Uric Acid and the Endothelium is CKD

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Colorado, Denver
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01228903
First received: October 25, 2010
Last updated: September 25, 2012
Last verified: September 2012

October 25, 2010
September 25, 2012
October 2010
September 2015   (final data collection date for primary outcome measure)
Endothelial Dependent Dilation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Endothelial Dependent Dilation measured by Flow Mediated Dilation
Same as current
Complete list of historical versions of study NCT01228903 on ClinicalTrials.gov Archive Site
  • Systemic inflammation and oxidative stress [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
  • Systemic inflammation and oxidative stress [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Actual measurements: intercellular adhesion moecule (ICAM-1) and nuclear factor kappa-B (NFkappa-B p65), nitrotyrosine, Nox4-containing NAD(P)H oxidase complexes, and endothelial nitric oxide synthase (eNOS).
Not Provided
Not Provided
 
Uric Acid and the Endothelium is CKD
Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic Kidney Disease?

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Kidney Disease
  • Drug: Allopurinol
    Xanthine oxidase inhibitor- effective at lowering uric acid levels.
    Other Name: Zyloprim, Allohexal, Allosig, Milurit, Alloril, Progout, Zyloric.
  • Other: Placebo
    Placebo tablets with no active ingredient
  • 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.
    Intervention: Other: Placebo
  • 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.
    Intervention: Drug: Allopurinol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Not Provided
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Diana I Jalal, MD 3037244867 diana.jalal@ucdenver.edu
Contact: Michel Chonchol, MD 3033996997 michel.chonchol@ucdenver.edu
United States
 
NCT01228903
10-0625, K23DK088833
Yes
University of Colorado, Denver
University of Colorado, Denver
National Institutes of Health (NIH)
Not Provided
University of Colorado, Denver
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP