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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. Identifier: NCT00374595
Recruitment Status : Unknown
Verified March 2018 by Jennifer Larsen, MD, University of Nebraska.
Recruitment status was:  Active, not recruiting
First Posted : September 11, 2006
Last Update Posted : April 2, 2018
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Jennifer Larsen, MD, 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.

Condition or disease
Cardiovascular Disease Chronic Kidney Disease Diabetes Vitamin D Deficiency Hyperparathyroidism

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

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Study Type : Observational
Actual Enrollment : 342 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Vascular Risk After Kidney Transplantation
Study Start Date : April 2006
Estimated Primary Completion Date : March 29, 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Carotid intima media thickness [ Time Frame: 3 years ]
    defined by ultrasound

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Transplant Clinic patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00374595

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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-1230
Sponsors and Collaborators
University of Nebraska
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Jennifer L Larsen, MD University of Nebraska
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Responsible Party: Jennifer Larsen, MD, Vice Chancelor of Research, University of Nebraska Identifier: NCT00374595    
Other Study ID Numbers: 053-95-FB
1R01DK069919-01A2 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Larsen, MD, University of Nebraska:
Kidney Transplant
Vascular Risk
Insulin resistance
Chronic kidney disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Cardiovascular Diseases
Vitamin D Deficiency
Urologic Diseases
Renal Insufficiency
Deficiency Diseases
Nutrition Disorders
Parathyroid Diseases
Endocrine System Diseases