Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
MitoQ
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Endothelium, vascular, MitoQ, Mitochondria, Oxidative Stress, Chronic Renal Insufficiency, Cardiovascular Disease
Eligibility Criteria
Inclusion Criteria:
- Stage 3 - 5 Chronic Kidney Disease
Exclusion Criteria:
- History of cardiovascular disease;
- Current pregnancy;
- Uncontrolled hypertension;
- Uncontrolled hyperlipidemia;
- Current hormone replacement therapy;
- Current use of tobacco products;
- Elevated liver enzymes;
- Current autoimmune disease;
- Daily use of of antioxidants >300mg
Sites / Locations
- Department of Kinesiology and Applied Physiology, University of DelawareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MitoQ
Placebo
Arm Description
4 week 20mg oral daily dose of MitoQ
4 week 20mg oral daily placebo
Outcomes
Primary Outcome Measures
Microvascular Function, assessed by laser Doppler flowmetry coupled with microdialysis
Nitric oxide mediated cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with microdialysis
Secondary Outcome Measures
Conduit artery endothelial dependent dilation, assessed by duplex ultrasound
Brachial artery flow mediated dilation assessed by duplex ultrasound
Mitochondria derived superoxide, assessed by electron paramagnetic resonance spectroscopy
Plasma mitochondria superoxide assessed by electron paramagnetic resonance spectroscopy
Full Information
NCT ID
NCT02364648
First Posted
February 10, 2015
Last Updated
April 24, 2019
Sponsor
University of Delaware
1. Study Identification
Unique Protocol Identification Number
NCT02364648
Brief Title
Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease
Official Title
Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to examine the effect of mitochondria derived oxidative stress on vascular function in patients with moderate to severe Chronic Kidney Disease.
Detailed Description
Chronic Kidney Disease (CKD) patients are at increased risk of cardiovascular disease. Endothelial dysfunction, characterized by a reduced bioavailability in nitric oxide, is an independent predictor of cardiovascular disease in CKD. Increased oxidative stress is a potential cause of endothelial dysfunction in this patient cohort. This study investigates the role that mitochondrial derived oxidative stress plays in CKD related vascular dysfunction. In a controlled, double blinded trial, Stage 3-5 CKD patients will be randomly assigned to receive a 4 week daily dose of a mitochondria targeted antioxidant (MitoQ) or a placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Endothelium, vascular, MitoQ, Mitochondria, Oxidative Stress, Chronic Renal Insufficiency, Cardiovascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MitoQ
Arm Type
Experimental
Arm Description
4 week 20mg oral daily dose of MitoQ
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
4 week 20mg oral daily placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
MitoQ
Intervention Description
Mitochondria targeted antioxidant
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Microvascular Function, assessed by laser Doppler flowmetry coupled with microdialysis
Description
Nitric oxide mediated cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with microdialysis
Time Frame
Change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Conduit artery endothelial dependent dilation, assessed by duplex ultrasound
Description
Brachial artery flow mediated dilation assessed by duplex ultrasound
Time Frame
Change from baseline at 4 weeks
Title
Mitochondria derived superoxide, assessed by electron paramagnetic resonance spectroscopy
Description
Plasma mitochondria superoxide assessed by electron paramagnetic resonance spectroscopy
Time Frame
Change from baseline at 4 weeks
Other Pre-specified Outcome Measures:
Title
Endothelial cell NADPH oxidase expression
Description
NADPH oxidase expression in human endothelial cll expression
Time Frame
Change from baseline at 4 weeks
Title
Arterial Stiffness, assessed by central blood pressure, augmentation index and carotid artery to femoral artery pulse wave velocity
Description
Central blood pressure, augmentation index and carotid artery to femoral artery pulse wave velocity
Time Frame
Change from baseline at 4 weeks
Title
Ambulatory Blood Pressure
Description
2h hour continuous ambulatory blood pressure monitoring
Time Frame
Change from baseline at 4 weeks
Title
Habitual Physical Activity, assessed by accelerometry
Description
Daily habitual physical activity assessed by accelerometry
Time Frame
Change from baseline at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage 3 - 5 Chronic Kidney Disease
Exclusion Criteria:
History of cardiovascular disease;
Current pregnancy;
Uncontrolled hypertension;
Uncontrolled hyperlipidemia;
Current hormone replacement therapy;
Current use of tobacco products;
Elevated liver enzymes;
Current autoimmune disease;
Daily use of of antioxidants >300mg
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle L Kirkman, PhD
Phone
302 831 4659
Email
dkirkman@udel.edu
First Name & Middle Initial & Last Name or Official Title & Degree
David G Edwards, PhD
Email
dge@udel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle L Kirkman, PhD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David G Edwards, PhD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Kinesiology and Applied Physiology, University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Edwards, PhD
Email
dge@udel.edu
First Name & Middle Initial & Last Name & Degree
Danielle Kirkman, PhD
Email
dkirkman@udel.edu
First Name & Middle Initial & Last Name & Degree
Danielle Kirkman, PhD
First Name & Middle Initial & Last Name & Degree
David Edwards, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease
We'll reach out to this number within 24 hrs