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Multicenter Cohort Study of AAV in Hunan of China

ConditionANCA Associated Vasculitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorXiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Do not agree to sign informed consent

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention

    Other intervention

    No Intervention

Treatment groups

500 Participants
are divided into 5 treatment groups
Group A: Xiangya Hospital1 intervention
Group B: The Second Xiangya Hospital1 intervention
Group C: The Third Xiangya Hospital1 intervention
Group D: Hunan Provincial People's Hospital1 intervention
Group E: Xiangtan Central Hospital1 intervention

Trial outcomes

Primary outcomes

1

Death

death from any cause

Time frame
from date of baseline examination until the date of death from any cause, up to 60 months
2

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)

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

Secondary outcomes

1

Disease activity

assessed by the proportion of patients with severe flares

Time frame
Five years
2

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

Time frame
Five years

Other outcomes

Sponsors and contacts

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Xiangya Hospital of Central South University

Lead sponsor

Central South University

Collaborator

The Third Xiangya Hospital of Central South University

Collaborator

Hunan Provincial People's Hospital

Collaborator

Xiangtan Central Hospital

Collaborator

Source ClinicalTrials.gov
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