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

NCT02133534 | Terminated Phase 4 Results

• 1 other identifier: Pro00011172
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Disease; High Cholesterol

Keywords

Chronic kidney disease; High cholesterol

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Atorvastatin

EXPERIMENTAL

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

Interventions

Atorvastatin DRUG

Also known as: Lipitor

Atorvastatin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypercholesterolemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Limitations and Caveats

Early termination of trial due to lack of enrollment.

Results Point of Contact

• Title: Research Practice Manager
• Organization: Duke University Medical Center

bixby001@duke.edu

919 681 6819

Study Officials

• Lynda Szczech, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 8, 2014
• Study Start: February 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 3, 2014
• Results First Posted: July 3, 2014

Record last verified: 2014-06