Uric Acid and the Endothelium in CKD
|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
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|