Phase 2
N=96
Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
Renal Impairment
Bottom Line
View on ClinicalTrials.gov: NCT01082640 ↗Enrolled (actual)
96
Serious AEs
20.8%
Results posted
Sep 2013
Primary outcome: Primary: Change From Baseline to Month 12 in Serum Creatinine — 2.52; 2.10; 2.22; 0.19 mg/dL — p=0.459
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Febuxostat (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Month 12 in Serum Creatinine |
2.52; 2.10; 2.22; 0.19; 0.09; 0.23 | 0.459 |
| SECONDARY Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR) |
29.31; 34.14; 34.08; -2.05; 0.33; -0.86 | 0.162 |
| SECONDARY Percentage of Participants With Serum Urate (sUA) Less Than 6 mg/dL at Month 12 |
0; 68.8; 45.2 | <0.001 sig |
| SECONDARY Mean Clearance (CL/F) of Febuxostat at Steady State |
8.16; 8.71; 10.9 | — |
| SECONDARY Mean Area Under the Concentration-Time Curve During the Dosing Interval (AUC[0-τ]) of Febuxostat at Steady State |
3.98; 4.91; 8.21 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01082640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.