This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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: January 3, 2017
Last verified: January 2017
Results First Received: October 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Condition: Kidney Disease
Interventions: Drug: Allopurinol
Other: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Placebo: Placebo tablets with no active ingredient

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.

Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels.


Participant Flow:   Overall Study
    Control   Allopurinol
STARTED   41   39 
COMPLETED   36   34 
NOT COMPLETED   5   5 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Placebo: Placebo tablets with no active ingredient

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.

Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels.

Total Total of all reporting groups

Baseline Measures
   Control   Allopurinol   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   39   80 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.9  (9.3)   55.9  (13.7)   57.4  (11.5) 
Gender 
[Units: Participants]
Count of Participants
     
Female      9  22.0%      7  17.9%      16  20.0% 
Male      32  78.0%      32  82.1%      64  80.0% 
Region of Enrollment 
[Units: Participants]
     
United States   41   39   80 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Endothelial Dependent Dilation From Baseline to Week 12   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Change in CRP From Baseline to Week 12   [ Time Frame: Baseline and 12 weeks ]

3.  Secondary:   Change in Serum IL-6 From Baseline to Week 12   [ Time Frame: Baseline and 12 weeks ]

4.  Secondary:   Change in MCP-1 From Baseline to Week 12   [ Time Frame: Baseline and 12 weeks ]

5.  Secondary:   Change in OxLDL From Baseline to Week 12   [ Time Frame: Baseline and 12 weeks ]

6.  Other Pre-specified:   Change in Serum Uric Acid Levels From Baseline to Week 12   [ Time Frame: Baseline and 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Diana Jalal
Organization: University of Colorado
phone: 3037244867
e-mail: diana.jalal@ucdenver.edu



Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01228903     History of Changes
Other Study ID Numbers: 10-0625
K23DK088833 ( US NIH Grant/Contract Award Number )
Study First Received: October 25, 2010
Results First Received: October 24, 2016
Last Updated: January 3, 2017