Vascular Risk After Kidney Transplantation

NCT ID: NCT00374595

Last Updated: 2023-10-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

338 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2023-06-20

Brief Summary

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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

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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

Conditions

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Cardiovascular Disease Chronic Kidney Disease Diabetes Vitamin D Deficiency Hyperparathyroidism

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer L Larsen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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1R01DK069919-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0053-95-FB

Identifier Type: -

Identifier Source: org_study_id

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