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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02133534
Recruitment Status : Terminated (failure to enroll)
First Posted : May 8, 2014
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease High Cholesterol Drug: Atorvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Atorvastatin on Endothelial Cell Dysfunction in Chronic Kidney Disease
Study Start Date : February 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: Atorvastatin
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.
Drug: Atorvastatin
Other Name: Lipitor

Primary Outcome Measures :
  1. Improved Counts of Endothelial Progenitor Cells [ Time Frame: baseline, 30 days ]
    Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02133534

Sponsors and Collaborators
Duke University
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Principal Investigator: Lynda Szczech, MD Duke University

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Responsible Party: Duke University Identifier: NCT02133534    
Other Study ID Numbers: Pro00011172
First Posted: May 8, 2014    Key Record Dates
Results First Posted: July 3, 2014
Last Update Posted: July 3, 2014
Last Verified: June 2014
Keywords provided by Duke University:
Chronic kidney disease
High cholesterol
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors