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

Condition Intervention
Kidney Disease Drug: Allopurinol Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic Kidney Disease?

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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


Enrollment: 80
Study Start Date: October 2010
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Zyloprim, Allohexal, Allosig, Milurit, Alloril, Progout, Zyloric.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228903

Locations
United States, Colorado
University of Colorado at Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Diana Jalal, MD University of Colorado, Denver
  More Information

Additional Information:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01228903     History of Changes
Other Study ID Numbers: 10-0625
K23DK088833 ( U.S. NIH Grant/Contract )
Study First Received: October 25, 2010
Results First Received: October 24, 2016
Last Updated: June 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available to investigators upon request from the PI

Keywords provided by University of Colorado, Denver:
uric acid kidney disease endothelial dysfunction

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Allopurinol
Uric Acid
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2017