Multicenter Cohort Study of AAV in Hunan of China

April 6, 2022 updated by: Xiangcheng Xiao, Xiangya Hospital of Central South University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study enrolled all the AAV patients that fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: from date of baseline examination until the date of death from any cause, up to 60 months
death from any cause
from date of baseline examination until the date of death from any cause, up to 60 months
End stage renal disease or significant loss of renal function
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity
Time Frame: Five years
assessed by the proportion of patients with severe flares
Five years
Adverse events
Time Frame: 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
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Collaborators

The Third Xiangya Hospital of Central South University
Hunan Provincial People's Hospital
Central South University
Xiangtan Central Hospital

Investigators

  • Principal Investigator: Xiangcheng Xiao, doctor, Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 16, 2022

Primary Completion (ANTICIPATED)

March 16, 2027

Study Completion (ANTICIPATED)

March 16, 2027

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (ACTUAL)

April 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202108374

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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