Multicenter Cohort Study of AAV in Hunan of China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention.
- Who it may be relevant to
- Registry conditions: ANCA Associated Vasculitis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicenter Cohort Study of ANCA-associated Small Vasculitis in Hunan Province of China
Overview
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.
Interventions
- Other No Intervention
No Intervention
Primary outcome measures
- Death [Time frame: 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 [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]
Secondary outcome measures (2)
- Disease activity [Time frame: Five years]
- Adverse events [Time frame: Five years]
Eligibility criteria
Inclusion criteria
- Fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed consent
Exclusion criteria
- Do not agree to sign informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xiangya hospital — Changsha
Identifiers
NCT: NCT05315141 · 202108374