Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

Completed · Phase 2 · Has a placebo group

Conditions studied: End-stage Renal Disease

In brief

Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood markers which their body makes in response to increased stress and injury. An increase in these markers have been shown to be related to cardiovascular disease and death in ESRD patients. This study will examine whether antioxidant therapy (Vitamin E and alpha lipoic acid) may decrease these markers.

Key facts

Study ID

NCT00237718

Run by

Vanderbilt University

People needed

385

Starts

2006-04-01

Expected to finish

2010-09-01

Last updated by the study team

2012-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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 over study duration
• History of poor adherence to hemodialysis or medical regimen
• Prisoners, patients with significant mental illness, pregnant women, and other vulnerable populations
• Patients taking vitamin E supplements > 60 IU/day, vitamin C > 500 mg/day over the past 30 days
• Patients taking anti-inflammatory medication except aspirin < 325 mg/day over the past 30 days
• Patients using a temporary catheter for dialysis access
• More than two hospitalizations within the last 90 days or one hospitalization within the last 30 days

Where it is running

• Fresenius Medical Care North America — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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