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

This study is currently recruiting participants.
Verified May 2013 by University of Utah
Sponsor:
Collaborator:
Takeda Pharmaceutical Company Limited
Information provided by (Responsible Party):
Srinvasan Beddhu, University of Utah
ClinicalTrials.gov Identifier:
NCT01350388
First received: April 20, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

Hyperuricemia is emerging as a risk factor for development of diabetes and metabolic syndrome. Recently, it was shown in in-vitro cell culture experiments that hyperuricemia induces redox-dependent signaling and oxidative stress in adipocytes. By targeting levels of uric acid with febuxostat we hypothesize that the levels of oxidative stress in adipose tissue (obtained by fat biopsy) will decrease.

Primary aims of the study is to determine whether febuxostat therapy in overweight or obese, diabetic patients with stage 3 CKD and high serum uric acid levels

  1. decreases adipose tissue concentrations of thiobarbituric acid reactive substance (TBARS), a marker of oxidative stress
  2. increases adipose tissue expression and concentrations of adiponectin and
  3. decreases urinary concentrations of transforming growth factor (TGF)- B1.

Condition Intervention
Chronic Kidney Disease
Diabetes
 Drug: Febuxostat
Drug: Sugar pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Febuxostat on Adipokines and Kidney Disease in Diabetic Chronic Kidney Disease

Resource links provided by NLM:

Drug Information available for: Febuxostat
U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Effects of Febuxostat on TBARS, adiponectin and transforming growth factor [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    To determine whether febuxostat therapy in overweight or obese, diabetic patients with stage 3 CKD and high serum uric acid levels

    1. decreases adipose tissue concentrations of thiobarbituric acid reactive substance (TBARS), a marker of oxidative stress
    2. increases adipose tissue expression and concentrations of adiponectin and
    3. decreases urinary concentrations of transforming growth factor (TGF)- B1.


Secondary Outcome Measures:
  • Effects of Febuxostat on plasma adiponectin, TNF-alpha, IL-6, hsCRP and albumin [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    To determine whether febuxostat therapy in overweight or obese, diabetic patients with stage 3 CKD and high serum uric acid levels

    1. increases plasma concentrations of adiponectin
    2. decreases adipose tissue expression and concentrations of TNF-alpha and IL-6 and
    3. decreases plasma concentrations of TNF-alpha, IL-6 and high sensitivity C-reactive protein (hsCRP) and
    4. decreases urinary concentrations of albumin


Estimated Enrollment: 80
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Febuxostat Drug: Febuxostat
80 mg/day of febuxostat for 6 months
Other Name: Uloric
Placebo Comparator: Sugar pill Drug: Sugar pill
1 pill a day for 6 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • BMI > 25 kg/m2
  • type 2 diabetes
  • serum uric acid ≥ 5.5 mg/dl in men and ≥ 4.6 mg/dl in women
  • eGFR 30-60 mL/min/1.73m2

Exclusion Criteria:

  • History of gout
  • concurrent use of azathioprine, mercaptopurine, theophylline, allopurinol, thiazolidinediones or warfarin
  • concurrent use of metformin
  • current antibiotic therapy
  • pregnant women
  • prisoners
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350388

Contacts
Contact: Srinivasan Beddhu, MD 801-581-3810 srinivasan.beddhu@hsc.utah.edu
Contact: Rebecca Filipowicz, MS 801-587-5868 rebecca.filipowicz@hsc.utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Rebecca Filipowicz, MS     801-587-5868     rebecca.filipowicz@hsc.utah.edu    
Principal Investigator: Srinivasan Beddhu, MD            
Sponsors and Collaborators
University of Utah
Takeda Pharmaceutical Company Limited
Investigators
Principal Investigator: Srinivasan Beddhu, MD University of Utah
  More Information

No publications provided

Responsible Party: Srinvasan Beddhu, Srinivasan Beddhu, MD Associate Professor of Medicine, University of Utah
ClinicalTrials.gov Identifier: NCT01350388     History of Changes
Other Study ID Numbers: IRB_00044016
Study First Received: April 20, 2011
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Chronic Kidney Disease
Diabetes
Febuxostat
Inflammation

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Urologic Diseases
Renal Insufficiency
Febuxostat
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013