Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00237718
• Date of registration: 10/10/2005
• Primary sponsor: Vanderbilt University
• Public title: Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
• Scientific title: Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
• Date of first enrolment: April 2006
• Target sample size: 385
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00237718
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jonathan Himmelfarb, MD
• Affiliation: Maine Medical Center

• Name: Alp Ikizler, MD
• Affiliation: Vanderbilt University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients with end-stage renal disease receiving thrice weekly hemodialysis

2. Age > 18 years

3. Life expectancy greater than one year

4. Ability to understand and provide informed consent for participation in the study

Exclusion Criteria:

1. AIDS (HIV seropositivity is not an exclusion criteria)

2. Active malignancy excluding basal cell carcinoma of the skin

3. Gastrointestinal dysfunction requiring parenteral nutrition

4. History of functional kidney transplant < 6 months prior to study entry

5. Anticipated live donor kidney transplant over study duration

6. History of poor adherence to hemodialysis or medical regimen

7. Prisoners, patients with significant mental illness, pregnant women, and other
vulnerable populations

8. Patients taking vitamin E supplements > 60 IU/day, vitamin C > 500 mg/day over the
past 30 days

9. Patients taking anti-inflammatory medication except aspirin < 325 mg/day over the
past 30 days

10. Patients using a temporary catheter for dialysis access

11. More than two hospitalizations within the last 90 days or one hospitalization within
the last 30 days



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

End-stage Renal Disease

Intervention(s)

Drug: Alpha lipoic acid

Drug: Alpha, gamma, beta, and delta (mixed) tocopherols

Drug: Placebo

Primary Outcome(s)

F2-isoprostane (F2-iso) [Time Frame: month 6]

Secondary Outcome(s)

Interleukin-6 (IL-6) [Time Frame: month 6]

Secondary ID(s)

050377

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fresenius Medical Care North America