Renal Impairment Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Phase 2 Study to Evaluate the Effect of Febuxostat Versus Placebo on Renal Function in Gout Subjects With Hyperuricemia and Moderate to Severe Renal Impairment
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.
Gout is caused by high levels of uric acid in the body, and is associated with a broad range
of conditions including heart disease, chronic kidney disease and high blood pressure.
Hyperuricemia, which is defined as an elevation in serum urate levels, develops into gout
when urate crystals form in the body and settle in joints and other organs.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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