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CEC/EPC and Cardiovascular Risk in Renal Transplant Recipients (CEC)

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ClinicalTrials.gov Identifier: NCT00365833
Recruitment Status : Terminated (difficulty obtaining required data)
First Posted : August 18, 2006
Last Update Posted : September 30, 2011
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date August 17, 2006
First Posted Date August 18, 2006
Last Update Posted Date September 30, 2011
Study Start Date July 2006
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 28, 2011)
Cardiovascular Risk Profile [ Time Frame: 24 months ]
Cardiovascular Risk Profile is defined by calculated Framingham Model
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00365833 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 28, 2011)
  • Rate of Cardiovascular Events Post-Transplant [ Time Frame: 24 months ]
    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 ]
    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 ]
    Measured by Kaplan-Meier analysis and Cox Proportional Hazard Models to correlate CEC and EPC to this outcome.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CEC/EPC and Cardiovascular Risk in Renal Transplant Recipients
Official Title Circulating Endothelial Cell and Endothelial Progenitor Cell Evaluation of Kidney Transplant Patients
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population de novo renal transplant recipients
Condition
  • Transplantation, Kidney
  • Cardiovascular Abnormalities
  • Cardiovascular Diseases
Intervention Not Provided
Study Groups/Cohorts Recipients of Kidney Transplant
Patients Transplanted with Live or Deceased Donor's Kidney. Standard of Care treatment pre- and post-transplant.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 4, 2008)
8
Original Enrollment
 (submitted: August 17, 2006)
40
Actual Study Completion Date February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00365833
Other Study ID Numbers 217-2006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Florida
Study Sponsor University of Florida
Collaborators Not Provided
Investigators
Principal Investigator: Herwig-Ulf Meier-Kriesche, md University of Florida
Principal Investigator: Giselle Guerra, MD University of Florida
PRS Account University of Florida
Verification Date September 2011