Chronic Kidney DiseasePhase 4NCT02364648
Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease
A Phase 4 study testing MitoQ in people with Chronic Kidney Disease, run by University of Delaware at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- MitoQ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 30 Sep 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 3 - 5 Chronic Kidney Disease
Who cannot join
- History of cardiovascular disease;
- Current pregnancy;
- Uncontrolled hypertension;
- Uncontrolled hyperlipidemia;
- Current hormone replacement therapy;
- Current use of tobacco products;
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- Elevated liver enzymes;
- Current autoimmune disease;
- Daily use of of antioxidants >300mg
Trial locations and contacts
1 site in 1 country.
David G Edwards, PhD contact
United States1 site, 1 recruiting
- Recruiting
Department of Kinesiology and Applied Physiology, University of Delaware
Newark, Delaware, 19713
David Edwards, PhD, dge@udel.edu
Danielle Kirkman, PhD, dkirkman@udel.edu
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- MitoQ, Placebo
- Keywords
- Endothelium, vascular, MitoQ, Mitochondria, Oxidative Stress, Chronic Renal Insufficiency, Cardiovascular Disease
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoQDietary supplement
Mitochondria targeted antioxidant
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MitoQ | Experimental | 4 week 20mg oral daily dose of MitoQ Receives: Dietary Supplement: MitoQ |
| Placebo | Placebo comparator | 4 week 20mg oral daily placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline at 4 weeks
Secondary outcomes (2)
Conduit artery endothelial dependent dilation, assessed by duplex ultrasound
Brachial artery flow mediated dilation assessed by duplex ultrasound
Measured: Change from baseline at 4 weeks
Mitochondria derived superoxide, assessed by electron paramagnetic resonance spectroscopy
Plasma mitochondria superoxide assessed by electron paramagnetic resonance spectroscopy
Measured: Change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study start1 Jul 2017
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Edwards, University of Delaware
- Investigators
- Danielle L Kirkman, PhD, Principal investigator, University of DelawareDavid G Edwards, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364648
- Sponsor's protocol ID
- 680076-2
- Status last verified
- Apr 2019
- First submitted
- 10 Feb 2015
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02364648
- Acronym / sponsor ID
- 680076-2
- Conditions
- Chronic Kidney Disease
- Keywords
- Endothelium, vascular, MitoQ, Mitochondria, Oxidative Stress, Chronic Renal Insufficiency, Cardiovascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 18 Feb 2015 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MitoQ | Experimental | Dietary Supplement: MitoQ4 week 20mg oral daily dose of MitoQ |
| Placebo | Placebo comparator | Dietary Supplement: Placebo4 week 20mg oral daily placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stage 3 - 5 Chronic Kidney Disease
Key exclusion criteria (9 listed)
- History of cardiovascular disease;
- Current pregnancy;
- Uncontrolled hypertension;
- Uncontrolled hyperlipidemia;
- Current hormone replacement therapy;
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 |
|---|---|---|
| MitoQMitochondria targeted antioxidant | Dietary supplement | MitoQ |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Microvascular Function, assessed by laser Doppler flowmetry coupled with microdialysis
Time frame: Change from baseline at 4 weeks
Nitric oxide mediated cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with microdialysis
2 secondary outcomes
Conduit artery endothelial dependent dilation, assessed by duplex ultrasound
Time frame: Change from baseline at 4 weeks
Mitochondria derived superoxide, assessed by electron paramagnetic resonance spectroscopy
Time frame: Change from baseline at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
David G Edwards, PhD contact
Danielle L Kirkman, PhD principal investigator
University of Delaware
David G Edwards, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MitoQ in people with Chronic Kidney Disease, run by University of Delaware at 1 site 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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danielle L Kirkman, PhD (302 831 4659, dkirkman@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular Function, assessed by laser Doppler flowmetry coupled with microdialysis (time frame: Change from baseline at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.