Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000328673
Ethics application status
Approved
Date submitted
20/03/2014
Date registered
26/03/2014
Date last updated
19/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetics of Oxypurinol in Patients on Dialysis
Scientific title
An observational study of oxypurinol pharmacokinetics in haemodialysis patients treated with allopurinol
Secondary ID [1] 284292 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 291437 0
Renal impairment 291438 0
Condition category
Condition code
Inflammatory and Immune System 291812 291812 0 0
Other inflammatory or immune system disorders
Renal and Urogenital 291813 291813 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with gout already receiving 100mg of allopurinol will be recruited from the haemodialysis unit. They will be observed over a 48 hour period that includes one dialysis cycle and two allopurinol dose intervals. On the first day, blood samples will be taken hourly prior to, during, and post-dialysis up until the first 100mg dose of allopurinol. The first blood sample will be taken directly prior to the start of dialysis and then will be taken hourly for 6 hours. The allopurinol will be taken directly following the last blood sample (6 hours after the start of dialysis). On the second day, a second 100mg dose of allopurinol will be given and eight blood samples will be taken at set intervals throughout the day. The first sample will be taken prior to the allopurinol dose, and the remaining samples will be taken 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, and 6 hours after the allopurinol dose. A final blood sample will be taken at 48 hours (post study commencement).
Intervention code [1] 289015 0
Not applicable
Comparator / control treatment
No control/comparison treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291727 0
Allopurinol and oxypurinol plasma area under the concentration time curves (trend across time in concentration). Laboratory analysis of the blood samples taken will be used to determine blood concentrations of allopurinol and oxypurinol, and area under the curve concentrations will be calculated using the trapezoidal method.
Timepoint [1] 291727 0
0 - 48 hours from dialysis commencement
Secondary outcome [1] 307359 0
Peak and trough concentrations at steady state will be assessed via laboratory analysis of the blood samples taken.
Timepoint [1] 307359 0
0 - 48 hours from dialysis commencement

Eligibility
Key inclusion criteria
Patients must be receiving haemodialysis, must be diagnosed with gout, and must be already receiving 100mg of allopurinol daily.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be reported as means and changes as mean difference. Allopurinol and oxypurinol concentration area under the curve (AUC) will be calculated using the trapezoidal method. Assuming a standard deviation of 30% in oxypurinol AUC, a sample of six subjects will allow estimation of the mean AUC with a margin of error of 32%

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2014
Actual
26/05/2014
Date of last participant enrolment
Anticipated
Actual
2/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 5908 0
New Zealand
State/province [1] 5908 0
Canterbury

Funding & Sponsors
Funding source category [1] 288923 0
Charities/Societies/Foundations
Name [1] 288923 0
Ross Bailey Nephrology Trust
Country [1] 288923 0
New Zealand
Primary sponsor type
Individual
Name
Professor Lisa Stamp
Address
Department of Medicine
University of Otago Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287615 0
None
Name [1] 287615 0
Address [1] 287615 0
Country [1] 287615 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290754 0
The University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 290754 0
Academic Committees Office
Ground Floor, Rm G22
Clocktower Building, Leith Street
University of Otago
North Dunedin
Dunedin 9016
Ethics committee country [1] 290754 0
New Zealand
Date submitted for ethics approval [1] 290754 0
31/03/2014
Approval date [1] 290754 0
14/04/2014
Ethics approval number [1] 290754 0

Summary
Brief summary
This observational study will track allopurinol and oxypurinol serum concentrations in haemodialysis patients with allopurinol-treated gout across a 48 hour period in order to determine the pharmacokinetics of oxypurinol (the active metabolite of allopurinol) in this particular population. The results will provide insight on the efficacy of current allopurinol dosing strategies in patients with gout on haemodialysis.
Trial website
Trial related presentations / publications
Wright DFB, Doogue MP, Barclay ML, Chapman PT, Cross NB, Irvine JH, Stamp LK. A population pharmacokinetic model to predict oxypurinol exposure in patients on haemodialysis. Eur J Clin Pharmacol 2016 In press
Public notes

Contacts
Principal investigator
Name 47066 0
Prof Lisa Stamp
Address 47066 0
Department of Medicine
University of Otago Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country 47066 0
New Zealand
Phone 47066 0
+64 3 364 0253
Fax 47066 0
+64 3 364 0935
Email 47066 0
[email protected]
Contact person for public queries
Name 47067 0
Prof Lisa Stamp
Address 47067 0
Department of Medicine
University of Otago Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country 47067 0
New Zealand
Phone 47067 0
+64 3 364 0253
Fax 47067 0
+64 3 364 0935
Email 47067 0
[email protected]
Contact person for scientific queries
Name 47068 0
Prof Lisa Stamp
Address 47068 0
Department of Medicine
University of Otago Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country 47068 0
New Zealand
Phone 47068 0
+64 3 364 0253
Fax 47068 0
+64 3 364 0935
Email 47068 0
[email protected]

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
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Documents added automatically
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