Uric Acid and the Endothelium in CKD

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Kidney Disease

Treatments: Other: Placebo; Drug: Allopurinol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01228903

10-0625

K23DK088833 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Allopurinol

Active Comparator group

Description:

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.

Treatment:

Drug: Allopurinol