Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000012774
Ethics application status
Approved
Date submitted
19/10/2021
Date registered
11/01/2022
Date last updated
16/12/2022
Date data sharing statement initially provided
11/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 305590 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This record is a sub-study of ACTRN12619001030167

Health condition
Health condition(s) or problem(s) studied:
ANCA Vasculitis 324014 0
Condition category
Condition code
Inflammatory and Immune System 321519 321519 0 0
Autoimmune diseases
Renal and Urogenital 321889 321889 0 0
Other renal and urogenital disorders
Cardiovascular 321890 321890 0 0
Diseases of the vasculature and circulation including the lymphatic system
Respiratory 321891 321891 0 0
Other respiratory disorders / diseases
Skin 321892 321892 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Years
Description of intervention(s) / exposure
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
Intervention code [1] 321988 0
Not applicable
Comparator / control treatment
No control group.

The same treatment will be given to all patients.
Some will relapse despite this treatment.
How the ANCA levels changed prior will be compared between patients who relapsed and those who did not.
Control group
Active

Outcomes
Primary outcome [1] 329286 0
Relapse rate in patients with two-fold ANCA rise compared to those without an ANCA rise.

Method: Audit of study records
Timepoint [1] 329286 0
Monitoring post induction 3 monthly for at least 3 years
Primary outcome [2] 329287 0
Relapse rate in patients with four-fold ANCA rise compared to patients without ANCA rise

Method: Audit of study records
Timepoint [2] 329287 0
Monitoring post induction 3 monthly for at least 3 years
Primary outcome [3] 329642 0
Identify if initial induction therapy (rituximab vs cyclophosphamide) impacts the performance of these assays in predicting relapse.

Method: Audit of study records
Timepoint [3] 329642 0
monitoring 3 monthly for at least 3 years post induction
Secondary outcome [1] 402024 0
Nil
Timepoint [1] 402024 0
N/A

Eligibility
Key inclusion criteria
Patients with ANCA vasculitis based on compatible serology, radiology, histology and/or biochemistry.

Participants need to have been enrolled into the Queensland Renal Biopsy Registry
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ANCA negative vasculitis

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
109
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 309955 0
Government body
Name [1] 309955 0
SEC, Pathology Queensland
Country [1] 309955 0
Australia
Primary sponsor type
Individual
Name
Dr Dwarakanathan Ranganathan
Address
Royal Brisbane and Womens Hospital, Butterfield St, Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 311309 0
None
Name [1] 311309 0
Address [1] 311309 0
Country [1] 311309 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309670 0
Royal Brisbane & Women’s Hospital Human Research Ethics Committee
Ethics committee address [1] 309670 0
Royal Brisbane & Women’s Hospital
Executive Suites, Lower Ground Floor
Dr James Mayne Building
Butterfield Street, Herston Qld 4029
Ethics committee country [1] 309670 0
Australia
Date submitted for ethics approval [1] 309670 0
29/05/2020
Approval date [1] 309670 0
16/06/2020
Ethics approval number [1] 309670 0

Summary
Brief 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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114978 0
A/Prof Dwarakanathan Ranganathan
Address 114978 0
Royal Brisbane and Women's Hospital, Butterfield St, Herston QLD 4029
Country 114978 0
Australia
Phone 114978 0
+61 412246608
Fax 114978 0
Email 114978 0
dwarakanathan.ranganathan@health.qld.gov.au
Contact person for public queries
Name 114979 0
A/Prof Dwarakanathan Ranganathan
Address 114979 0
Royal Brisbane and Women's Hospital, Butterfield St, Herston, QLD 4029
Country 114979 0
Australia
Phone 114979 0
+61 412246608
Fax 114979 0
Email 114979 0
dwarakanathan.ranganathan@health.qld.gov.au
Contact person for scientific queries
Name 114980 0
A/Prof Dwarakanathan Ranganathan
Address 114980 0
Royal Brisbane and Women's Hospital, Butterfield St, Herston QLD 4029
Country 114980 0
Australia
Phone 114980 0
+61 412246608
Fax 114980 0
Email 114980 0
dwarakanathan.ranganathan@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.