Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000486123p
Ethics application status
Submitted, not yet approved
Date submitted
23/02/2019
Date registered
25/03/2019
Date last updated
25/03/2019
Date data sharing statement initially provided
25/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Vasculitis and Diabetes study.
A pilot randomised controlled trial to determine the feasibility, tolerability and efficacy of metformin in patients with anti-neutrophil cytoplasmic antibody positive vasculitis.
Scientific title
The Vasculitis and Diabetes study
An open labelled, pilot randomised controlled trial to determine the feasibility, tolerability and efficacy of metformin in patients with anti-neutrophil cytoplasmic antibody (ANCA) positive vasculitis.
Secondary ID [1] 297514 0
None
Universal Trial Number (UTN)
U1111-1229-1378
Trial acronym
VascDiab
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 311716 0
Anti-neutrophil cytoplasmic antibody associated vasculitis 311717 0
Condition category
Condition code
Metabolic and Endocrine 310336 310336 0 0
Diabetes
Inflammatory and Immune System 310337 310337 0 0
Autoimmune diseases
Renal and Urogenital 310358 310358 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Metformin
Patients in addition to standard care, will receive metformin 500mg tablet once daily oral if their eGFR is 15-29 ml/min/1.73m2 or metformin 500mg tablet twice daily oral if their eGFR is equal or greater than 30 ml/min/1.73m2. This will continue for 12 months.
Metformin concentration will be assessed at 3, 6, 9 and 12 months.
Intervention code [1] 313752 0
Treatment: Drugs
Comparator / control treatment
Control group - patients with anti-neutrophil cytoplasmic antibody (ANCA) positive vasculitis on immunosuppressive therapy (immunosuppression will be standard of care at each treating centre).
Control group
Active

Outcomes
Primary outcome [1] 319215 0
Primary outcomes

1.) Feasibility of recruitment
Feasibility of recruitment will be assessed by the ratio of the number of enrolled patients to the number of patients screened.
Timepoint [1] 319215 0
12 months.
Primary outcome [2] 319216 0
2.) Tolerability of metformin
Tolerability of metformin will be assessed using the Gastrointestinal Symptom Rating Scale, a tool that has been validated to assess symptoms in gastrointestinal disorders such as gastro-oesophageal reflux disease and irritable bowel syndrome at baseline, 3, 6, 9 and 12 months post-randomisation.
Timepoint [2] 319216 0
3, 6, 9 and 12 months
Primary outcome [3] 319217 0
3.) Efficacy of metformin
Efficacy of metformin will be assessed by serum HbA1C at baseline, 3, 6, 9 and 12 months post-enrollment. Change in serum HbA1c will be assessed at these timepoints from baseline.
Timepoint [3] 319217 0
3, 6, 9 and 12 months
Secondary outcome [1] 367335 0
Weight will be measured in kg. Change in body weight, the difference between baseline and at 12 months. Weight will be measure by a weighing scale.
Timepoint [1] 367335 0
12 months
Secondary outcome [2] 367385 0
Infections as assessed and documented by the treating Physician - Number/type/duration.
Timepoint [2] 367385 0
12 months
Secondary outcome [3] 367386 0
All adverse events e.g. admission to hospital for > 1 day. This be using discharge summaries.

Timepoint [3] 367386 0
12 months
Secondary outcome [4] 367387 0
Total cholesterol - (serum)
Timepoint [4] 367387 0
@ baseline, 3, 6, 9 and 12 months

Eligibility
Key inclusion criteria
Inclusion criteria will include the following: age >18 years, non-diabetic patient a clinical diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis, consistent with Chapel-Hill Consensus Conference definitions [Jenette, 2013], willing and able to participate in all trial investigations for the duration of trial follow-up and ability to provide a written informed consent.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include the following: known diabetes mellitus at the time of diagnosis of ANCA-associated vasculitis (whether on anti-diabetic medications or not), history of anti-diabetic therapy (oral or insulin), estimated glomerular filtration rate (eGFR) by the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) < 20ml per minute per 1..73 metres squared BSA (body surface area), unable to consent, pregnancy or breast feeding, current alcohol or other substance abuse and any major illness or comorbidity that may result in death in 12 months as assessed by the treating physician.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Open-labelled/Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The Vasculitis and Diabetes (VascDiab) study is a randomised, unblinded, parallel-group, multi-centre, pilot trial.
Phase
Phase 2 / Phase 3
Type of endpoint/s
Statistical methods / analysis
Feasibility of recruitment, will be reported as a ratio of the number of randomised patients to the number of patients screened at the conclusion of the study.

Tolerability of metformin, will be reported as Gastrointestinal Symptom Rating Scale at 3, 6, 9 and 12 months.

Efficacy of metformin, will be reported by measuring HbA1c 3, 6, 9 and 12 months post-randomisation and compared between the two groups using an ANCOVA adjusted for HbA1c at baseline.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2020
Actual
Date of last participant enrolment
Anticipated
1/02/2021
Actual
Date of last data collection
Anticipated
1/02/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 21306 0
New Zealand
State/province [1] 21306 0

Funding & Sponsors
Funding source category [1] 302072 0
Hospital
Name [1] 302072 0
North Shore Hospital, Waitemata District Health Board
Country [1] 302072 0
New Zealand
Primary sponsor type
Hospital
Name
North Shore Hospital, Waitemata District Health Board
Address
North Shore Hospital
122 Shakespeare Road
Takapuna
Auckland 0622
New Zealand
Country
New Zealand
Secondary sponsor category [1] 301888 0
None
Name [1] 301888 0
Address [1] 301888 0
Country [1] 301888 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302753 0
Health and Disability Ethics Committee (New Zeland)
Ethics committee address [1] 302753 0
Ethics committee country [1] 302753 0
New Zealand
Date submitted for ethics approval [1] 302753 0
22/03/2019
Approval date [1] 302753 0
Ethics approval number [1] 302753 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91278 0
Dr Janak de Zoysa
Address 91278 0
Renal Service
North Shore Hospital
Waitemata District Health Board
122 Shakespeare Road
Takapuna
Auckland 0622
New Zealand
Country 91278 0
New Zealand
Phone 91278 0
+64 9 486 8900
Fax 91278 0
+64 9 442 3218
Email 91278 0
[email protected]
Contact person for public queries
Name 91279 0
Janak de Zoysa
Address 91279 0
Renal Service
North Shore Hospital
Waitemata District Health Board
122 Shakespeare Road
Takapuna
Auckland 0622
New Zealand
Country 91279 0
New Zealand
Phone 91279 0
+64 9 486 8900
Fax 91279 0
+64 9 442 3218
Email 91279 0
[email protected]
Contact person for scientific queries
Name 91280 0
Janak de Zoysa
Address 91280 0
Renal Service
North Shore Hospital
Waitemata District Health Board
122 Shakespeare Road
Takapuna
Auckland 0622
New Zealand
Country 91280 0
New Zealand
Phone 91280 0
+64 9 486 8900
Fax 91280 0
+64 9 442 3218
Email 91280 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified individual participant data collected by the trial will be shared.
When will data be available (start and end dates)?
Beginning2 years and ending 5 years following main results publication
Available to whom?
Data will be provided to researchers who provide a methodologically sound proposal on a case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
For individual patient data meta-analyses or another appropriate analysis.
How or where can data be obtained?
Access to data will be subject to approvals by Principal Investigator. There will be a requirement to sign a data access agreement.


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.