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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01671605

First Posted: August 23, 2012

Last Update Posted: April 21, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

Valentina Kon, Vanderbilt University

Purpose

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.

Condition
Chronic Kidney Disease Cardiovascular Disease


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Retrospective
Official Title:	Mechanisms of CKD-Induced Foam Cell Formation

Resource links provided by NLM:

MedlinePlus related topics: Kidney Diseases

U.S. FDA Resources

Further study details as provided by Valentina Kon, Vanderbilt University:

Primary Outcome Measures:

In Vitro Lipoprotein Functions [ Time Frame: Once, at enrollment ]
Cholesterol efflux. Baseline and outcome measurements are the same. The cholesterol efflux was measured once using HDL isolated from CKD and control patients. There was no intervention,this assessment was performed once in each group. The measurement of cholesterol efflux is performed by an in vitro assay in cultured cells. Cells are loaded with cholesterol and maintained for 72 hours. The media of the cultured cells is then changed and the new media contains HDL from CKD or control patients. In additional cells, no HDL is added. The cells are maintained for 24 hours, and intracellular cholesterol is assessed. The cholesterol efflux represents the amount of cholesterol that was leached by HDL from each of our study groups. Thus, cells not exposed to any HDL will contain the highest intracellular cholesterol content. The amount of cholesterol in cells exposed to CKD HDL or control HDL reflects the efflux capacity of that HDL. This is expressed as percent of cholesterol removed by HDL.


Enrollment:	103
Study Start Date:	February 2013
Study Completion Date:	April 2015
Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts
CKD not on dialysis Patients with CKD not on dialysis (CKD III-IV)
Controls Controls with normal kidney function (Control)

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Controls with normal kidney function (Control)

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671605

Locations


United States, Tennessee
Vanderbilt Outpatient Dialysis Center
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University Medical Center

Merck Sharp & Dohme Corp.

Investigators


Principal Investigator:	Valentina Kon, MD	Vanderbilt University Medical Center

More Information


Responsible Party:	Valentina Kon, Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT01671605 History of Changes
Other Study ID Numbers:	090846
First Submitted:	August 20, 2012
First Posted:	August 23, 2012
Results First Submitted:	November 22, 2016
Results First Posted:	April 21, 2017
Last Update Posted:	April 21, 2017
Last Verified:	March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:


Cardiovascular Diseases Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency

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