Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001302549
Ethics application status
Approved
Date submitted
25/11/2015
Date registered
30/11/2015
Date last updated
16/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of genetic variants on inosine-induced hyperuricaemia
Scientific title
The influence of genetic variants on inosine-induced hyperuricaemia in healthy adult volunteers
Secondary ID [1] 287990 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 296871 0
Hyperuricaemia 296887 0
Condition category
Condition code
Musculoskeletal 297102 297102 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 297103 297103 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral inosine 1.5g will be administered under direct observation on a single occasion to all participants. Participants will then be observed for three hours.
Intervention code [1] 293332 0
Treatment: Drugs
Comparator / control treatment
Comparison between individuals possessing at least one protective allele at the SLC2A9 SNP rs11942223 and those without the protective allele
Comparison between individuals possessing at least one ABCG2 141K variant and those without the 141K variant.
These alleles are determined by testing a blood sample.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296711 0
Change in serum urate concentration following a inosine challenge (blood test)
Timepoint [1] 296711 0
15 minutes, 30 minutes, 60 minutes, 120 minutes, and 180 minutes after ingestion
Secondary outcome [1] 319158 0
Change in fractional excretion of urate to 3 hours following a inosine challenge (blood and urine test)
Timepoint [1] 319158 0
Blood and urine tests will be taken at the following time points: 30 minutes, 60 minutes, 120 minutes, and 180 minutes after ingestion

Eligibility
Key inclusion criteria
a. Able to provide written informed consent
b. eGFR>60 mL/min/1.73 m2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a. History of gout
b. History of kidney stones
c. History of diabetes mellitus
d. Diuretic use
e. Urine pH less than or equal to 5.0 (risk factor for uric acid urolithiasis)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2016
Actual
3/02/2016
Date of last participant enrolment
Anticipated
Actual
9/08/2016
Date of last data collection
Anticipated
Actual
31/08/2016
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 7368 0
New Zealand
State/province [1] 7368 0
Auckland

Funding & Sponsors
Funding source category [1] 292454 0
Government body
Name [1] 292454 0
Health Research Council
Country [1] 292454 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85 Park Rd
Grafton Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 291152 0
None
Name [1] 291152 0
NA
Address [1] 291152 0
NA
Country [1] 291152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293914 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 293914 0
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 293914 0
New Zealand
Date submitted for ethics approval [1] 293914 0
04/12/2015
Approval date [1] 293914 0
21/12/2015
Ethics approval number [1] 293914 0

Summary
Brief summary
This intervention study is designed to to examine the influence of genetic variation on inosine-induced hyperuricaemia. The primary endpoint is change in serum urate over 180 minutes after inosine ingestion. Key secondary and exploratory endpoints are change in fractional excretion of urate. The key genes of interest are SLC2A9 (GLUT9) and ABCG2. However, other genes associated with purine synthesis and urate transport may also be examined in later exploratory analyses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61810 0
Prof Nicola Dalbeth
Address 61810 0
Room 502-201D Bone and Joint Research Group Department of Medicine Faculty of Medical and Health Sciences University of Auckland 85 Park Rd, Grafton, Auckland 1023
Country 61810 0
New Zealand
Phone 61810 0
+64 (0) 9 3737999 x82568
Fax 61810 0
+64 (0) 9 3737677
Email 61810 0
n.dalbeth@auckland.ac.nz
Contact person for public queries
Name 61811 0
Dr Anne Horne
Address 61811 0
Bone and Joint Research Group
Department of Medicine
Faculty of Medical and Health Sciences
University of Auckland
85 Park Rd, Grafton, Auckland 1023
Country 61811 0
New Zealand
Phone 61811 0
+64 (0) 9 3737999 x89787
Fax 61811 0
+64 (0) 9 3737677
Email 61811 0
a.horne@auckland.ac.nz
Contact person for scientific queries
Name 61812 0
Prof Nicola Dalbeth
Address 61812 0
Bone and Joint Research Group
Department of Medicine
Faculty of Medical and Health Sciences
University of Auckland
85 Park Rd, Grafton, Auckland 1023
Country 61812 0
New Zealand
Phone 61812 0
+64 (0) 9 3737999 x82568
Fax 61812 0
+64 (0) 9 3737677
Email 61812 0
n.dalbeth@auckland.ac.nz

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseEffect of body mass index on serum urate and renal uric acid handling responses to an oral inosine load: experimental intervention study in healthy volunteers.2020https://dx.doi.org/10.1186/s13075-020-02357-y
N.B. These documents automatically identified may not have been verified by the study sponsor.