Status:
COMPLETED
Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Fresenius Medical Care North America
Conditions:
End-stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in the hemodialysis population, and several lines of evidence point to their contribution in atherosclerosis dev...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT00237718
Start Date
April 1 2006
End Date
September 1 2010
Last Update
January 11 2012
Active Locations (1)
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1
Fresenius Medical Care North America
Nashville, Tennessee, United States, 37215