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CEC/EPC and Cardiovascular Risk in Renal Transplant Recipients
This study has been terminated.
( difficulty obtaining required data )
First Received: August 17, 2006   Last Updated: June 4, 2008   History of Changes
Sponsored by: University of Florida
Information provided by: University of Florida
ClinicalTrials.gov Identifier: NCT00365833
  Purpose

We believe that certain cells in the human body (Circulating Endothelial Cells and Endothelial Progenitor Cells)are related to risk of cardiovascular disease. It may be possible to measure levels of these cells in patients who have had a kidney transplant and predict their risk of developing cardiovascular disease.


Condition
Kidney Transplantation
Cardiovascular Abnormalities
Cardiovascular Diseases

MedlinePlus related topics: Kidney Transplantation
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Circulating Endothelial Cell and Endothelial Progenitor Cell Evaluation of Kidney Transplant Patients

Further study details as provided by University of Florida:

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 8
Study Start Date: July 2006
Estimated Study Completion Date: August 2008
Detailed Description:

Coronary disease is one of the most common causes of morbidity and mortality in patients with known chronic renal insufficiency and those with end stage renal disease. Consequently, early detection with markers such as circulating endothelial cells and endothelial progenitor cells has been studied in order to identify vascular function and assess overall cardiovascular risk. Based on current research, there exists a notable increase in circulating endothelial cells and a reduction of endothelial progenitor cells with renal dysfunction due to endothelial damage. Therefore circulating endothelial cells are a marker for cardiovascular health. Renal transplant patients also possess a higher cardiovascular risk than the general population, but have known improvement in survival as compared to patients with ESRD. In addition, because of the excellent outcomes, graft and patient survival and even acute rejection are no longer very useful endpoints for clinical studies. The tolerability of transplant drug regimens and the impact of these regimes on cardiovascular health in kidney transplantation has become, consequently, a new focus of research. Currently, no clear long-term analysis has been fulfilled analyzing CEC or EPC in this group of patients. We hypothesize that CEC can serve as biological markers for cardiovascular risk assessment in cadaveric and living renal transplant patients. We eventually hope measurement of these cells can serve as an endpoint in determining cardiovascular outcome in renal transplant patients. Our present study is aimed to get an initial assessment of the kinetics of CEC and EPC in renal transplant recipients just prior to transplant and for the first two years post transplant.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

de novo renal transplant recipients

Criteria

Inclusion Criteria:

  • kidney transplant recipients
  • kidney/pancreas transplant recipients
  • age 18-80

Exclusion Criteria:

  • inability to return for follow-up visits
  • multiple organ transplant other than above
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365833

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Herwig-Ulf Meier-Kriesche, md University of Florida
Principal Investigator: Giselle Guerra, MD University of Florida
  More Information

No publications provided

Study ID Numbers: 217-2006
Study First Received: August 17, 2006
Last Updated: June 4, 2008
ClinicalTrials.gov Identifier: NCT00365833     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Transplantation
Cardiovascular
Renal

Study placed in the following topic categories:
Cardiovascular Abnormalities
Congenital Abnormalities

Additional relevant MeSH terms:
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 06, 2009