Uric Acid and the Endothelium in CKD

June 9, 2017 updated by: University of Colorado, Denver

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado at Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Zyloprim, Allohexal, Allosig, Milurit, Alloril, Progout, Zyloric.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in C-reactive Protein From Baseline to Week 12
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in Serum Interleukin-6 From Baseline to Week 12
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in Oxidized Low Density Lipoprotein From Baseline to Week 12
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

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

Investigators

  • Principal Investigator: Diana Jalal, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 25, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (Estimate)

October 27, 2010

Study Record Updates

Last Update Posted (Actual)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-0625
  • K23DK088833 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made available to investigators upon request from the PI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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