Endothelial Microparticles: A Novel Marker of Vascular Dysfunction

Chronic Kidney Disease Clinical Trial

Official title:

Endothelial Microparticles: A Novel Marker of Vascular Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230202
• Other study ID #: 14-1209
• Secondary ID: UL1TR001082
• Status: Completed
• Phase: N/A
• First received: August 25, 2014
• Last updated: February 26, 2018
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: February 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• single blood draw
single blood draw of approximately 45 mL.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus; CTRC	Aurora	Colorado
United States	University of Colorado School of Medicine	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Vascular Function	This will be measured with flow-mediated dilation and evaluate percent change from baseline over minutes.	percent change from baseline over 2 minutes
Secondary	Characterization of Microparticle source from blood analysis	A single blood draw to distinguish micro particle source characterization based upon protein, lipid and cholesterol composition.	Single time point