Multicenter Cohort Study of AAV in Hunan of China

NCT ID: NCT05315141

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-16

Study Completion Date

2027-03-16

Brief Summary

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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

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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.

Conditions

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ANCA Associated Vasculitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Xiangya Hospital

No Intervention

Intervention Type OTHER

No Intervention

The Second Xiangya Hospital

No Intervention

Intervention Type OTHER

No Intervention

The Third Xiangya Hospital

No Intervention

Intervention Type OTHER

No Intervention

Hunan Provincial People's Hospital

No Intervention

Intervention Type OTHER

No Intervention

Xiangtan Central Hospital

No Intervention

Intervention Type OTHER

No Intervention

Interventions

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No Intervention

No Intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Do not agree to sign informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central South University

OTHER

Sponsor Role collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Hunan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Xiangtan Central Hospital

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Xiangcheng Xiao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiangcheng Xiao, doctor

Role: PRINCIPAL_INVESTIGATOR

Xiangya Hospital of Central South University

Locations

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Xiangya hospital

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yong Zhong, doctor

Role: CONTACT

+86073189753025

Ting Meng, doctor

Role: CONTACT

+86073184327431

Facility Contacts

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Yong Zhong, doctor

Role: primary

+86073189753025

Ting Meng, doctor

Role: backup

+86073184327431

Other Identifiers

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202108374

Identifier Type: -

Identifier Source: org_study_id

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