Chronic Kidney Disease Clinical Trial
Official title:
Endothelial Microparticles: A Novel Marker of Vascular Dysfunction
Verified date | February 2018 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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) |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
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 |
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