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

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.

Timeline

Start

2010-04

Primary completion

2012-05

Completion

2012-05

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Febuxostat 30 mg BID; p = 0.459; LS mean difference -0.10 (95% CI -0.37 to 0.17); ANCOVA; note: No adjustment for multiplicity was made. NCT01082640 ↗

paper At month 12, there were no significant differences in the change in serum Cr level from baseline, or in the change in estimated GFR from baseline, in either febuxostat group compared to the placebo group. PMID 26894653 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Febuxostat	Small molecule	30 mg	Oral
Subject	Febuxostat	Small molecule	40 mg	Oral
Subject	Febuxostat	Small molecule	80 mg	Oral

Indications