RecruitingACTRN12622000012774

Queensland Renal Biopsy Registry Sub Study: Multi-centre prospective observational cohort study investigating association between anti-neutrophil cytoplasmic antibodies (ANCA) results and relapse of ANCA associated vasculitis

Multi-centre prospective observational cohort study investigating association between anti-neutrophil cytoplasmic antibodies (ANCA) results and relapse of anti-neutrophil cytoplasmic antibodies (ANCA) associated vasculitis


Sponsor

Dr Dwarakanathan Ranganathan

Enrollment

109 participants

Start Date

May 13, 2021

Study Type

Observational

Conditions

Summary

This prospective study will monitor ANCA levels in patients with ANCA vasculitis. The purpose of this study is to Identify if ANCA rises are associated with relapse of ANCA vasculitis. Study hypothesis: two and four-fold ANCA rises will precede clinical relapses within the prior 6 months


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

ANCA-associated vasculitis is an autoimmune condition where the immune system mistakenly attacks small blood vessels throughout the body — particularly in the kidneys and lungs. It can go into remission, but relapses are common and can cause serious organ damage. Blood tests measuring ANCA (anti-neutrophil cytoplasmic antibodies) levels are already used to help diagnose this condition, but it's unclear whether a rise in ANCA levels reliably predicts an upcoming relapse. This study will regularly monitor ANCA levels in patients with vasculitis over time to determine whether a two- to four-fold rise in ANCA levels consistently precedes a clinical flare by up to 6 months. If this proves true, doctors could use ANCA monitoring to intervene earlier and potentially prevent organ damage from relapses. You may be eligible if you have been diagnosed with ANCA-associated vasculitis based on laboratory, imaging, or biopsy results, and are already enrolled in the Queensland Renal Biopsy Registry. Those who test ANCA-negative would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

3 monthly assessments for at least 3 years. Monitoring association between ANCA levels and disease activity / relapse. - No alteration to patient standard medical care - However, patient medical

3 monthly assessments for at least 3 years. Monitoring association between ANCA levels and disease activity / relapse. - No alteration to patient standard medical care - However, patient medical records will be accessed - long-term (many years) 3 monthly follow up will be required for disease management irrespective of enrolment in trial


Locations(1)

QLD, Australia

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ACTRN12622000012774


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