Allopurinol and Febuxostat Treatment in Patients with Adenine Phosphoribosyltransferase Deficiency: A Clinical Trial

Comparison of the Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion and Plasma Levels in Patients with Adenine Phosphoribosyltransferase Deficiency: A Clinical Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002185-40-IS

Enrollment

Registered

2024-07-08

Start date

2022-10-06

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenine phosphoribosyltransferase deficiency

Interventions

Trade Name: Uloric Pharmaceutical Form: Tablet Trade Name: Allopurinol Alvogen Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects =18 years of age with confirmed (genetic testing or APRT enzyme activity measurements) adenine phosphoribosyltransferase (APRT) deficiency who are participating in the APRT Deficiency Registry of the Rare Kidney Stone Consortium are eligible for 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 8 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect of allopurinol in the daily dose of 400 mg and 800 mg, and febuxostat 40 mg and 80 mg daily on the urinary excretion and plasma levels of 2,8-dihydroxyadenine in patients with adenine phosphoribosyltransferase deficiency.;Secondary Objective: Not applicable.;Primary end point(s): 1. Urinary 2,8-dihydroxyadenine excretion. 2. Plasma 2,8-dihydroxyadenine levels.;Timepoint(s) of evaluation of this end point: At trial dates 28, 56, 84, 112, 140 and 168.	—

Measure

Time frame

Main Objective: To compare the effect of allopurinol in the daily dose of 400 mg and 800 mg, and febuxostat 40 mg and 80 mg daily on the urinary excretion and plasma levels of 2,8-dihydroxyadenine in patients with adenine phosphoribosyltransferase deficiency.;Secondary Objective: Not applicable.;Primary end point(s): 1. Urinary 2,8-dihydroxyadenine excretion. 2. Plasma 2,8-dihydroxyadenine levels.;Timepoint(s) of evaluation of this end point: At trial dates 28, 56, 84, 112, 140 and 168.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Iceland

Contacts

Public ContactVidar Orn Edvardsson

Landspitali - The National University Hospital of Iceland

vidare@landspitali.is3548245227

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026