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the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More

Study acronym: TARGET
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Apr 30, 2026 to Feb 19, 2027 · Start date changed from estimate of Oct 15, 2024 to Sep 10, 2025 · Completion date: Oct 14, 2026 to Aug 19, 2027 · 2 morev2 Show 5 more changesShow less
    • Primary completion date: Apr 30, 2026 to Feb 19, 2027
    • Start date changed from estimate of Oct 15, 2024 to Sep 10, 2025
    • Completion date: Oct 14, 2026 to Aug 19, 2027
    • Site details revised
    • Collaborators revised (6)

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to compare the changes in serum urate levels and symptom recurrence after reducing or suspending urate-lowering agents in well-controlled gout patients (the 'after dishes are clean' state in the Dirty Dish hypothesis) Researchers will compare three randomized groups: the reducing group takes febuxostat 20 mg once daily for 12 months, the discontinuing group takes a placebo once daily for 6 months, followed by febuxostat 20 mg once daily for the next 6 months, and the maintaining group continues their pre-study urate-lowering agents for 12 months, serving as an observational reference group. During the 12-month study period, participants will visit every 3 months for laboratory evaluations including serum urate levels, and for checking symptomatic status using questionnaires and diaries. Additionally, musculoskeletal ultrasonography and serum sample collection will be performed at baseline to study predictors for maintaining serum urate levels \<7.0 mg/dL after reducing or suspending urate-lowering therapy.
Trial Details
NCT Number NCT06622603
Lead Sponsor Seoul National University Hospital
Collaborators: Gachon University Gil Medical Center, SMG-SNU Boramae Medical Center, Chungnam National University Hospital, Seoul National University Bundang Hospital, Uijeongbu Eulji University Hospital, Ajou University Medical Center
Conditions Gout, Uric Acid
Enrollment 59 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov