Clinical trial NCT01228903: Uric Acid and the Endothelium in CKD
Official title: Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic Kidney Disease?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Disease
Keywords: uric acid kidney disease endothelial dysfunction
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-10-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Endothelial Dependent Dilation From Baseline to Week 12
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in C-reactive Protein From Baseline to Week 12
timeFrame: Baseline and 12 weeks
measure: Change in Serum Interleukin-6 From Baseline to Week 12
timeFrame: Baseline and 12 weeks
measure: Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12
timeFrame: Baseline and 12 weeks
measure: Change in Oxidized Low Density Lipoprotein From Baseline to Week 12
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Change in Serum Uric Acid Levels From Baseline to Week 12
timeFrame: Baseline and 12 weeks
Locations:
city: Aurora
country: United States
facility: University of Colorado at Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Diana Jalal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perrenoud L, Kruse NT, Andrews E, You Z, Chonchol M, Wu C, Ten Eyck P, Zepeda-Orozco D, Jalal D. Uric Acid Lowering and Biomarkers of Kidney Damage in CKD Stage 3: A Post Hoc Analysis of a Randomized Clinical Trial. Kidney Med. 2020 Feb 26;2(2):155-161. doi: 10.1016/j.xkme.2019.11.007. eCollection 2020 Mar-Apr.