Vascular Risk After Kidney Transplantation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jennifer Larsen, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00374595
First received: September 8, 2006
Last updated: June 18, 2012
Last verified: June 2012

September 8, 2006
June 18, 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

Observational
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.
 
Completed
342
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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00374595
053-95-FB, 1 RO1 DK069919-01A2
Yes
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP