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CEC/EPC and Cardiovascular Risk in Renal Transplant Recipients

NCT ID: NCT00365833

Last Updated: 2011-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-02-28

Brief Summary

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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

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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.

Conditions

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Transplantation, Kidney Cardiovascular Abnormalities Cardiovascular Diseases

Keywords

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Transplantation Cardiovascular Renal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Recipients of Kidney Transplant

Patients Transplanted with Live or Deceased Donor's Kidney. Standard of Care treatment pre- and post-transplant.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herwig-Ulf Meier-Kriesche, md

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Giselle Guerra, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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217-2006

Identifier Type: -

Identifier Source: org_study_id