Multicenter Cohort Study of AAV in Hunan of China
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Xiangya Hospital
|
Other: No Intervention
No Intervention
|
| The Second Xiangya Hospital
|
Other: No Intervention
No Intervention
|
| The Third Xiangya Hospital
|
Other: No Intervention
No Intervention
|
| Hunan Provincial People's Hospital
|
Other: No Intervention
No Intervention
|
| Xiangtan Central Hospital
|
Other: No Intervention
No Intervention
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xiangya hospital | Changsha | Hunan | China | 410008 |
Sponsors and Collaborators
- Xiangya Hospital of Central South University
- Central South University
- The Third Xiangya Hospital of Central South University
- Hunan Provincial People's Hospital
- Xiangtan Central Hospital
Investigators
- Principal Investigator: Xiangcheng Xiao, doctor, Xiangya Hospital of Central South University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202108374