posted
Study publicly available on registry
April 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 16, 2027
April 7, 2022
April 1, 2022
5 years
March 16, 2022
April 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Death
death from any cause
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)
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
Five years
Adverse events
Five years
Study Arms (5)
Xiangya Hospital
The Second Xiangya Hospital
The Third Xiangya Hospital
Hunan Provincial People's Hospital
Xiangtan Central Hospital
Interventions
No Intervention
Eligibility Criteria
The study enrolled all the AAV patients that fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed
You may qualify if:
- Fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed consent
You may not qualify if:
- Do not agree to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiangya Hospital of Central South Universitylead
- Central South Universitycollaborator
- The Third Xiangya Hospital of Central South Universitycollaborator
- Hunan Provincial People's Hospitalcollaborator
- Xiangtan Central Hospitalcollaborator
Study Sites (1)
Xiangya hospital
Changsha, Hunan, 410008, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiangcheng Xiao, doctor
Xiangya Hospital of Central South University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 16, 2022
First Posted
April 7, 2022
Study Start
March 16, 2022
Primary Completion (Estimated)
March 16, 2027
Study Completion (Estimated)
March 16, 2027
Last Updated
April 7, 2022
Record last verified: 2022-04