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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 April 2024 |
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Main ID: |
NCT02752633 |
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Date of registration:
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20/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion
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Scientific title:
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A Novel Assay for the Determination of Urinary 2,8-Dihydroxyadenine and Other Key Urinary Purine Metabolites: Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion in APRT Deficient Patients |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02752633 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Iceland
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Contacts
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Name:
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Vidar O Edvardsson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Landspitali - The National University Hospital of Iceland, Reykjavik |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients 18 year and older who are enrolled in the APRT Deficiency Registry of The
Rare Kidney Stone Consortium.
Exclusion Criteria:
- Patients do not want to interrupt drug (allopurinol) treatment for a total of two
weeks as requested in protocol. No other exclusion criteria if inclusion criteria are
met.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Adenine Phosphoribosyltransferase Deficiency
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Intervention(s)
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Drug: Febuxostat
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Drug: Allopurinol
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Primary Outcome(s)
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Urinary 2,8-dihydroxyadenine Excretion
[Time Frame: 7, 21 and 42 days]
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Secondary ID(s)
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U54DK083908
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2013-000975-33
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RDCRN Protocol #6412
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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