Gout: Allopurinol vs. Febuxostat

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 17-001211
    NCT ID: NCT02579096
    Sponsor Protocol Number: CSP594

About this study

This trial will compare two effective therapies, allopurinol and febuxostat, to lower serum uric acid and therefore prevent further gout attaches. These therapies have never been compared at appropriate doses. Further, they will be study in patients with kidney disease for the first time.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Age 18 years.
  • History of gout - crystal proven or historical as defined by ACR criteria listed above.
  • Serum urate level 6.8 mg/dl.

Exclusion Criteria:

  • Stage 4 or 5 Chronic Kidney Disease (CKD) – defined as eGFR of <30 ml/min/1.73 m2.
  • Women younger than 50 years of age.
  • Patients with a history of prior solid organ / hematopoietic transplantation.
  • Previous allergy or intolerance to allopurinol.
  • Patients who are not candidates for any of the recommended prophylactic medications (colchicine, naproxen or glucocorticoids).
  • Patients who in the opinion of the investigator have a high genetic risk for allopurinol hypersensitivity syndrome (AHS*) unless they have been found to be negative for HLA B5801.
  • Previous history of failure to reach target uric acid levels despite therapy with allopurinol at dose > 300 mg/day.
  • Prior febuxostat use.
  • Patients with malignancies that are currently active with exception of non-melanoma skin cancer.
  • Patients with serum uric acid levels >15 mg/dl.
  • Patients with myelodysplasia and hemoglobin of < 8.5 g/dL.
  • Patients with chronic liver disease with two or more of the following occurring within the past six months:
    • INR ≥1.7, not on Warfarin therapy;
    • Bilirubin ≥2 mg/dL;
    • Serum albumin <3.5 g/dL;
    • Ascites;
    • Encephalopathy.
  • Current use of azathioprine, mercaptopurine, didanosine, cyclophosphamide, probenecid** lesinurad or pegloticase***.
  • Enrollment in another randomized interventional clinical trial****.
  • Any severe medical condition that, in the enroller's opinion, is likely to compromise the participant's ability to complete the trial (e.g. unable to give informed consent).
  • *Please see operational manual for further discussion on genetic risk for AHS.
  • ** Participants on probenecid may be enrolled in the study provided that they undergo a 14-day wash-out period before study entry.
  • *** Urate-lowering therapies approved after study kickoff are also excluded.
  • **** Unless the randomized interventional clinical trial is approved for dual enrollment by VACO.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Lynne Peterson, M.D.

Contact us for the latest status

Contact information:

Jennifer Sletten

7743695

Sletten.Jennifer@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20347034

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