Mechanisms of Chronic Kidney Disease (CKD)-Induced Foam Cell Formation

Cardiovascular Disease Clinical Trial

Official title:

Mechanisms of CKD-Induced Foam Cell Formation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671605
• Other study ID #: 090846
• Status: Completed
• Phase: N/A
• First received: August 20, 2012
• Last updated: April 1, 2015
• Start date: February 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

There is currently little understanding of macrophage cholesterol homeostasis and foam cell formation across the spectrum of CKD. We hypothesize that an inverse relationship exist between the severity of CKD and processes underlying foam cell formation, and that the relationship becomes independent of serum lipoprotein levels as renal function declines. We propose to systematically examine scavenger receptors and cholesterol uptake as well as cholesterol transporters and efflux mechanisms in individuals with normal renal function, patients with moderate CKD and those with ESRD-HD. We further propose to determine if processed contributing to foam cell formation are related to the plasma lipid profile and if the relationship is modified by co-morbidities, such as diabetes, obesity, systemic inflammation which are common in this population and directly influence vascular integrity. These data will be critically important to understand when the abnormality starts and will provide crucial information.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with moderate degree of CKD, or patients with advanced CKD who have progressed to ESRD requiring maintenance dialysis, or control subjects with intact kidney function

Male or female

All ethnic groups

= 18 years and have signed informed consent

For ESRD-HD subjects: > 6 months of hemodialysis

Exclusion Criteria:

Pregnancy and current smoking

BMI > 45

Rheumatoid arthritis and systemic lupus erythematosus

History of active or chronic hepatitis B, history of active or chronic hepatitis C, human immunodeficiency virus (HIV)

For moderate CKD subjects: nephrotic syndrome

For control subjects: nephrotic syndrome, patients with estimated GFR < 60 mL/min/1.73 m^2, or proteinuria

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	Vanderbilt Outpatient Dialysis Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In vitro lipoprotein functions		one year	No