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

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02133534
• Collaborator: (none)
• Enrollment: 1
• Arm: 1
• Duration (Months): 14.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease; High Cholesterol	Drug: Atorvastatin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• 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: Feb 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

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 Names: Lipitor

Outcome Measures

Primary Outcome Measures

1. Improved Counts of Endothelial Progenitor Cells [baseline, 30 days]

   Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Lynda Szczech, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02133534
• Other Study ID Numbers: Pro00011172
• First Posted: May 8, 2014
• Last Update Posted: Jul 3, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Duke University: Chronic kidney disease; High cholesterol
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypercholesterolemia; Atorvastatin

Study Results

Participant Flow

Arm/Group Title	Atorvastatin
Arm/Group 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. Atorvastatin
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Atorvastatin
Arm/Group 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. Atorvastatin
Overall Participants	1
Age, Customized (participants) [Number]
Greater than 18 Years	1 100%
Sex: Female, Male (Count of Participants)
Female	1 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.

Arm/Group Title	Atorvastatin
Arm/Group 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. Atorvastatin
Measure Participants	0

Adverse Events

Time Frame	30 days
Adverse Event Reporting Description	Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.
Arm/Group Title	Atorvastatin
Arm/Group 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. Atorvastatin
All Cause Mortality
	Atorvastatin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Atorvastatin
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Atorvastatin
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

Early termination of trial due to lack of enrollment.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.