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NCT02133534 Clinical Trial

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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02133534
Other study ID # Pro00011172
Secondary ID
Status Terminated
Phase Phase 4
First received May 6, 2014
Last updated June 3, 2014
Start date February 2008
Est. completion date May 2009

Study information
Verified date June 2014
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Outcome
Type Measure Description Time frame Safety issue
Primary Improved Counts of Endothelial Progenitor Cells Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells. baseline, 30 days No
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