Clinical trial NCT02230202: Endothelial Microparticles: A Novel Marker of Vascular Dysfunction
Official title: Endothelial Microparticles: A Novel Marker of Vascular Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 90 volunteers from the Anschutz Medical Campus

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Vascular Function
timeFrame: percent change from baseline over 2 minutes
Secondary outcomes:
measure: Characterization of Microparticle source from blood analysis
timeFrame: Single time point
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus; CTRC
state: Colorado
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Joshua M Thurman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jalal D, Renner B, Laskowski J, Stites E, Cooper J, Valente K, You Z, Perrenoud L, Le Quintrec M, Muhamed I, Christians U, Klawitter J, Lindorfer MA, Taylor RP, Holers VM, Thurman JM. Endothelial Microparticles and Systemic Complement Activation in Patients With Chronic Kidney Disease. J Am Heart Assoc. 2018 Jul 13;7(14):e007818. doi: 10.1161/JAHA.117.007818.