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Uric Acid and the Endothelium in CKD

Primary Purpose

Kidney Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Allopurinol

Placebo

About this trial

This is an interventional treatment trial for Kidney Disease focused on measuring uric acid kidney disease endothelial dysfunction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Colorado at Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Allopurinol

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Endothelial Dependent Dilation From Baseline to Week 12

Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12

Secondary Outcome Measures

Change in C-reactive Protein From Baseline to Week 12

Change in Serum Interleukin-6 From Baseline to Week 12

Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12

Change in Oxidized Low Density Lipoprotein From Baseline to Week 12

Full Information

NCT ID

NCT01228903

First Posted

October 25, 2010

Last Updated

June 9, 2017

Sponsor

University of Colorado, Denver

Collaborators

National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT01228903

Brief Title

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

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Disease

Keywords

uric acid kidney disease endothelial dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Arm Title

Allopurinol

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Allopurinol

Other Intervention Name(s)

Zyloprim, Allohexal, Allosig, Milurit, Alloril, Progout, Zyloric.

Intervention Description

Xanthine oxidase inhibitor- effective at lowering uric acid levels.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo tablets with no active ingredient

Primary Outcome Measure Information:

Title

Change in Endothelial Dependent Dilation From Baseline to Week 12

Description

Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

Change in C-reactive Protein From Baseline to Week 12

Time Frame

Baseline and 12 weeks

Title

Change in Serum Interleukin-6 From Baseline to Week 12

Time Frame

Baseline and 12 weeks

Title

Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12

Time Frame

Baseline and 12 weeks

Title

Change in Oxidized Low Density Lipoprotein From Baseline to Week 12

Time Frame

Baseline and 12 weeks

Other Pre-specified Outcome Measures:

Title

Change in Serum Uric Acid Levels From Baseline to Week 12

Description

Serum uric acid levels were measured both at baseline and after 12 weeks

Time Frame

Baseline and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diana Jalal, MD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado at Denver

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified data will be made available to investigators upon request from the PI

Citations:

PubMed Identifier

32964203

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.

Results Reference

derived

Links:

URL

http://www.drugs.com/pro/allopurinol.html

Description

Official information for Allopurinol

URL

http://www.ucdenver.edu/academics/colleges/medicalschool/departments/pediatrics/research/programs/ctrc/Pages/CTRC.aspx

Description

Information about the Recruiting Center

URL

http://en.wikipedia.org/wiki/Endothelium

Description

What is the endothelium?

URL

http://www.kidney.org/kidneydisease/ckd/index.cfm

Description

Facts about Kidney Disease

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Uric Acid and the Endothelium in CKD

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