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The Effect of Atorvastatin on Endothelial Cell Dysfunction in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease, High Cholesterol

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic kidney disease, High cholesterol

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stage 3, 4 and 5 chronic kidney disease (not on dialysis)
  • Hyperlipidemia requiring cholesterol lowering therapy
  • Aged 18 to 80 years old
  • Ability to provide informed consent

Exclusion Criteria:

  • Patients requiring multiple cholesterol reducing agents
  • Patients with neovascularization present, such as neoplasm, active wounds, or significant retinopathy
  • Patients with contraindications or allergy to statins

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Atorvastatin

    Arm Description

    Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.

    Outcomes

    Primary Outcome Measures

    Improved Counts of Endothelial Progenitor Cells
    Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 6, 2014
    Last Updated
    June 3, 2014
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02133534
    Brief Title
    The Effect of Atorvastatin on Endothelial Cell Dysfunction in Chronic Kidney Disease
    Official Title
    The Effect of Atorvastatin on Endothelial Cell Dysfunction in Chronic Kidney Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Terminated
    Why Stopped
    failure to enroll
    Study Start Date
    February 2008 (undefined)
    Primary Completion Date
    May 2009 (Actual)
    Study Completion Date
    May 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to see if patients with chronic kidney disease have endothelial cells that don't function properly, which is thought to be a marker for cardiovascular risk. Endothelial cells line the heart and blood vessels. The investigators will treat your high cholesterol with a cholesterol-lowering drug (atorvastatin, or Lipitor). They will determine if this cholesterol lowering drug improves subjects' cholesterol as well as the function of endothelial cells.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Disease, High Cholesterol
    Keywords
    Chronic kidney disease, High cholesterol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Atorvastatin
    Arm Type
    Experimental
    Arm Description
    Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin
    Other Intervention Name(s)
    Lipitor
    Primary Outcome Measure Information:
    Title
    Improved Counts of Endothelial Progenitor Cells
    Description
    Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells.
    Time Frame
    baseline, 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Stage 3, 4 and 5 chronic kidney disease (not on dialysis) Hyperlipidemia requiring cholesterol lowering therapy Aged 18 to 80 years old Ability to provide informed consent Exclusion Criteria: Patients requiring multiple cholesterol reducing agents Patients with neovascularization present, such as neoplasm, active wounds, or significant retinopathy Patients with contraindications or allergy to statins
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lynda Szczech, MD
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Atorvastatin on Endothelial Cell Dysfunction in Chronic Kidney Disease

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