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

Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Impairment

Intervention: Febuxostat (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Takeda

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.

Clinical Details

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

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

Primary outcome: Change From Baseline to Month 12 in Serum Creatinine

Secondary outcome:

Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)

Percentage of Participants With Serum Urate (sUA) Less Than 6 mg/dL at Month 12

Mean Clearance (CL/F) of Febuxostat at Steady State

Mean Area Under the Concentration-Time Curve During the Dosing Interval (AUC[0-τ]) of Febuxostat at Steady State

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Locations and Contacts

Birmingham, Alabama, United States

Peoria, Arizona, United States

Sierra Vista, Arizona, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Huntington Park, California, United States

Irvine, California, United States

Lakewood, California, United States

Long Beach, California, United States

Sacramento, California, United States

San Diego, California, United States

San Jose, California, United States

Tustin, California, United States

Arvada, Colorado, United States

Westminster, Colorado, United States

Wheat Ridge, Colorado, United States

Middlebury, Connecticut, United States

Brandon, Florida, United States

Daytona Beach, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Pinellas Park, Florida, United States

Port Charlotte, Florida, United States

Port Orange, Florida, United States

Augusta, Georgia, United States

Conyers, Georgia, United States

Dunwoody, Georgia, United States

Honolulu, Hawaii, United States

Boise, Idaho, United States

Evergreen Park, Illinois, United States

Springfield, Illinois, United States

Valparaiso, Indiana, United States

Wichita, Kansas, United States

Elizabethtown, Kentucky, United States

Paducah, Kentucky, United States

Baltimore, Maryland, United States

Detroit, Michigan, United States

Kalamazoo, Michigan, United States

Brooklyn Center, Minnesota, United States

Neptune City, New Jersey, United States

Morganton, North Carolina, United States

Wilmington, North Carolina, United States

Fargo, North Dakota, United States

Oklahoma City, Oklahoma, United States

Portland, Oregon, United States

Bethlehem, Pennsylvania, United States

Anderson, South Carolina, United States

Greer, South Carolina, United States

Chattanooga, Tennessee, United States

Houston, Texas, United States

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Danville, Virginia, United States

Fairfax, Virginia, United States

Richmond, Virginia, United States

Williamsburg, Virginia, United States

Clarksburg, West Virginia, United States

Wauwatosa, Wisconsin, United States

Additional Information

Uloric Package Insert

FDA Safety Alerts and Recalls

Starting date: April 2010
Last updated: September 23, 2013

Page last updated: August 23, 2015

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