Endothelial Microparticles: A Novel Marker of Vascular Dysfunction

February 26, 2018 updated by: University of Colorado, Denver
The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment with calcineurin inhibitors (CNIs) are each associated with the release of endothelial microparticles into the plasma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment with calcineurin inhibitors (CNIs) are each associated with the release of endothelial microparticles into the plasma. These injury-associated microparticles have a different molecular/protein composition than those released from endothelial cells in healthy patients, and their abundance correlates with vascular injury. To test this hypothesis the investigators propose a 3 arm case-controlled study including normal controls, individuals with stage III and IV CKD not receiving CNI therapy, and individuals with stage III and IV CKD post kidney transplantation receiving a CNI. The goal of this study is to measure the amount of microparticles in patients with kidney disease who have had a kidney transplant. Another goal of this study is to see if the measurements of microparticles are related to poor function of the vessels (endothelial dysfunction).

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado School of Medicine
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus; CTRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

90 volunteers from the Anschutz Medical Campus

Description

Inclusion Criteria:

For Healthy controls:

  • BMI less than 40 kg/m^2
  • Able to give informed consent

For Stage III or IV CKD patients:

  • BMI less than 40 kg/m^2
  • Able to give informed consent
  • An estimated Glomerular-Filtration Rate (GFR) of 20-60 mL/min/1.73m^2

For Post-kidney transplant and stage III or IV CKD patients:

  • BMI less than 40 kg/m^2
  • Able to give informed consent
  • An estimated Glomerular-Filtration Rate (GFR) of 20-60 mL/min/1.73m^2

Exclusion Criteria:

For Healthy controls:

-Women pregnant or breastfeeding

For Stage III or IV CKD patients:

  • Women pregnant or breastfeeding
  • Adults with a life expectancy of less than one year
  • A history of significant liver disease or congestive heart failure
  • Hospitalization within the last three months
  • Active infection on antibiotic therapy
  • Uncontrolled hypertension (>140/90)
  • Immunosuppressive therapy within the last year

For Post-transplant stage III or IV CKD patients:

  • Women pregnant or breastfeeding
  • Adults with a life expectancy of less than one year
  • A history of significant liver disease or congestive heart failure
  • Hospitalization within the last three months
  • Active infection on antibiotic therapy
  • Uncontrolled hypertension (>140/90)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy control
Healthy control that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).
Other: Flow-mediated dilation
Flow-mediated dilation used to measure vascular function. The test is minimally invasive, with only a slight discomfort due to the inflation of the arm cuff.
Other: single blood draw
single blood draw of approximately 45 mL.
Stage III or IV CKD patients
Stage III or IV CKD patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).
Other: Flow-mediated dilation
Flow-mediated dilation used to measure vascular function. The test is minimally invasive, with only a slight discomfort due to the inflation of the arm cuff.
Other: single blood draw
single blood draw of approximately 45 mL.
Post-transplant patients
Stage III or IV CKD Post-transplant patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).
Other: Flow-mediated dilation
Flow-mediated dilation used to measure vascular function. The test is minimally invasive, with only a slight discomfort due to the inflation of the arm cuff.
Other: single blood draw
single blood draw of approximately 45 mL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vascular Function
Time Frame: percent change from baseline over 2 minutes
This will be measured with flow-mediated dilation and evaluate percent change from baseline over minutes.
percent change from baseline over 2 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of Microparticle source from blood analysis
Time Frame: Single time point
A single blood draw to distinguish micro particle source characterization based upon protein, lipid and cholesterol composition.
Single time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Joshua M Thurman, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-1209
  • UL1TR001082 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Disease

Clinical Trials on Flow-mediated dilation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe