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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Valentina Kon, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01671605
First received: August 20, 2012
Last updated: September 29, 2014
Last verified: September 2014
  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 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.


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:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • In vitro lipoprotein functions [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
ESRD on hemodialysis
Patients with ESRD on hemodialysis(CKD stage V) (ESRD-HD)
CKD not on dialysis
Patients with CKD not on dialysis (CKD III-IV)
Controls
Controls with normal kidney function (Control)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with ESRD on hemodialysis (CKD stage V) (ESRD-HD)

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 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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01671605

Locations
United States, Tennessee
Vanderbilt Outpatient Dialysis Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Valentina Kon, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Valentina Kon, Principal Investigatro, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01671605     History of Changes
Other Study ID Numbers: 090846
Study First Received: August 20, 2012
Last Updated: September 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on November 24, 2014