Chronic Kidney Disease
Conditions
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).
Interventions
OTHERFlow-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.
OTHERsingle blood draw
single blood draw of approximately 45 mL.
Sponsors
University of Colorado, Denver
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed