Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion

NCT02752633 | Completed Phase 4 Results DMC

• 3 other identifiers: RDCRN Protocol #64122013-000975-33U54DK083908
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenine Phosphoribosyltransferase Deficiency

Keywords

Xanthine dehydrogenase inhibitor treatment, pharmacotherapy

Outcome Measures

Primary Outcomes (1)

• Urinary 2,8-dihydroxyadenine Excretion

  7, 21 and 42 days

Study Arms (1)

Study subjects

EXPERIMENTAL

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.

Drug: Allopurinol; Drug: Febuxostat

Interventions

Allopurinol DRUG

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.

Also known as: Apurin, ATC Code M04AA01

Study subjects

Febuxostat DRUG

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.

Also known as: Uloric, ATC Code M04AA03

Study subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients 18 year and older who are enrolled in the APRT Deficiency Registry of The Rare Kidney Stone Consortium.

Sponsors & Collaborators

• Landspitali University Hospital: lead
• Mayo Clinic: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Landspitali - The National University Hospital of Iceland

Reykjavik, 101, Iceland

Location

Related Publications (1)

• Runolfsdottir HL, Palsson R, Agustsdottir IM, Indridason OS, Edvardsson VO. Kidney Disease in Adenine Phosphoribosyltransferase Deficiency. Am J Kidney Dis. 2016 Mar;67(3):431-8. doi: 10.1053/j.ajkd.2015.10.023. Epub 2015 Dec 25.

  PMID: 26724837 RESULT

Related Links

• Official website of the Rare Kidney Stone Consortium

MeSH Terms

Conditions

Adenine phosphoribosyltransferase deficiency

Interventions

Allopurinol; Febuxostat

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Vidar Orn Edvardsson
• Organization: Landspitali - The National University Hospital of Iceland

vidare@landspitali.is

+3545431000

Study Officials

• Vidar O Edvardsson, MD

  Landspitali - The National University Hospital of Iceland, Reykjavik

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 27, 2016
• Study Start: May 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 9, 2024
• Results First Posted: December 27, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share

Locations

IC (1)