Uric Acid and the Endothelium is CKD

Kidney Disease Clinical Trial

Official title:

Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic Kidney Disease?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01228903
• Other study ID #: 10-0625
• Secondary ID: K23DK088833
• Status: Active, not recruiting
• Phase: N/A
• First received: October 25, 2010
• Last updated: October 12, 2015
• Start date: October 2010
• Est. completion date: September 2016

Study information

• Verified date: October 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will test the hypothesis that uric acid impairs the function of vessels in patients with kidney disease

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Individuals with moderate chronic kidney disease (CKD stage III) with estimated glomerular filtration rates between 30-60 mL/min/ 1.73m2

• Elevated uric acid levels

• Age range: more than 18 years old

• Ability to give informed consent

• Albumin > 3.0 g/dL

• BMI < 40 kg/m2

Exclusion Criteria:

• Life expectancy < 1.0 years

• Expected to undergo living related kidney transplant in 6 months

• Pregnant, breast feeding, or unwilling to use adequate birth control

• History of severe liver disease

• History of severe congestive heart failure

• History of hospitalizations within 3 months

• Active infection, on antibiotics

• History of Warfarin Use or other medications that are contraindicated with allopurinol

• Uncontrolled hypertension

• History of acute gout on Allopurinol

• History of adverse reaction to Allopurinol

• Immunosuppressive therapy within the last 1 yr

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases

Intervention

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

Other:
• Placebo
Placebo tablets with no active ingredient

Locations

Country	Name	City	State
United States	University of Colorado at Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Dependent Dilation	Endothelial Dependent Dilation measured by Flow Mediated Dilation	12 weeks	No
Secondary	Systemic inflammation and oxidative stress	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.	12 weeks	No
Secondary	Inflammation and oxidative stress in the endothelial cells	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).	12 weeks	No

External Links

•   Facts about Kidney Disease
•   Information about the Recruiting Center
•   Official information for Allopurinol
•   What is the endothelium?