Trial Outcomes & Findings for Vascular Risk After Kidney Transplantation (NCT NCT00374595)

Last Updated: 2023-10-02

Results Overview

CIMT was defined by ultrasound. The mean and standard error of a 3 year change in CIMT was assessed (between baseline and three year follow up).

Recruitment status

COMPLETED

Target enrollment

338 participants

Primary outcome timeframe

3 years (baseline and three year follow up)

Results posted on

2023-10-02

Participant milestones
Measure	Kidney Transplant Recipients This observational study evaluated nontraditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over time. The study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intima media thickness.
Overall Study STARTED	338
Overall Study COMPLETED	268
Overall Study NOT COMPLETED	70

Reasons for withdrawal
Measure	Kidney Transplant Recipients This observational study evaluated nontraditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over time. The study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intima media thickness.
Overall Study Death	23
Overall Study Withdrawal by Subject	39
Overall Study Lost to Follow-up	3
Overall Study too much time commitment	1
Overall Study transfer care to other clinical site	1
Overall Study relocation	3

Vascular Risk After Kidney Transplantation

Baseline characteristics by cohort
Measure	Kidney Transplant Recipients n=338 Participants This observational study evaluated nontraditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over time. The study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intima media thickness.
Age, Continuous	52.3 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	147 Participants n=5 Participants
Sex: Female, Male Male	191 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	325 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	31 Participants n=5 Participants
Race (NIH/OMB) White	300 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

Timeframe: 3 years (baseline and three year follow up)

Population: 264 participants had 3 year follow-up for Carotid intima media thickness.

CIMT was defined by ultrasound. The mean and standard error of a 3 year change in CIMT was assessed (between baseline and three year follow up).

Outcome measures
Measure	Kidney Transplant Recipients n=264 Participants This observational study evaluated nontraditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over time. The study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intima media thickness.
Carotid Intima Media Thickness (CIMT)	0.044 millimeters (mm) Standard Error 0.006

Serious events: 0 serious events

Other events: 0 other events

Deaths: 23 deaths

Adverse event data not reported

Adverse event data not reported

University of Nebraska Medical Center

Phone: (402) 559-4837