Actively Recruiting

All Genders
ID05315141

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

Led by Xiangya Hospital of Central South University · Updated on 2022-04-07

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

X

Xiangya Hospital of Central South University

Lead Sponsor

C

Central South University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the incidence and progression of Anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV) and its link to serious outcomes like end stage renal disease (ESRD) and death. This multicenter prospective cohort study will enroll about 500 patients with AAV from Hunan province, China, to better understand the disease over time. Participants will have a baseline visit where demographic information, medical and family history, medication use, lifestyle factors, physical activity, and body measurements are collected. Laboratory tests and imaging exams will also be performed. After the initial visit, participants will be followed annually for at least 5 years, with similar evaluations and sample collections at each follow-up. During the study, researchers will monitor major outcomes including ESRD and death, classified by causes such as cardiac, infectious, or renal reasons. Data collected at baseline and follow-ups will include clinical and laboratory information to assess disease activity and adverse events over time. The total participation duration is planned to be five years or until death, starting renal replacement therapy, or dropout.

CONDITIONS

Brief Title

Multicenter Cohort Study of AAV in Hunan of China

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fulfill 2012 criteria of ANCA associated vasculitis
  • Agree to sign informed consent
Not Eligible

You will not qualify if you...

  • Do not agree to sign informed consent

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Baseline Evaluation

Duration - 1 day

Participants undergo a baseline visit to collect detailed demographics, medical and family history, medication history, health behaviors, physical activity, anthropometric measures, and laboratory parameters.

1 baseline visit (in-person)

Long-term Monitoring

Duration - At least 5 years

Participants are followed annually for at least 5 years to evaluate clinical outcomes including disease activity, adverse events, and progression to end stage renal disease or death. Follow-up assessments include similar evaluations and sample collections as the baseline visit.

Annual follow-up visits

Trial Site Locations

Total: 1 location

1

Xiangya hospital

Changsha, Hunan, China, 410008

Actively Recruiting

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Research Team

Y

Yong Zhong, doctor

T

Ting Meng, doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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