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Uric Acid and the Endothelium is CKD

This study is ongoing, but not recruiting participants.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: October 25, 2010
Last updated: October 12, 2015
Last verified: October 2015
This study will test the hypothesis that uric acid impairs the function of vessels in patients with kidney disease

Condition Intervention
Kidney Disease
Drug: Allopurinol
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic Kidney Disease?

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Endothelial Dependent Dilation [ Time Frame: 12 weeks ]
    Endothelial Dependent Dilation measured by Flow Mediated Dilation

Secondary Outcome Measures:
  • Systemic inflammation and oxidative stress [ Time Frame: 12 weeks ]
    Inflammation will be measured by plasma levels of the following: hs- CRP, interleukin 6 (IL-6), and monocyte chemotactic protein-1 (MCP-1). Oxidized low density lipoprotein cholesterol (oxLDL), asymmetric dimethylarginine (ADMA), and 8-isoprostanes, as markers of oxidative stress.

  • Inflammation and oxidative stress in the endothelial cells [ Time Frame: 12 weeks ]
    Actual measurements: intercellular adhesion molecule (ICAM-1) and nuclear factor kappa-B (NFkappa-B p65), nitrotyrosine, Nox4-containing NAD(P)H oxidase complexes, and endothelial nitric oxide synthase (eNOS).

Estimated Enrollment: 80
Study Start Date: October 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01228903

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)
  More Information

Additional Information:
Responsible Party: University of Colorado, Denver Identifier: NCT01228903     History of Changes
Other Study ID Numbers: 10-0625  K23DK088833 
Study First Received: October 25, 2010
Last Updated: October 12, 2015

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

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Uric Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers processed this record on February 20, 2017