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

2014-08-27 03:15:23 | BioPortfolio

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 subjects with elevated serum urate levels and who have moderate to severe renal impairment.

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 subjects with hyperuricemia and gout and moderate to severe renal impairment.

All subjects must have an average sitting blood pressure measurement less than 160 mmHg systolic and less than 95 mmHg diastolic. All subjects must meet the American Rheumatism Association (ARA) diagnostic criteria for gout. Subjects are expected to return to the site for approximately 11 visits.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Renal Impairment

Intervention

Febuxostat, Febuxostat, Placebo

Location

Sierra Vista
Arizona
United States

Status

Recruiting

Source

Takeda Global Research & Development Center, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:23-0400

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Medical and Biotech [MESH] Definitions

A thiazole derivative and inhibitor of XANTHINE OXIDASE that is used for the treatment of HYPERURICEMIA in patients with chronic GOUT.

The prototypical uricosuric agent. It inhibits the renal excretion of organic anions and reduces tubular reabsorption of urate. Probenecid has also been used to treat patients with renal impairment, and, because it reduces the renal tubular excretion of other drugs, has been used as an adjunct to antibacterial therapy.

The amount of PLASMA that perfuses the KIDNEYS per unit time, approximately 10% greater than effective renal plasma flow (RENAL PLASMA FLOW, EFFECTIVE). It should be differentiated from the RENAL BLOOD FLOW; (RBF), which refers to the total volume of BLOOD flowing through the renal vasculature, while the renal plasma flow refers to the rate of plasma flow (RPF).

Persistent high BLOOD PRESSURE due to KIDNEY DISEASES, such as those involving the renal parenchyma, the renal vasculature, or tumors that secrete RENIN.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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