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Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 19 to 79

Lowering or stopping febuxostat in people with gout who have been well controlled for 5+ years

Official title: A Prospective, Multicenter, Randomized Investigator Initiative Clinical Trial Study on the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More

Run by Seoul National University Hospital · NCT06622603 · Data updated 2026-11-12

This test will see if reducing or briefly stopping febuxostat keeps uric acid low and prevents symptom return in people with gout who have had good control for at least five years.

More Gout trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages19 Years to 79 Years
SexAll
Enrollment59 (estimated)
SponsorSeoul National University Hospital
Academic / other
Locations1 site (Seongnam-si, Gyeonggi-do)
StatusRecruiting
StartedSeptember 10, 2025
Main results expectedFebruary 19, 2027
Study endsAugust 19, 2027
Registry record updatedApril 29, 2026
Trial IDNCT06622603 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 19–79 years with gout who have been on continuous urate-lowering therapy for ≥5 years, have serial serum urate measurements showing long-term control (<6.0 mg/dL or low AUC), no visible/palpable tophi, no flares or kidney stones in the past year, and eGFR ≥60 mL/min/1.73 m² are ideal candidates.

Probably not a fit

Patients with recent gout flares, palpable/visible tophi, history of nephrolithiasis in the past year, reduced kidney function (eGFR <60), or insufficient long-term urate data are unlikely to benefit from tapering or stopping therapy in this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will randomize long-term well-controlled gout patients into three groups: a reducing group taking febuxostat 20 mg once daily for 12 months, a discontinuing group taking placebo for 6 months followed by febuxostat 20 mg for 6 months, and a maintaining group continuing their usual urate-lowering therapy for 12 months as a reference. Participants will attend quarterly visits for serum urate measurements, symptom questionnaires, and diaries over the 12-month period. Baseline musculoskeletal ultrasound and stored serum samples will be collected to explore predictors of maintaining serum urate <7.0 mg/dL after dose change. The trial enrolls adults who have been on urate-lowering therapy for at least 5 years with consistently low urate and no recent flares, tophi, or kidney stones.

Why it matters

Potential benefit: If successful, this approach could let some long-term controlled gout patients reduce or stop medication while keeping uric acid under control and lowering medication burden.

How similar studies have gone: Some observational reports suggest patients with sustained low urate for years can remain flare-free if levels stay <7 mg/dL, but randomized evidence on formal dose tapering or temporary discontinuation is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
* Inclusion Criteria:

  1. Adult gout patients aged ≥19 but \<80 years.
  2. Gout patients treated with urate-lowering therapy (either allopurinol or febuxostat monotherapy, or a combination of two agents) for at least the past 5 years.
  3. Patients who have at least five serum urate level measurements over the past 5 years and meet one of the following criteria:

     All serum urate levels measured in the past 5 years have been maintained below 6.0 mg/dL; or the area under the curve (AUC) of serum urate levels over time for the past 5 years is less than 33.0 mg/dL x year
  4. Patients without palpable or visible tophi on physical examination (evaluated at pre-defined 18 joint sites and the ears).
  5. Patients without acute gouty attack or history of nephrolithiasis in the past 12 months
  6. Patients with an estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73m² or higher, based on the Cockcroft-Gault formula.
  7. Patients who voluntarily provide written informed consent to participate.
* Exclusion Criteria:

  1. Subjects who continuously require prophylactic low-dose colchicine/NSAIDs.
  2. Subjects already having taken low-dose urate-lowering agents. The low-dose urate-lowering agents are defined as allopurinol ≤200 mg/day or febuxostat ≤20 mg/day. But patients on a combination of low-dose allopurinol and febuxostat are eligible.
  3. Subjects taking medications that could affect serum uric acid levels and uric acid fractional excretion rates, such as benzbromarone, fenofibrate, loop diuretics, thiazide or thiazide-like diuretics, and losartan.
  4. Subjects classified as having high-risk alcohol use according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA):

     For men \<65 years: more than 14 drinks per week or for men ≥65 years or women: more than 7 drinks per week
  5. Subjects with a history of hypersensitivity to febuxostat or allopurinol
  6. Subjects with unstable cardiovascular conditions, who require adjustment of urgent their therapy
  7. Subjects taking mercaptopurine or azathioprine
  8. Subjects with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  9. Subjects with moderate or severe liver dysfunction (AST or ALT levels greater than 3 times the upper normal limit)
  10. Subjects for whom investigators anticipate that a change in a urate-lowering agent dose could present significant risks or that any factor could severely impact drug adherence, complicating study registration.

Where it's running

  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do, South Korea     Recruiting

Study contacts

  • Principal investigator: Yun Jong Lee, MD, PhD — Seoul National University Bundang Hospital
  • Study coordinator: Yun Jong Lee, MD, PhD
  • Email: yn35@snu.ac.kr
  • Phone: 82317877051

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.