Trial · NCT01082640
Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
NCT01082640, Phase 2, Completed, Takeda; results first posted 2013-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment. Trials, record NCT01082640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01082640
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
- NCT number
- NCT01082640
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 96 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Renal Impairment
- Interventions
- Febuxostat, Placebo
- First posted
- 2010-03-08
- Last updated
- 2013-09-25
- Results first posted
- 2013-09-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Month 12 in Serum Creatinine | Baseline and Month 12 | Renal function was assessed by measuring the change from Baseline in serum creatinine. Analyses were conducted by the Central Laboratory. |
| Secondary | Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR) | Baseline and Month 12 | Change from baseline to Month 12 in estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula (as calculated by the central laboratory). |
| Secondary | Percentage of Participants With Serum Urate (sUA) Less Than 6 mg/dL at Month 12 | Month 12 | Serum urate concentrations were determined using the enzymatic method as performed by the Central Laboratory. |
| Secondary | 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 CL/F at steady state were estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose. |
| Secondary | Mean Area Under the Concentration-Time Curve During the Dosing Interval (AUC[0-τ]) 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 AUC during the dosing interval at steady state was estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Month 12 in Serum Creatinine | Baseline and Month 12 | Full analysis set, including all patients who were randomized and received at least 1 dose of double-blind study medication. Only patients with both a baseline value and at least 1 value during the double-blind treatment period are included in the analysis. Missing data were imputed as carrying forward the last observed post-baseline value. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR) | Baseline and Month 12 | Full analysis set with available data at Baseline. and at least 1 post-baseline value. Missing data was imputed as carrying forward the last post-baseline value. | mL/min/1.73m² | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Serum Urate (sUA) Less Than 6 mg/dL at Month 12 | Month 12 | Full analysis set, including all patients who were randomized and received at least 1 dose of double-blind study medication. A patient was included in the analysis only when there was at least 1 value during the double-blind treatment period. Missing data were imputed as carrying forward the last observed post-baseline value. | percentage of participants | NUMBER |
| SECONDARY | 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. | Participants who received febuxostat and had available data for PK analysis. | liters/hour | MEAN |
| SECONDARY | Mean Area Under the Concentration-Time Curve During the Dosing Interval (AUC[0-τ]) 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. | Participants who received febuxostat and had available data for PK analysis. | hr*µg/mL | MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Month 12 in Serum Creatinine | Placebo | Baseline | 2.52 | Standard Error 0.126 | mg/dL |
| Change From Baseline to Month 12 in Serum Creatinine | Febuxostat 30 mg BID | Baseline | 2.10 | Standard Error 0.126 | mg/dL |
| Change From Baseline to Month 12 in Serum Creatinine | Febuxostat 40/80 mg QD | Baseline | 2.22 | Standard Error 0.128 | mg/dL |
| Change From Baseline to Month 12 in Serum Creatinine | Placebo | Change from Baseline at Month 12 | 0.19 | Standard Error 0.094 | mg/dL |
| Change From Baseline to Month 12 in Serum Creatinine | Febuxostat 30 mg BID | Change from Baseline at Month 12 | 0.09 | Standard Error 0.093 | mg/dL |
| Change From Baseline to Month 12 in Serum Creatinine | Febuxostat 40/80 mg QD | Change from Baseline at Month 12 | 0.23 | Standard Error 0.094 | mg/dL |
| Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR) | Placebo | Baseline | 29.31 | Standard Error 1.461 | mL/min/1.73m² |
| Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR) | Febuxostat 30 mg BID | Baseline | 34.14 | Standard Error 1.461 | mL/min/1.73m² |
| Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR) | Febuxostat 40/80 mg QD | Baseline | 34.08 | Standard Error 1.484 | mL/min/1.73m² |
| Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR) | Placebo | Change from Baseline at Month 12 | -2.05 | Standard Error 1.198 | mL/min/1.73m² |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 32 | |
| Overall Study | STARTED | Febuxostat 30 mg BID | 32 | |
| Overall Study | STARTED | Febuxostat 40/80 mg QD | 32 | |
| Overall Study | COMPLETED | Placebo | 15 | |
| Overall Study | COMPLETED | Febuxostat 30 mg BID | 17 | |
| Overall Study | COMPLETED | Febuxostat 40/80 mg QD | 24 | |
| Overall Study | NOT COMPLETED | Placebo | 17 | |
| Overall Study | NOT COMPLETED | Febuxostat 30 mg BID | 15 | |
| Overall Study | NOT COMPLETED | Febuxostat 40/80 mg QD | 8 |
Source ClinicalTrials.gov
Adverse events183
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood creatinine increased | Investigations | Placebo | 1 | 32 | |
| other | Blood creatinine increased | Investigations | Febuxostat 30 mg BID | 5 | 32 | |
| other | Blood creatinine increased | Investigations | Febuxostat 40/80 mg QD | 2 | 32 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 1 | 32 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Febuxostat 30 mg BID | 2 | 32 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Febuxostat 40/80 mg QD | 2 | 32 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Placebo | 2 | 32 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Febuxostat 30 mg BID | 3 | 32 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Febuxostat 40/80 mg QD | 3 | 32 | |
| other | Renal impairment | Renal and urinary disorders | Placebo | 2 | 32 |
1 to 10 of 183Source ClinicalTrials.gov
See all 183 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Febuxostat 30 mg BID | ||
| Total, all-cause mortality | Febuxostat 40/80 mg QD | ||
| Total, other adverse events | Placebo | 20 | 32 |
| Total, other adverse events | Febuxostat 30 mg BID | 21 | 32 |
| Total, other adverse events | Febuxostat 40/80 mg QD | 23 | 32 |
| Total, serious adverse events | Placebo | 7 | 32 |
| Total, serious adverse events | Febuxostat 30 mg BID | 5 | 32 |
| Total, serious adverse events | Febuxostat 40/80 mg QD | 8 | 32 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26894653 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01082640
GET https://conductscience.org/api/trials/v1/NCT01082640/results?page=2