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Trial record 80 of 530 for:    stem cell kidney

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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Kidney Disease
High Cholesterol
Intervention Drug: Atorvastatin
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Atorvastatin
Hide 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
Arm/Group Title Atorvastatin
Hide 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 Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Greater than 18 Years Number Analyzed 1 participants
1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Improved Counts of Endothelial Progenitor Cells
Hide Description Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells.
Time Frame baseline, 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.
Arm/Group Title Atorvastatin
Hide 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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
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
Hide 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 (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Atorvastatin
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atorvastatin
Affected / at Risk (%)
Total   0/0 
Early termination of trial due to lack of enrollment.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Research Practice Manager
Organization: Duke University Medical Center
Phone: 919 681 6819
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02133534     History of Changes
Other Study ID Numbers: Pro00011172
First Submitted: May 6, 2014
First Posted: May 8, 2014
Results First Submitted: June 3, 2014
Results First Posted: July 3, 2014
Last Update Posted: July 3, 2014