Endothelial Microparticles: A Novel Marker of Vascular Dysfunction

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Other: Flow-mediated dilation; Other: single blood draw

Study type: Observational

Funder types: Other

Identifiers

NCT02230202

14-1209

UL1TR001082 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

90 participants in 3 patient groups

Healthy control

Description:

Healthy control that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).

Treatment:

Other: single blood draw

Other: Flow-mediated dilation

Stage III or IV CKD patients

Description:

Stage III or IV CKD patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).

Treatment:

Other: single blood draw

Other: Flow-mediated dilation

Post-transplant patients

Description:

Stage III or IV CKD Post-transplant patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).

Treatment:

Other: single blood draw

Other: Flow-mediated dilation