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CEC/EPC and Cardiovascular Risk in Renal Transplant Recipients

This study has been terminated.
(difficulty obtaining required data)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00365833
First received: August 17, 2006
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  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
Transplantation, Kidney
Cardiovascular Abnormalities
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating Endothelial Cell and Endothelial Progenitor Cell Evaluation of Kidney Transplant Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Cardiovascular Risk Profile [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Cardiovascular Risk Profile is defined by calculated Framingham Model


Secondary Outcome Measures:
  • Rate of Cardiovascular Events Post-Transplant [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Measured by Kaplan-Meier analysis and Cox Proportional Hazard Models to correlate CEC and EPC to this outcome.

  • Rate of Patient Survival Post-Transplant [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Measured by Kaplan-Meier analysis and Cox Proportional Hazard Models to correlate CEC and EPC to this outcome.

  • Rate of Graft Survival Post-Transplant [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Measured by Kaplan-Meier analysis and Cox Proportional Hazard Models to correlate CEC and EPC to this outcome.


Enrollment: 8
Study Start Date: July 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Recipients of Kidney Transplant
Patients Transplanted with Live or Deceased Donor's Kidney. Standard of Care treatment pre- and post-transplant.

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 (CEC) and a reduction of Endothelial Progenitor Cells (EPC) 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 (End Stage Renal Disease). 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 listed 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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00365833     History of Changes
Other Study ID Numbers: 217-2006
Study First Received: August 17, 2006
Last Updated: September 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Transplantation
Cardiovascular
Renal

Additional relevant MeSH terms:
Congenital Abnormalities
Cardiovascular Diseases
Cardiovascular Abnormalities

ClinicalTrials.gov processed this record on May 16, 2013