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Uric Acid and the Endothelium in CKD

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ClinicalTrials.gov Identifier: NCT01228903
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : February 23, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This study will test the hypothesis that uric acid impairs the function of vessels in patients with kidney disease

Condition or disease Intervention/treatment Phase
Kidney Disease Drug: Allopurinol Other: Placebo Not Applicable

Detailed Description:

The purpose of the study is to understand the effect of lowering serum uric acid levels on vascular function in individuals with chronic kidney disease by comparing the effects of:

1) Allopurinol therapy and 2) Placebo.

Patients will receive: 3 month study drug (either allopurinol or placebo), with assessment of serum uric acid levels and vascular function.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic Kidney Disease?
Study Start Date : October 2010
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Control
Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.
Other: Placebo
Placebo tablets with no active ingredient
Active Comparator: Allopurinol
Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.
Drug: Allopurinol
Xanthine oxidase inhibitor- effective at lowering uric acid levels.
Other Name: Zyloprim, Allohexal, Allosig, Milurit, Alloril, Progout, Zyloric.



Primary Outcome Measures :
  1. Change in Endothelial Dependent Dilation From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ]
    Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12


Secondary Outcome Measures :
  1. Change in C-reactive Protein From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ]
  2. Change in Serum Interleukin-6 From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ]
  3. Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ]
  4. Change in Oxidized Low Density Lipoprotein From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ]

Other Outcome Measures:
  1. Change in Serum Uric Acid Levels From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ]
    Serum uric acid levels were measured both at baseline and after 12 weeks



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals with moderate chronic kidney disease (CKD stage III) with estimated glomerular filtration rates between 30-60 mL/min/ 1.73m2
  • Elevated uric acid levels
  • Age range: more than 18 years old
  • Ability to give informed consent
  • Albumin > 3.0 g/dL
  • BMI < 40 kg/m2

Exclusion Criteria:

  • Life expectancy < 1.0 years
  • Expected to undergo living related kidney transplant in 6 months
  • Pregnant, breast feeding, or unwilling to use adequate birth control
  • History of severe liver disease
  • History of severe congestive heart failure
  • History of hospitalizations within 3 months
  • Active infection, on antibiotics
  • History of Warfarin Use or other medications that are contraindicated with allopurinol
  • Uncontrolled hypertension
  • History of acute gout on Allopurinol
  • History of adverse reaction to Allopurinol
  • Immunosuppressive therapy within the last 1 yr

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228903


Locations
United States, Colorado
University of Colorado at Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Diana Jalal, MD University of Colorado, Denver

Additional Information:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01228903     History of Changes
Other Study ID Numbers: 10-0625
K23DK088833 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2010    Key Record Dates
Results First Posted: February 23, 2017
Last Update Posted: June 28, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available to investigators upon request from the PI

Keywords provided by University of Colorado, Denver:
uric acid kidney disease endothelial dysfunction

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Allopurinol
Uric Acid
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs