Clinical trial

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

Name

RDCRN Protocol #6412

Description

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.

Trial arms

Trial start

2013-05-01

Estimated PCD

2015-05-01

Trial end

2015-05-01

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Study subjects

Other names:

Apurin, ATC Code M04AA01

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.

Arms:

Study subjects

Other names:

Uloric, ATC Code M04AA03

Size

Primary endpoint

Urinary 2,8-dihydroxyadenine Excretion

7, 21 and 42 days

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 9, 'type': 'ACTUAL'}}

Updated at

2024-04-09

1 organization

1 product

1 drug

1 indication

Organization

Landspitali University Hospital

Drug

Allopurinol

Indication

Adenine Phosphoribosyltransferase Deficiency

Product

Febuxostat