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Effects of Febuxostat on Adipokines and Kidney Disease in Diabetic Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01350388
Recruitment Status : Completed
First Posted : May 9, 2011
Results First Posted : October 3, 2016
Last Update Posted : October 3, 2016
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Srinvasan Beddhu, University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Kidney Disease
Diabetes
Interventions Drug: Febuxostat
Drug: Placebo
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Febuxostat Placebo
Hide Arm/Group Description Febuxostat: 80 mg/day of febuxostat for 24 weeks Placebo: 1 placebo tablet per day for 24 weeks
Period Title: Overall Study
Started 40 40
Completed 37 39
Not Completed 3 1
Arm/Group Title Febuxostat Placebo Total
Hide Arm/Group Description Febuxostat: 80 mg/day of febuxostat for 24 weeks Placebo: 1 placebo tablet per day for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
67  (10) 68  (11) 68  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
16
  40.0%
12
  30.0%
28
  35.0%
Male
24
  60.0%
28
  70.0%
52
  65.0%
Plasma Uric Acid Level  
Mean (Standard Deviation)
Unit of measure:  Milligram per deciliter
Number Analyzed 40 participants 40 participants 80 participants
7.2  (1.5) 7.1  (1.2) 7.2  (1.4)
Estimated Glomerular Filtration Rate (eGFR)  
Mean (Standard Deviation)
Unit of measure:  Milliliters per minute
Number Analyzed 40 participants 40 participants 80 participants
52.2  (15.3) 54.8  (19.0) 53.5  (17.2)
1.Primary Outcome
Title Change in Thiobarbituric Acid Reactive Substance (TBARS) Concentration in Adipose Tissue From Baseline to 24 Weeks
Hide Description The percent difference in thiobarbituric acid reactive substance (TBARS) concentration geometric mean values from baseline to 24 weeks was calculated for each arm
Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat Placebo
Hide Arm/Group Description:
Febuxostat: 80 mg/day of febuxostat for 24 weeks
Placebo: 1 placebo tablet per day for 24 weeks
Overall Number of Participants Analyzed 37 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: percent difference in geometric mean
34.0
(-26.3 to 143.4)
44.6
(-19.3 to 159.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Change in Adiponectin Concentration in Adipose Tissue From Baseline to 24 Weeks
Hide Description The percent difference in adiponectin concentration geometric mean values from baseline to 24 weeks was calculated for each arm
Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat Placebo
Hide Arm/Group Description:
Febuxostat: 80 mg/day of febuxostat for 24 weeks
Placebo: 1 placebo tablet per day for 24 weeks
Overall Number of Participants Analyzed 37 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: percent difference in geometric mean
2.3
(-23.4 to 36.7)
-4.1
(-27.7 to 27.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Change in Urinary Concentrations of Transforming Growth Factor-beta1 (TGF-beta1) From Baseline to 24 Weeks
Hide Description The percent difference in TGF-beta1 concentration geometric mean values from baseline to 24 weeks was calculated for each arm
Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat Placebo
Hide Arm/Group Description:
Febuxostat: 80 mg/day of febuxostat for 24 weeks
Placebo: 1 placebo tablet per day for 24 weeks
Overall Number of Participants Analyzed 37 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: percent difference in geometric mean
29.8
(4.4 to 61.5)
10.0
(-10.8 to 35.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 24 Weeks
Hide Description The percent difference in plasma TNF-α concentration geometric mean values from baseline to 24 weeks was calculated for each arm
Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat Placebo
Hide Arm/Group Description:
Febuxostat: 80 mg/day of febuxostat for 24 weeks
Placebo: 1 placebo tablet per day for 24 weeks
Overall Number of Participants Analyzed 37 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: percent difference in geometric mean
-9.9
(-30.6 to 16.8)
-7.4
(-28.3 to 19.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 24 Weeks
Hide Description The percent difference in plasma IL-6 concentration geometric mean values from baseline to 24 weeks was calculated for each arm
Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat Placebo
Hide Arm/Group Description:
Febuxostat: 80 mg/day of febuxostat for 24 weeks
Placebo: 1 placebo tablet per day for 24 weeks
Overall Number of Participants Analyzed 37 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: percent difference in geometric mean
-24.0
(-35.3 to -10.7)
-9.5
(-22.7 to 6.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 24 Weeks
Hide Description The percent difference in plasma hsCRP concentration geometric mean values from baseline to 24 weeks was calculated for each arm
Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Febuxostat Placebo
Hide Arm/Group Description:
Febuxostat: 80 mg/day of febuxostat for 24 weeks
Placebo: 1 placebo tablet per day for 24 weeks
Overall Number of Participants Analyzed 37 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: percent difference in geometric mean
12.2
(-16.3 to 50.3)
-7.2
(-30.5 to 23.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Febuxostat, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame 24 Weeks
Adverse Event Reporting Description Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through week 24.
 
Arm/Group Title Febuxostat Placebo
Hide Arm/Group Description Febuxostat: 80 mg/day of febuxostat for 24 weeks Placebo: 1 placebo tablet per day for 24 weeks
All-Cause Mortality
Febuxostat Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Febuxostat Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/40 (2.50%)      3/40 (7.50%)    
Cardiac disorders     
Atrial Fibrillation  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Aortic Valve Disease  1  1/40 (2.50%)  1 0/40 (0.00%)  0
General disorders     
Flu-like Symptoms  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Hepatobiliary disorders     
Cholecystitis  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Nervous system disorders     
Ischemic Stroke  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Febuxostat Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      0/40 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Srinivasan Beddhu, M.D.
Organization: University of Utah
Phone: 801-585-3810
Responsible Party: Srinvasan Beddhu, University of Utah
ClinicalTrials.gov Identifier: NCT01350388     History of Changes
Other Study ID Numbers: IRB_00044016
First Submitted: April 20, 2011
First Posted: May 9, 2011
Results First Submitted: June 6, 2016
Results First Posted: October 3, 2016
Last Update Posted: October 3, 2016