Uric Acid and the Endothelium is CKD
|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 2016|
|Estimated Primary Completion Date:||September 2016 (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|