CoQ10 Biomarker Trial

Completed · Not applicable · Has a placebo group

Conditions studied: Oxidative Stress, Inflammation, Endothelial Dysfunction

In brief

The investigators believe that relieving the oxidative stress experienced by hemodialysis patients may help improve cardiovascular health. In this study, the investigators hypothesize that administration of coenzyme Q10, as a targeted antioxidant therapy, will ameliorate the excessive oxidative stress experienced by hemodialysis patients. This will lead to improvements in biomarkers of: * oxidative stress status * inflammatory status * endothelial dysfunction

Key facts

Study ID

NCT01408680

Run by

University of Washington

People needed

66

Starts

2011-11-01

Expected to finish

2013-12-01

Last updated by the study team

2014-12-04

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with end-stage renal disease receiving thrice weekly hemodialysis
• Age ≥ 18 or ≤ 85 years
• Life expectancy greater than one year
• Ability to understand and provide informed consent for participation in the study

You may not qualify if…

• History of poor adherence to hemodialysis or medical regimen
• Prisoners, patients with significant mental illness, and other vulnerable populations
• AIDS (HIV seropositivity is not an exclusion criteria)
• Active malignancy excluding basal cell carcinoma of the skin
• Gastrointestinal dysfunction requiring parenteral nutrition
• History of functional kidney transplant < 6 months prior to study entry
• Anticipated live donor kidney transplant
• Patients taking vitamin E supplements > 60 IU/day, vitamin C > 150 mg/day or other antioxidant or nutritional supplements
• Incident hemodialysis patients (defined as within 90 days of dialysis initiation)
• Patients hospitalized for more than 5 days within the past 30 days.
• Patients being dialyzed with a tunneled catheter as a temporary vascular access
• Patients with a history of a major atherosclerotic event (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery, and stroke) within six months
• Pregnancy

Where it is running

• Northwest Kidney Centers — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.