New Method for The Determination of Urinary Purine Concentration

• Register: EUCTR
• Last refreshed on: 10 October 2016
• Main ID: EUCTR2013-000975-33-IS
• Date of registration: 03/10/2013
• Prospective Registration: Yes
• Primary sponsor: Landspitali - The National University Hospital of Iceland
• Public title: New Method for The Determination of Urinary Purine Concentration
• Scientific title: Novel Assays for the Determination of Urinary 2,8-Dihydroxyadenine and Other Key Urinary Purine Metabolites - Rare Diseases Clinical Research Network Protocol Version 1
• Date of first enrolment: 19/11/2013
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000975-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Iceland

Contacts

• Name: Vidar Orn Edvardsson
• Affiliation: Landspitali - The National University Hospital of Iceland

• Name: Vidar Orn Edvardsson
• Affiliation: Landspitali - The National University Hospital of Iceland

Key inclusion & exclusion criteria

Inclusion criteria:
Participants will be eligible for inclusion if they meet the following criteria:
1. Are patients 18 year and older who are enrolled in the APRT Deficiency Registry of The Rare Kidney Stone Consortium.
2. Control subjects who are either i) heterozygotes for an APRT mutation or ii) healthy individuals without mutation in the APRT gene.
3. Consent to participation in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion criteria:
1. Patients do not want to interrupt drug treatment as requested.
2. No other exclusion criteria if inclusion criteria are met.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Adenine phosphoribosyltransferase deficiency

Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Intervention(s)

Trade Name: Adenuric
Pharmaceutical Form: Tablet

Trade Name: Allopurinol
Pharmaceutical Form: Tablet

Primary Outcome(s)

Main Objective: To conduct 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.

Secondary Objective: Not applicable.
1. To measure the daily urinary excretion of DHA and conventional urinary metabolic risk factors for stone formation in patients with dihydroxyadeninuria and correlate the results with clinical features of the disease.
2. To study the effect of dietary purine intake on urinary DHA excretion.

Timepoint(s) of evaluation of this end point: Days 7, 21 and 42.

Primary end point(s): Urinary 2,8-dihydroxyadenine excretion.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable.

Secondary end point(s): Not applicable.

Secondary ID(s)

RDCRN_RKSC_6412

Source(s) of Monetary Support

National Institutes of Health