NCT01082640

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Febuxostat	Febuxostat capsules
DRUG	Placebo	Febuxostat placebo-matching capsules

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-03-08
• Last updated: 2013-09-25
• Results posted: 2013-09-25

Locations

58 sites across 1 country: United States