Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02364648
• Other study ID #: 680076-2
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: April 2019
• Source: University of Delaware
• Contact: Danielle L Kirkman, PhD
• Phone: 302 831 4659
• Email: dkirkman[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• MitoQ
Mitochondria targeted antioxidant
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Department of Kinesiology and Applied Physiology, University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Endothelial cell NADPH oxidase expression	NADPH oxidase expression in human endothelial cll expression	Change from baseline at 4 weeks
Other	Arterial Stiffness, assessed by central blood pressure, augmentation index and carotid artery to femoral artery pulse wave velocity	Central blood pressure, augmentation index and carotid artery to femoral artery pulse wave velocity	Change from baseline at 4 weeks
Other	Ambulatory Blood Pressure	2h hour continuous ambulatory blood pressure monitoring	Change from baseline at 4 weeks
Other	Habitual Physical Activity, assessed by accelerometry	Daily habitual physical activity assessed by accelerometry	Change from baseline at 4 weeks
Primary	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	Conduit artery endothelial dependent dilation, assessed by duplex ultrasound	Brachial artery flow mediated dilation assessed by duplex ultrasound	Change from baseline at 4 weeks
Secondary	Mitochondria derived superoxide, assessed by electron paramagnetic resonance spectroscopy	Plasma mitochondria superoxide assessed by electron paramagnetic resonance spectroscopy	Change from baseline at 4 weeks