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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01350388
First Posted: May 9, 2011
Last Update Posted: October 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda
Information provided by (Responsible Party):
Srinvasan Beddhu, University of Utah
Results First Submitted: June 6, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Febuxostat Febuxostat: 80 mg/day of febuxostat for 24 weeks
Placebo Placebo: 1 placebo tablet per day for 24 weeks

Participant Flow:   Overall Study
    Febuxostat   Placebo
STARTED   40   40 
COMPLETED   37   39 
NOT COMPLETED   3   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Febuxostat Febuxostat: 80 mg/day of febuxostat for 24 weeks
Placebo Placebo: 1 placebo tablet per day for 24 weeks
Total Total of all reporting groups

Baseline Measures
   Febuxostat   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   80 
Age 
[Units: Years]
Mean (Standard Deviation)
 67  (10)   68  (11)   68  (10) 
Gender 
[Units: Participants]
     
Female   16   12   28 
Male   24   28   52 
Plasma Uric Acid Level 
[Units: Milligram per deciliter]
Mean (Standard Deviation)
 7.2  (1.5)   7.1  (1.2)   7.2  (1.4) 
Estimated Glomerular Filtration Rate (eGFR) 
[Units: Milliliters per minute]
Mean (Standard Deviation)
 52.2  (15.3)   54.8  (19.0)   53.5  (17.2) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Thiobarbituric Acid Reactive Substance (TBARS) Concentration in Adipose Tissue From Baseline to 24 Weeks   [ Time Frame: Baseline and 24 weeks ]

2.  Primary:   Change in Adiponectin Concentration in Adipose Tissue From Baseline to 24 Weeks   [ Time Frame: Baseline and 24 weeks ]

3.  Primary:   Change in Urinary Concentrations of Transforming Growth Factor-beta1 (TGF-beta1) From Baseline to 24 Weeks   [ Time Frame: Baseline and 24 weeks ]

4.  Secondary:   Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 24 Weeks   [ Time Frame: Baseline and 24 weeks ]

5.  Secondary:   Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 24 Weeks   [ Time Frame: Baseline and 24 weeks ]

6.  Secondary:   Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 24 Weeks   [ Time Frame: Baseline and 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: srinivansan.beddhu@hsc.utah.edu



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