Gout: Allopurinol vs. Febuxostat

Overview

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.

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

(507)284-3695

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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