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
  Purpose

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
Cardiovascular Disease
Chronic Kidney Disease
Diabetes
Vitamin D Deficiency
Hyperparathyroidism

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Vascular Risk After Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Enrollment: 342
Study Start Date: April 2006
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Transplant Clinic patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374595

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-1230
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Jennifer L Larsen, MD University of Nebraska
  More Information

No publications provided

Responsible Party: Jennifer Larsen, MD, Vice Chancelor of Research, University of Nebraska
ClinicalTrials.gov Identifier: NCT00374595     History of Changes
Other Study ID Numbers: 053-95-FB, 1 RO1 DK069919-01A2
Study First Received: September 8, 2006
Last Updated: June 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Kidney Transplant
Vascular Risk
inflammation
Diabetes
Insulin resistance
Chronic kidney disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperparathyroidism
Kidney Diseases
Renal Insufficiency, Chronic
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Endocrine System Diseases
Malnutrition
Nutrition Disorders
Parathyroid Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014