CSP594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat

• Status: Completed
• Trial end date: 2021-04-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Allopurinol; Febuxostat; Uric Acid

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

• Women less than 50 years of age

• Patients with a history of prior solid organ / hematopoietic transplantation

• Previous allergy or intolerance to allopurinol or febuxostat

• Patients who are not candidates for any of the recommended prophylactic medications (colchicine, naprosyn 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 more than one of the following:

• 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, or probenecid

• Patient who are unable to give informed consent

• Enrollment in another randomized interventional clinical trial

• Any severe medical condition that, in the enrollee's opinion, is likely to compromise the participant's ability to complete the trial