Clinical trial NCT00365833: CEC/EPC and Cardiovascular Risk in Renal Transplant Recipients
Official title: Circulating Endothelial Cell and Endothelial Progenitor Cell Evaluation of Kidney Transplant Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Transplantation, Kidney
Cardiovascular Abnormalities
Cardiovascular Diseases
Keywords: Transplantation
Cardiovascular
Renal
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2006-08-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: de novo renal transplant recipients

Brief summary: 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.

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 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

Primary outcomes:
measure: Cardiovascular Risk Profile
timeFrame: 24 months
Secondary outcomes:
measure: Rate of Cardiovascular Events Post-Transplant
timeFrame: 24 months
measure: Rate of Patient Survival Post-Transplant
timeFrame: 24 months
measure: Rate of Graft Survival Post-Transplant
timeFrame: 24 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Herwig-Ulf Meier-Kriesche, md
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Giselle Guerra, MD
role: PRINCIPAL_INVESTIGATOR
References: