Multicenter Cohort Study of AAV in Hunan of China

ANCA Associated Vasculitis Clinical Trial

Official title:

Multicenter Cohort Study of ANCA-associated Small Vasculitis in Hunan Province of China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05315141
• Other study ID #: 202108374
• Status: Recruiting
• Start date: March 16, 2022
• Est. completion date: March 16, 2027

Study information

• Verified date: April 2022
• Source: Xiangya Hospital of Central South University
• Contact: Yong Zhong, doctor
• Phone: +86073189753025
• Email: zhongyong121[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 16, 2027
• Est. primary completion date: March 16, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Do not agree to sign informed consent

Related Conditions & MeSH terms

• ANCA Associated Vasculitis
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Vasculitis

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
China	Xiangya hospital	Changsha	Hunan

Sponsors (5)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University	Central South University, Hunan Provincial People's Hospital, The Third Xiangya Hospital of Central South University, Xiangtan Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	death from any cause	from date of baseline examination until the date of death from any cause, up to 60 months
Primary	End stage renal disease or significant loss of renal function	start of chronic dialysis or renal transplantation or irreversible development of glomerular filtration rate <15 ml/minute per 1.73m(2)	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	Disease activity	assessed by the proportion of patients with severe flares	Five years
Secondary	Adverse events	a. deaths (from all causes); b. grade 3 or higher infections; c. malignant conditions; d. venous thromboembolic events; e. cardiovascular events; f. hospitalizations	Five years