CoQ10 Biomarker Trial

There are more than 400,000 patients receiving dialysis in the United States, and the
investigators expect that this number will go up. For those on hemodialysis, cardiovascular
disease (CVD) accounts for a large part of the health problems that these patients have.
Cardiovascular problems come from damage to the heart or blood vessels.

At present, the investigators have no treatments proven to help prevent CVD in those on
dialysis. For the general population, the investigators know about many factors that
increase the risk of CVD, such as having a high level of "bad" cholesterol. But for people
on dialysis, the investigators believe that there are other risk factors that are just as
important in the development of CVD.

People on dialysis often have high blood levels of waste products. This is called "uremia".
The investigators believe that uremia can set up chemical reactions in the blood which can
lead to hardening of the arteries (atherosclerosis), an important part of CVD. Compounds
called antioxidants, which stop the chemical reactions, may help prevent CVD.

Coenzyme Q10 is a naturally occurring compound in blood and tissues. It is also a readily
available dietary supplement often used as an alternative to other medicines. It is a
strong antioxidant. The investigators already know that blood levels of coenzyme Q10 are
lower in hemodialysis patients. Because of this, it is important for us to find out if
giving coenzyme Q10 to hemodialysis patients can help prevent CVD.

In addition, many people take medications called "statins" to help reduce risk for
cardiovascular disease. The investigators know that statins can lower coenzyme Q10. It is
important for us to know if hemodialysis patients taking statins have lower levels of
coenzyme Q10. It may be that taking coenzyme Q10 could increase the good effects of statin
medication in hemodialysis patients.

This study will not last long enough for us to look at the development of CVD in subjects.
But the investigators will be able to look at biomarkers of oxidative stress, systemic
inflammation, and endothelial function. The investigators know that these biomarkers tell
us about uremia and other harmful chemical reactions in the blood. If coenzyme Q10 improves
the biomarkers, then the investigators believe that it will also help prevent CVD in
hemodialysis patients. Our goal is for improvements in cardiovascular risk for those on
hemodialysis.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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