Endothelial Microparticles: A Novel Marker of Vascular Dysfunction

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Other: Flow-mediated dilation; Other: single blood draw

• Registration Number: NCT02230202
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

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 Timeline

• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-08-29
• Study Start: 2014-09
• Study First Posted: 2014-09-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy control	single blood draw	Healthy control that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).
Stage III or IV CKD patients	single blood draw	Stage III or IV CKD patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).
Healthy control	Flow-mediated dilation	Healthy control that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).
Post-transplant patients	single blood draw	Stage III or IV CKD Post-transplant patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).
Stage III or IV CKD patients	Flow-mediated dilation	Stage III or IV CKD patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).
Post-transplant patients	Flow-mediated dilation	Stage III or IV CKD Post-transplant patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).

Primary Outcome Measures

Name	Time	Method
Change in Vascular Function	percent change from baseline over 2 minutes	This will be measured with flow-mediated dilation and evaluate percent change from baseline over minutes.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

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

University of Colorado School of Medicine; 🇺🇸 Aurora, Colorado, United States