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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
Health authority
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)

Study Design


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
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