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Uric Acid and the Endothelium in CKD

Not Applicable
Completed
Conditions
Kidney Disease
Interventions
Other: Placebo
Registration Number
NCT01228903
Lead Sponsor
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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ControlPlaceboPatients 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.
AllopurinolAllopurinolPatients 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.
Primary Outcome Measures
NameTimeMethod
Change in Endothelial Dependent Dilation From Baseline to Week 12Baseline and 12 weeks

Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12

Secondary Outcome Measures
NameTimeMethod
Change in C-reactive Protein From Baseline to Week 12Baseline and 12 weeks
Change in Oxidized Low Density Lipoprotein From Baseline to Week 12Baseline and 12 weeks
Change in Serum Interleukin-6 From Baseline to Week 12Baseline and 12 weeks
Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12Baseline and 12 weeks

Trial Locations

Locations (1)

University of Colorado at Denver

🇺🇸

Aurora, Colorado, United States

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