Uric Acid and the Endothelium in CKD

NCT01228903 | Completed Results DMC

• 2 other identifiers: 10-0625K23DK088833
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kidney Disease

Keywords

uric acid kidney disease endothelial dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 12 weeks

Secondary Outcomes (4)

• Change in C-reactive Protein From Baseline to Week 12

  Baseline and 12 weeks

• Change in Serum Interleukin-6 From Baseline to Week 12

  Baseline and 12 weeks

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

  Baseline and 12 weeks

• Change in Oxidized Low Density Lipoprotein From Baseline to Week 12

  Baseline and 12 weeks

Other Outcomes (1)

• Change in Serum Uric Acid Levels From Baseline to Week 12

  Baseline and 12 weeks

Study Arms (2)

Control

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.

Other: Placebo

Allopurinol

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.

Drug: Allopurinol

Interventions

Allopurinol DRUG

Xanthine oxidase inhibitor- effective at lowering uric acid levels.

Also known as: Zyloprim, Allohexal, Allosig, Milurit, Alloril, Progout, Zyloric.

Allopurinol

Placebo OTHER

Placebo tablets with no active ingredient

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Colorado at Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 32964203 DERIVED

Related Links

• What is the endothelium?

MeSH Terms

Conditions

Kidney Diseases

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Diana Jalal
• Organization: University of Colorado

diana.jalal@ucdenver.edu

3037244867

Study Officials

• Diana Jalal, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 27, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 28, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)