Multicenter Cohort Study of AAV in Hunan of China

Recruiting

• Conditions: ANCA Associated Vasculitis
• Interventions: Other: No Intervention

• Registration Number: NCT05315141
• Lead Sponsor: Xiangya Hospital of Central South University

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.

Study Timeline

• Study Start: 2022-03-16
• Study First Submitted: 2022-03-16
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-06
• Last Update Submitted: 2022-04-06
• Study First Posted: 2022-04-07
• Last Update Posted: 2022-04-07
• Primary Completion: 2027-03-16
• Study Completion: 2027-03-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed consent

Exclusion Criteria

• Do not agree to sign informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The Third Xiangya Hospital	No Intervention	-
Hunan Provincial People's Hospital	No Intervention	-
Xiangtan Central Hospital	No Intervention	-
Xiangya Hospital	No Intervention	-
The Second Xiangya Hospital	No Intervention	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Disease activity	Five years	assessed by the proportion of patients with severe flares

Trial Locations

Locations (1)

Xiangya hospital; 🇨🇳 Changsha, Hunan, China