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NCT Number: NCT05315141

Multicenter Cohort Study of AAV in Hunan 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.

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Key information

Conditions

ANCA Associated Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Urogenital Diseases Urologic Diseases Vascular Diseases Vasculitis

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Do not agree to sign informed consent

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

  1. Death

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

    death from any cause

  2. 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)

Secondary outcomes

  1. Disease activity

    Time frame: Five years

    assessed by the proportion of patients with severe flares

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ting Meng, doctor

CONTACT

[email protected]

+86073184327431

Yong Zhong, doctor

CONTACT

[email protected]

+86073189753025

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2022
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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