Uric Acid and the Endothelium is CKD
Recruitment status was Active, not recruiting
This study will test the hypothesis that uric acid impairs the function of vessels in patients with kidney disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic Kidney Disease?|
- Endothelial Dependent Dilation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Endothelial Dependent Dilation measured by Flow Mediated Dilation
- Systemic inflammation and oxidative stress [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Inflammation will be measured by plasma levels of the following: hs- CRP, interleukin 6 (IL-6), and monocyte chemotactic protein-1 (MCP-1). Oxidized low density lipoprotein cholesterol (oxLDL), asymmetric dimethylarginine (ADMA), and 8-isoprostanes, as markers of oxidative stress.
- Inflammation and oxidative stress in the endothelial cells [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Actual measurements: intercellular adhesion molecule (ICAM-1) and nuclear factor kappa-B (NFkappa-B p65), nitrotyrosine, Nox4-containing NAD(P)H oxidase complexes, and endothelial nitric oxide synthase (eNOS).
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228903
|United States, Colorado|
|University of Colorado at Denver|
|Aurora, Colorado, United States, 80045|