Vascular Risk After Kidney Transplantation

Completed

• Conditions: Cardiovascular Disease; Chronic Kidney Disease; Diabetes; Hyperparathyroidism; Vitamin D Deficiency

• Registration Number: NCT00374595
• Lead Sponsor: University of Nebraska

Brief Summary

Hypothesis: Nontraditional risk factors, such as inflammation, vitamin D deficiency, elevated PTH, insulin resistance, homocysteine, or uric acid, contribute to cardiovascular disease progression after kidney transplant.

The purpose of this study is to evaluate which traditional and nontraditional cardiovascular disease risk factors best predict progression of cardiovascular disease (CVD) using carotid intima media thickness performed by ultrasound, in kidney transplant patients.

Detailed Description

Cardiovascular disease remains the greatest cause of mortality after kidney transplant. Traditional risk factors, such as hypertension, diabetes, hyperlipidemia and smoking, contribute to vascular disease after transplant, but nontraditional risk factors may play a bigger role in vascular disease progression in this setting. This observational study will evaluate 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

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-09-08
• Study First Submitted QC: 2006-09-08
• Study First Posted: 2006-09-11
• Primary Completion: 2012-07-26
• Results First Submitted: 2023-06-19
• Study Completion: 2023-06-20
• Results First Submitted QC: 2023-08-08
• Results First Posted: 2023-08-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

• Kidney transplant more than 6 months ago
• 19 years or older

Exclusion Criteria

• Estimated GFR <30
• Previous small bowel, or lung transplant
• Pancreas transplant less than 6 months ago
• Cancer or any condition that would change weight dramatically in the near future such as malabsorption.
• Willing to return for testing annually for 3 years
• Women who are pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Carotid Intima Media Thickness (CIMT)	3 years (baseline and three year follow up)	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).

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States