Oxidative stress is highly prevalent in patients with end-stage renal disease and is linked to excess cardiovascular risk. Identifying therapies that reduce oxidative stress has the potential to improve cardiovascular outcomes in patients undergoing maintenance dialysis.

Placebo-controlled, 3-arm, double-blind, randomized, clinical trial.

65 patients undergoing thrice-weekly maintenance hemodialysis.

Patients were randomly assigned in a 1:1:1 ratio to receive once-daily coenzyme Q₁₀ (CoQ₁₀; 600 or 1,200 mg) or matching placebo for 4 months.

The primary outcome was plasma oxidative stress, defined as plasma concentration of F₂-isoprotanes. Secondary outcomes included levels of plasma isofurans, levels of cardiac biomarkers, predialysis blood pressure, and safety/tolerability.

F₂-isoprostanes and isofurans were measured as plasma markers of oxidative stress, and N-terminal pro−brain natriuretic peptide and troponin T were measured as cardiac biomarkers at baseline and 1, 2, and 4 months.

Of 80 randomly assigned patients, 15 were excluded due to not completing at least 1 postbaseline study visit and 65 were included in the primary intention-to-treat analysis. No treatment-related major adverse events occurred. Daily treatment with 1,200 mg, but not 600 mg, of CoQ₁₀ significantly reduced plasma F₂-isoprostanes concentrations at 4 months compared to placebo (adjusted mean changes of −10.7 [95% CI, −7.1 to −14.3] pg/mL [P < 0.001] and −8.3 [95% CI, −5.5 to −11.0] pg/mL [P = 0.1], respectively). There were no significant effects of CoQ₁₀ treatment on levels of plasma isofurans, cardiac biomarkers, or predialysis blood pressures.

Study not powered to detect small treatment effects; difference in baseline characteristics among randomized groups.

In patients undergoing maintenance hemodialysis, daily supplementation with 1,200 mg of CoQ₁₀ is safe and results in a reduction in plasma concentrations of F₂-isoprostanes, a marker of oxidative stress. Future studies are needed to determine whether CoQ₁₀ supplementation improves clinical outcomes for patients undergoing maintenance hemodialysis.