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Trial record 1 of 1 for:    "Adenine Phosphoribosyltransferase Deficiency" | "Febuxostat"
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Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion

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ClinicalTrials.gov Identifier: NCT02752633
Recruitment Status : Completed
First Posted : April 27, 2016
Results First Posted : December 27, 2017
Last Update Posted : December 27, 2017
Sponsor:
Collaborators:
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Landspitali University Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adenine Phosphoribosyltransferase Deficiency
Interventions Drug: Allopurinol
Drug: Febuxostat
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Allopurinol/Febuxostat Treatment
Hide Arm/Group Description This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
Period Title: Overall Study
Started 9
Completed 8
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Allopurinol/Febuxostat Treatment
Hide Arm/Group Description This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  88.9%
>=65 years
1
  11.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
54
(28 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
5
  55.6%
Male
4
  44.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
9
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Iceland Number Analyzed 9 participants
9
1.Primary Outcome
Title Urinary 2,8-dihydroxyadenine Excretion
Hide Description [Not Specified]
Time Frame 0, 14 and 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allopurinol/Febuxostat Treatment
Hide Arm/Group Description:

Following a 7 day washout period all patients receive allopurinol (400 mg/day) as a single daily dose for 2 weeks. Following another 7 day washout period all participants receive febuxostat, 80 mg/day as a single daily dose, for 2 weeks.

Allopurinol: This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.

Febuxostat: This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.

Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: mg/24-h
Baseline
116
(75 to 289)
On allopurinol treatment
45
(13 to 112)
On febuxostat treatment
13
(10 to 13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allopurinol/Febuxostat Treatment
Comments Data are presented as the urinary DHA excretion (mg/24 hr) and as the DHA-to-creatinine ratio (mg/mmol) in first morning void urine samples. Data are presented as a median (range). Differences in the median urinary DHA excretion and the urinary DHA-to-creatinine ratio between periods off pharmacotherapy and on the two study drugs, febuxostat and allopurinol, were assessed using the Wilcoxon signed rank test.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Throughout the study, 42 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Allopurinol/Febuxostat Treatment
Hide Arm/Group Description This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
All-Cause Mortality
Allopurinol/Febuxostat Treatment
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Allopurinol/Febuxostat Treatment
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Allopurinol/Febuxostat Treatment
Affected / at Risk (%)
Total   0/9 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Vidar Orn Edvardsson
Organization: Landspitali - The National University Hospital of Iceland
Phone: +3545431000 ext 3452
Responsible Party: Landspitali University Hospital
ClinicalTrials.gov Identifier: NCT02752633     History of Changes
Other Study ID Numbers: RDCRN Protocol #6412
2013-000975-33 ( EudraCT Number )
U54DK083908 ( U.S. NIH Grant/Contract )
First Submitted: April 20, 2016
First Posted: April 27, 2016
Results First Submitted: October 12, 2017
Results First Posted: December 27, 2017
Last Update Posted: December 27, 2017