Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
February 18, 2015
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedApril 25, 2019
April 1, 2019
2.2 years
February 10, 2015
April 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Change from baseline at 4 weeks
Secondary Outcomes (2)
Conduit artery endothelial dependent dilation, assessed by duplex ultrasound
Change from baseline at 4 weeks
Mitochondria derived superoxide, assessed by electron paramagnetic resonance spectroscopy
Change from baseline at 4 weeks
Other Outcomes (4)
Endothelial cell NADPH oxidase expression
Change from baseline at 4 weeks
Arterial Stiffness, assessed by central blood pressure, augmentation index and carotid artery to femoral artery pulse wave velocity
Change from baseline at 4 weeks
Ambulatory Blood Pressure
Change from baseline at 4 weeks
- +1 more other outcomes
Study Arms (2)
MitoQ
EXPERIMENTAL4 week 20mg oral daily dose of MitoQ
Placebo
PLACEBO COMPARATOR4 week 20mg oral daily placebo
Interventions
Eligibility Criteria
You may qualify if:
- Stage 3 - 5 Chronic Kidney Disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Kinesiology and Applied Physiology, University of Delaware
Newark, Delaware, 19713, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle L Kirkman, PhD
University of Delaware
- PRINCIPAL INVESTIGATOR
David G Edwards, PhD
University of Delaware
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 10, 2015
First Posted
February 18, 2015
Study Start
July 1, 2017
Primary Completion
August 30, 2019
Study Completion
September 30, 2019
Last Updated
April 25, 2019
Record last verified: 2019-04