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Completed

NCT Number: NCT01228903

Uric Acid and the Endothelium in CKD

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

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Key information

Conditions

Kidney Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado at Denver

Aurora, Colorado, 80045, United States

About this study

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:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allopurinol

Drug

Xanthine oxidase inhibitor- effective at lowering uric acid levels.

Other names: Zyloprim, Allohexal, Allosig, Milurit, Alloril, Progout, Zyloric.

Placebo

Other

Placebo tablets with no active ingredient

Primary outcomes

  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 outcomes

  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 outcomes

  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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Official study title

Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic Kidney Disease?

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2010
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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