Phase 4
N=9
Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion
Adenine Phosphoribosyltransferase Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT02752633 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Urinary 2,8-dihydroxyadenine Excretion — 116; 45; 13 mg/24-h — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Allopurinol (Drug); Febuxostat (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Landspitali University Hospital
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary 2,8-dihydroxyadenine Excretion |
116; 45; 13 | <.05 sig |
Summary
This exploratory pilot study was an open-label, crossover, single-center and non-randomized clinical trial designed to compare the effect of the standardly employed doses of allopurinol (400 mg/day) and febuxostat (80 mg/day) on the urinary 2,8-dihydroxyadenine (DHA) excretion in patients with adenine phosphoribosyltransferase (APRT) deficiency.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02752633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.