Overview

This trial is active, not recruiting.

Condition kidney disease
Treatments allopurinol, placebo
Sponsor University of Colorado, Denver
Collaborator National Institutes of Health (NIH)
Start date October 2010
End date September 2016
Trial size 80 participants
Trial identifier NCT01228903, 10-0625, K23DK088833

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
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
Placebo tablets with no active ingredient
(Active Comparator)
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.
allopurinol Zyloprim, Allohexal, Allosig, Milurit, Alloril, Progout, Zyloric.
Xanthine oxidase inhibitor- effective at lowering uric acid levels.

Primary Outcomes

Measure
Endothelial Dependent Dilation
time frame: 12 weeks

Secondary Outcomes

Measure
Systemic inflammation and oxidative stress
time frame: 12 weeks
Inflammation and oxidative stress in the endothelial cells
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.