Chronic Kidney DiseaseNCT02230202
Endothelial Microparticles: A Novel Marker of Vascular Dysfunction
An observational study of Chronic Kidney Disease, run by University of Colorado, Denver at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Flow-mediated dilation and single blood draw
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Mar 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 90 volunteers from the Anschutz Medical Campus
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Anschutz Medical Campus; CTRC
Aurora, Colorado, 80045
University of Colorado School of Medicine
Aurora, Colorado, 80045
About this study
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.
Read the 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).
- Conditions
- Chronic Kidney Disease
- Being tested
- Flow-mediated dilation, single blood draw
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow-mediated dilationOther
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 drawOther
single blood draw of approximately 45 mL.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | Healthy control that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD). Receives: Other: Flow-mediated dilation; Other: single blood draw | |
| Stage III or IV CKD patients | Stage III or IV CKD patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD). Receives: Other: Flow-mediated dilation; Other: single blood draw | |
| Post-transplant patients | Stage III or IV CKD Post-transplant patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD). Receives: Other: Flow-mediated dilation; Other: single blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vascular Function
This will be measured with flow-mediated dilation and evaluate percent change from baseline over minutes.
Measured: percent change from baseline over 2 minutes
Secondary outcomes (1)
Characterization of Microparticle source from blood analysis
A single blood draw to distinguish micro particle source characterization based upon protein, lipid and cholesterol composition.
Measured: Single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua M Thurman, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230202
- Sponsor's protocol ID
- 14-1209
- Other IDs
- UL1TR001082
- Status last verified
- Feb 2018
- First submitted
- 25 Aug 2014
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30006493
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Microparticles: A Novel Marker of Vascular Dysfunction
- ClinicalTrials.gov ID
- NCT02230202
- Acronym / sponsor ID
- 14-1209
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control | – | Other: Flow-mediated dilation, Other: single blood drawHealthy control that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD). |
| Stage III or IV CKD patients | – | Other: Flow-mediated dilation, Other: single blood drawStage III or IV CKD patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD). |
| Post-transplant patients | – | Other: Flow-mediated dilation, Other: single blood drawStage III or IV CKD Post-transplant patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 90 volunteers from the Anschutz Medical Campus
Key inclusion criteria (11 listed)
- BMI less than 40 kg/m^2
- Able to give informed consent
- 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
Key exclusion criteria (17 listed)
- -Women pregnant or breastfeeding
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow-mediated dilationFlow-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. | Other | Healthy control, Post-transplant patients, Stage III or IV CKD patients |
| single blood drawsingle blood draw of approximately 45 mL. | Other | Healthy control, Post-transplant patients, Stage III or IV CKD patients |
Primary outcome
Change in Vascular Function
Time frame: percent change from baseline over 2 minutes
This will be measured with flow-mediated dilation and evaluate percent change from baseline over minutes.
1 secondary outcome
Characterization of Microparticle source from blood analysis
Time frame: Single time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Derived from this study: PubMed 30006493Jalal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua M Thurman, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vascular Function (time frame: percent change from baseline over 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02230202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.