CSP594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat

Completed · Phase 4 · Has a placebo group

Conditions studied: Gout, Chronic Kidney Diseases

In brief

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.

Key facts

Study ID

NCT02579096

Run by

VA Office of Research and Development

People needed

950

Starts

2017-03-06

Expected to finish

2021-04-15

Last updated by the study team

2024-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Stage 4 or 5 Chronic Kidney Disease (CKD) - defined as eGFR < 30 ml/min/1.73 m2
• 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 mg/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 mg/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 enrolleer's opinion, is likely to compromise the participant's ability to complete the trial

Where it is running

• VA Loma Linda Healthcare System, Loma Linda, CA — Loma Linda, California, United States
• VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States
• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States
• Miami VA Healthcare System, Miami, FL — Miami, Florida, United States
• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
• Mayo Clinic Rochester MN ? RAIN 1 — Rochester, Minnesota, United States
• Kansas City VA Medical Center, Kansas City, MO — Kansas City, Missouri, United States
• Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha, Nebraska, United States
• University of Nebraska Medical Center ? RAIN 5 — Omaha, Nebraska, United States
• Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY — New York, New York, United States
• Asheville VA Medical Center, Asheville, NC — Asheville, North Carolina, United States
• Sanford Bismarck Medical Center ? RAIN 2 — Bismarck, North Dakota, United States
• Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati, Ohio, United States
• VA Portland Health Care System, Portland, OR — Portland, Oregon, United States
• Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States
• VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States
• Yankton Medical Clinic ? RAIN 3 — Yankton, South Dakota, United States
• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States
• VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States
• White River Junction VA Medical Center, White River Junction, VT — White River Junction, Vermont, United States
• Salem VA Medical Center, Salem, VA — Salem, Virginia, United States

Full record on ClinicalTrials.gov

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