The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice
daily (BID), on renal function in gout patients with elevated serum urate levels and who
have moderate to severe renal impairment.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Must have a serum urate greater than 7 mg/dL and a serum creatinine greater than or
equal to 1. 5 mg at Day - 21
- 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 secondary hyperuricemia (eg, due to myeloproliferative disorder, or organ
transplant)
- 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
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