Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
NCT ID: NCT01082640
Last Updated: 2013-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
96 participants
INTERVENTIONAL
2010-04-30
2012-05-31
Brief Summary
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Detailed Description
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Approximately 40-60% of patients with hyperuricemia and gout have some degree of renal impairment. Hyperuricemia has long been associated with renal disease, and chronic hyperuricemia as seen in gout can lead to deposition of urate crystals resulting in diminished renal function.
This study will evaluate the effect of febuxostat on the renal function of patients with hyperuricemia and gout and moderate to severe renal impairment.
All participants must have an average sitting blood pressure measurement less than 160 mmHg systolic and less than 95 mmHg diastolic. All participants must meet the American Rheumatism Association (ARA) diagnostic criteria for gout (subjects with tophi were excluded). Participants are expected to return to the site for approximately 10 visits.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo-matching capsules, orally, twice daily for up to 12 months.
Placebo
Febuxostat placebo-matching capsules
Febuxostat 30 mg BID
Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
Febuxostat
Febuxostat capsules
Febuxostat 40/80 mg QD
Participants initially received febuxostat 40 mg, capsules, once daily (QD) and one placebo-matching capsule QD and remained on this dose for up to 12 months if their serum urate (sUA) was \<6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg, capsule, QD, and one placebo-matching capsule QD at the Month 1 visit, and for the remainder of the study.
Febuxostat
Febuxostat capsules
Placebo
Febuxostat placebo-matching capsules
Interventions
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Febuxostat
Febuxostat capsules
Placebo
Febuxostat placebo-matching capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have a history or presence of gout defined as having one or more of the American Rheumatism Association criteria for the diagnosis of gout (the criteria related to tophi have been excluded for the purpose of the study)
* Must have an estimated Glomerular Filtration Rate (eGFR) of 15 or greater, or less than or equal to 50 mL/min, AND a serum creatinine greater than 1.5 mg/dL at Screening Visit Day -21
Exclusion Criteria
* Has tophaceous gout
* Has a history of xanthinuria
* Has received aspirin greater than 325 mg/day within 35 days prior to Day 1/Randomization Visit
* Has known hypersensitivity or allergy to allopurinol or any component in its formulation
* Has known hypersensitivity to febuxostat or colchicine or any components in their formulation
* Has myocardial infarction or stroke within the 90 days prior to the Screening Visit
* Has alanine aminotransferase and/or aspartate aminotransferase values greater than 2.0 times the upper limit of normal
* Has end stage renal disease or is likely to be a candidate for dialysis over the 1 year study period
* Has a serum creatinine less than or equal to 1.5 mg/dL, or an estimated Glomerular Filtration Rate at Day -21 Screening Visit less than 15 mL/min or greater than 50 mL/min as calculated by the central laboratory
* Is required to take excluded medications
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Birmingham, Alabama, United States
Peoria, Arizona, United States
Sierra Vista, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Huntington Park, California, United States
Irvine, California, United States
Lakewood, California, United States
Long Beach, California, United States
Sacramento, California, United States
San Diego, California, United States
San Jose, California, United States
Tustin, California, United States
Arvada, Colorado, United States
Westminster, Colorado, United States
Wheat Ridge, Colorado, United States
Middlebury, Connecticut, United States
Brandon, Florida, United States
Daytona Beach, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Pinellas Park, Florida, United States
Port Charlotte, Florida, United States
Port Orange, Florida, United States
Augusta, Georgia, United States
Conyers, Georgia, United States
Dunwoody, Georgia, United States
Honolulu, Hawaii, United States
Boise, Idaho, United States
Evergreen Park, Illinois, United States
Springfield, Illinois, United States
Valparaiso, Indiana, United States
Wichita, Kansas, United States
Elizabethtown, Kentucky, United States
Paducah, Kentucky, United States
Baltimore, Maryland, United States
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
Brooklyn Center, Minnesota, United States
Neptune City, New Jersey, United States
Morganton, North Carolina, United States
Wilmington, North Carolina, United States
Fargo, North Dakota, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Bethlehem, Pennsylvania, United States
Anderson, South Carolina, United States
Greer, South Carolina, United States
Chattanooga, Tennessee, United States
Houston, Texas, United States
Odessa, Texas, United States
San Antonio, Texas, United States
Danville, Virginia, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Williamsburg, Virginia, United States
Clarksburg, West Virginia, United States
Wauwatosa, Wisconsin, United States
Countries
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References
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Saag KG, Whelton A, Becker MA, MacDonald P, Hunt B, Gunawardhana L. Impact of Febuxostat on Renal Function in Gout Patients With Moderate-to-Severe Renal Impairment. Arthritis Rheumatol. 2016 Aug;68(8):2035-43. doi: 10.1002/art.39654.
Related Links
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Other Identifiers
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TMX-67_203
Identifier Type: -
Identifier Source: org_study_id
U1111-1113-8008
Identifier Type: REGISTRY
Identifier Source: secondary_id