Mechanisms of Chronic Kidney Disease (CKD)-Induced Foam Cell Formation
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ClinicalTrials.gov Identifier: NCT01671605 |
Recruitment Status
:
Completed
First Posted
: August 23, 2012
Results First Posted
: April 21, 2017
Last Update Posted
: April 21, 2017
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Condition or disease |
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Chronic Kidney Disease Cardiovascular Disease |
Study Type : | Observational |
Actual Enrollment : | 103 participants |
Observational Model: | Case-Only |
Time Perspective: | Retrospective |
Official Title: | Mechanisms of CKD-Induced Foam Cell Formation |
Study Start Date : | February 2013 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | April 2015 |

Group/Cohort |
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CKD not on dialysis
Patients with CKD not on dialysis (CKD III-IV)
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Controls
Controls with normal kidney function (Control)
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- 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.

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

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
United States, Tennessee | |
Vanderbilt Outpatient Dialysis Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Valentina Kon, MD | Vanderbilt University Medical Center |
Responsible Party: | Valentina Kon, Principal Investigator, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT01671605 History of Changes |
Other Study ID Numbers: |
090846 |
First Posted: | August 23, 2012 Key Record Dates |
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 |