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Vascular Risk After Kidney Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00374595
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : June 19, 2012
Information provided by (Responsible Party):

September 8, 2006
September 11, 2006
June 19, 2012
April 2006
June 2012   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00374595 on ClinicalTrials.gov Archive Site
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Vascular Risk After Kidney Transplantation
Vascular Risk After Kidney Transplantation

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.

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
Time Perspective: Prospective
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Probability Sample
Transplant Clinic patients
  • Cardiovascular Disease
  • Chronic Kidney Disease
  • Diabetes
  • Vitamin D Deficiency
  • Hyperparathyroidism
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
1R01DK069919-01A2 ( U.S. NIH Grant/Contract )
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Jennifer Larsen, MD, University of Nebraska
University of Nebraska
National Institutes of Health (NIH)
Principal Investigator: Jennifer L Larsen, MD University of Nebraska
University of Nebraska
June 2012