Uric Acid and the Endothelium in CKD
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|ClinicalTrials.gov Identifier: NCT01228903|
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : February 23, 2017
Last Update Posted : June 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Kidney Disease||Drug: Allopurinol Other: Placebo||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic Kidney Disease?|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
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.
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.
Xanthine oxidase inhibitor- effective at lowering uric acid levels.
Other Name: Zyloprim, Allohexal, Allosig, Milurit, Alloril, Progout, Zyloric.
- 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
- 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 ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228903
|United States, Colorado|
|University of Colorado at Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Diana Jalal, MD||University of Colorado, Denver|