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Completed

NCT Number: NCT02230202

Endothelial Microparticles: A Novel Marker of Vascular Dysfunction

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus; CTRC, Aurora, Colorado, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Flow-mediated dilation

Other

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.

single blood draw

Other

single blood draw of approximately 45 mL.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 3, 2014
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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