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Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05315141
Study type Observational [Patient Registry]
Source Xiangya Hospital of Central South University
Contact Yong Zhong, doctor
Phone +86073189753025
Email zhongyong121@163.com
Status Recruiting
Phase
Start date March 16, 2022
Completion date March 16, 2027

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