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

NCT ID: NCT01671605

Last Updated: 2017-04-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-04-30

Brief 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. 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.

Conditions

Chronic Kidney Disease; Cardiovascular Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

CKD not on dialysis

Patients with CKD not on dialysis (CKD III-IV)

No interventions assigned to this group

Controls

Controls with normal kidney function (Control)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Patients with moderate degree of CKD, or patients with advanced CKD or control subjects with intact kidney function

Male or female

All ethnic groups

≥ 18 years and have signed informed consent

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Valentina Kon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valentina Kon, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt Outpatient Dialysis Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

090846

Identifier Type: -

Identifier Source: org_study_id