Trial Outcomes & Findings for Mechanisms of Chronic Kidney Disease (CKD)-Induced Foam Cell Formation (NCT NCT01671605)

NCT ID: NCT01671605

Last Updated: 2017-04-21

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 103 participants
• Primary outcome timeframe: Once, at enrollment
• Results posted on: 2017-04-21

Participant Flow

Participant milestones

Measure	CKD Not on Dialysis Patients with CKD not on dialysis (CKD III-IV)	Controls Controls with normal kidney function (Control)
Overall Study STARTED	72	31
Overall Study COMPLETED	72	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	CKD Not on Dialysis n=72 Participants Patients with CKD not on dialysis (CKD III-IV)	Controls n=31 Participants Controls with normal kidney function (Control)	Total n=103 Participants Total of all reporting groups
Age, Continuous	61.9 years STANDARD_DEVIATION 13.5 • n=5 Participants	49.9 years STANDARD_DEVIATION 10.6 • n=7 Participants	55.9 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	20 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	11 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	1 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	56 Participants n=5 Participants	29 Participants n=7 Participants	85 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants	31 participants n=7 Participants	103 participants n=5 Participants
HDL Function	20.8 Percentage n=5 Participants	26.5 Percentage n=7 Participants	23.65 Percentage n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	CKD Not on Dialysis n=72 Participants Patients with CKD not on dialysis (CKD III-IV)	Controls n=31 Participants Controls with normal kidney function (Control)
In Vitro Lipoprotein Functions	20.8 Percentage of cholesterol content Interval 16.1 to 23.7	26.5 Percentage of cholesterol content Interval 19.6 to 28.5

Adverse Events

CKD Not on Dialysis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Valentina Kon

Vanderbilt University Medical Center

Phone: 6153224883

Email: valentina.kon@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place