ANCA Associated Vasculitis
Conditions
Keywords
ANCA Associated Vasculitis, ESRD, Outcome
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.
Interventions
OTHERNo Intervention
No Intervention
Sponsors
Central South University
The Third Xiangya Hospital of Central South University
Hunan Provincial People's Hospital
Xiangtan Central Hospital
Xiangya Hospital of Central South University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed consent
Exclusion criteria
* Do not agree to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity | Five years | assessed by the proportion of patients with severe flares |
| Adverse events | Five years | a. deaths (from all causes); b. grade 3 or higher infections; c. malignant conditions; d. venous thromboembolic events; e. cardiovascular events; f. hospitalizations |
Countries
China
Contacts
Primary ContactYong Zhong, doctor
Backup ContactTing Meng, doctor
Outcome results
None listed