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Uric Acid and the Endothelium in CKD

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01228903
First received: October 25, 2010
Last updated: June 9, 2017
Last verified: May 2017
October 25, 2010
June 9, 2017
October 2010
September 2016   (Final data collection date for primary outcome measure)
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
Endothelial Dependent Dilation [ Time Frame: 12 weeks ]
Endothelial Dependent Dilation measured by Flow Mediated Dilation
Complete list of historical versions of study NCT01228903 on ClinicalTrials.gov Archive Site
  • Change in C-reactive Protein From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ]
  • Change in Serum Interleukin-6 From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ]
  • Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ]
  • Change in Oxidized Low Density Lipoprotein From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ]
  • 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 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).
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
Not Provided
 
Uric Acid and the Endothelium in 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
Intervention Model: Parallel Assignment
Masking: Participant, 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.
 
Completed
80
September 2016
September 2016   (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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01228903
10-0625
K23DK088833 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available to investigators upon request from the PI
University of Colorado, Denver
University of Colorado, Denver
  • National Institutes of Health (NIH)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Diana Jalal, MD University of Colorado, Denver
University of Colorado, Denver
May 2017

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