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
2 other identifiers
interventional
96
1 country
58
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2010
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2010
CompletedFirst Posted
Study publicly available on registry
March 8, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
September 25, 2013
CompletedSeptember 25, 2013
September 1, 2013
2.1 years
March 5, 2010
May 31, 2013
September 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Month 12 in Serum Creatinine
Renal function was assessed by measuring the change from Baseline in serum creatinine. Analyses were conducted by the Central Laboratory.
Baseline and Month 12
Secondary Outcomes (4)
Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)
Baseline and Month 12
Percentage of Participants With Serum Urate (sUA) Less Than 6 mg/dL at Month 12
Month 12
Mean Clearance (CL/F) of Febuxostat at Steady State
The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours.
Mean Area Under the Concentration-Time Curve During the Dosing Interval (AUC[0-Ï„]) of Febuxostat at Steady State
The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours.
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo-matching capsules, orally, twice daily for up to 12 months.
Febuxostat 30 mg BID
EXPERIMENTALFebuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
Febuxostat 40/80 mg QD
EXPERIMENTALParticipants initially received febuxostat 40 mg, capsules, once daily (QD) and one placebo-matching capsule QD and remained on this dose for up to 12 months if their serum urate (sUA) was \<6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg, capsule, QD, and one placebo-matching capsule QD at the Month 1 visit, and for the remainder of the study.
Interventions
Febuxostat capsules
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (58)
Unknown Facility
Birmingham, Alabama, United States
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Peoria, Arizona, United States
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Sierra Vista, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Huntington Park, California, United States
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Irvine, California, United States
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Lakewood, California, United States
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Long Beach, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Tustin, California, United States
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Arvada, Colorado, United States
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Westminster, Colorado, United States
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Wheat Ridge, Colorado, United States
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Middlebury, Connecticut, United States
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Brandon, Florida, United States
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Daytona Beach, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Pinellas Park, Florida, United States
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Port Charlotte, Florida, United States
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Port Orange, Florida, United States
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Augusta, Georgia, United States
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Conyers, Georgia, United States
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Dunwoody, Georgia, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Evergreen Park, Illinois, United States
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Springfield, Illinois, United States
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Valparaiso, Indiana, United States
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Wichita, Kansas, United States
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Elizabethtown, Kentucky, United States
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Paducah, Kentucky, United States
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Baltimore, Maryland, United States
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Detroit, Michigan, United States
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Kalamazoo, Michigan, United States
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Brooklyn Center, Minnesota, United States
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Neptune City, New Jersey, United States
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Morganton, North Carolina, United States
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Wilmington, North Carolina, United States
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Fargo, North Dakota, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Anderson, South Carolina, United States
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Greer, South Carolina, United States
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Chattanooga, Tennessee, United States
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Houston, Texas, United States
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Odessa, Texas, United States
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San Antonio, Texas, United States
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Danville, Virginia, United States
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Fairfax, Virginia, United States
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Richmond, Virginia, United States
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Williamsburg, Virginia, United States
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Clarksburg, West Virginia, United States
Unknown Facility
Wauwatosa, Wisconsin, United States
Related Publications (1)
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.
PMID: 26894653DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP, Clinical Science
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2010
First Posted
March 8, 2010
Study Start
April 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
September 25, 2013
Results First Posted
September 25, 2013
Record last verified: 2013-09