NCT00365833

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

September 30, 2011

Status Verified

September 1, 2011

Enrollment Period

7 months

First QC Date

August 17, 2006

Last Update Submit

September 28, 2011

Conditions

Transplantation, KidneyCardiovascular AbnormalitiesCardiovascular Diseases

Keywords

TransplantationCardiovascularRenal

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular Risk Profile

    Cardiovascular Risk Profile is defined by calculated Framingham Model

    24 months

Secondary Outcomes (3)

  • Rate of Cardiovascular Events Post-Transplant

    24 months

  • Rate of Patient Survival Post-Transplant

    24 months

  • Rate of Graft Survival Post-Transplant

    24 months

Study Arms (1)

Recipients of Kidney Transplant

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

de novo renal transplant recipients

You may qualify if:

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

You may not qualify if:

  • inability to return for follow-up visits
  • multiple organ transplant other than listed above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Cardiovascular AbnormalitiesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Congenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Herwig-Ulf Meier-Kriesche, md

    University of Florida

    PRINCIPAL INVESTIGATOR

  • Giselle Guerra, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 18, 2006

Study Start

July 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

September 30, 2011

Record last verified: 2011-09

Locations

US(1)