Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment

Completed · Phase 2 · Has a placebo group

Conditions studied: Renal Impairment

In brief

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.

Key facts

Study ID

NCT01082640

Run by

Takeda

People needed

96

Starts

2010-04-01

Expected to finish

2012-05-01

Last updated by the study team

2013-09-25

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Peoria, Arizona, United States
• Study site — Sierra Vista, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Huntington Park, California, United States
• Study site — Irvine, California, United States
• Study site — Lakewood, California, United States
• Study site — Long Beach, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Jose, California, United States
• Study site — Tustin, California, United States
• Study site — Arvada, Colorado, United States
• Study site — Westminster, Colorado, United States
• Study site — Wheat Ridge, Colorado, United States
• Study site — Middlebury, Connecticut, United States
• Study site — Brandon, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — Port Charlotte, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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