Clinical trial NCT05315141: Multicenter Cohort Study of AAV in Hunan of China
Official title: Multicenter Cohort Study of ANCA-associated Small Vasculitis in Hunan Province of China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ANCA Associated Vasculitis
Keywords: ANCA Associated Vasculitis
ESRD
Outcome
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Central South University
name: The Third Xiangya Hospital of Central South University
name: Hunan Provincial People's Hospital
name: Xiangtan Central Hospital
First posted: 2022-04-07
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study enrolled all the AAV patients that fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed

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.

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.

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

Primary outcomes:
measure: Death
timeFrame: from date of baseline examination until the date of death from any cause, up to 60 months
measure: End stage renal disease or significant loss of renal function
timeFrame: 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:
measure: Disease activity
timeFrame: Five years
measure: Adverse events
timeFrame: Five years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya hospital
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Xiangcheng Xiao, doctor
role: PRINCIPAL_INVESTIGATOR
References: