Uric Acid and the Endothelium in CKD

NCT ID: NCT01228903

Last Updated: 2017-06-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablets with no active ingredient

Allopurinol

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.

Group Type ACTIVE_COMPARATOR

Allopurinol

Intervention Type DRUG

Xanthine oxidase inhibitor- effective at lowering uric acid levels.

Interventions

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Allopurinol

Xanthine oxidase inhibitor- effective at lowering uric acid levels.

Intervention Type DRUG

Placebo

Placebo tablets with no active ingredient

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diana Jalal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado at Denver

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32964203 (View on PubMed)

Related Links

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Other Identifiers

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K23DK088833

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10-0625

Identifier Type: -

Identifier Source: org_study_id

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