Provision of Antioxidant Therapy in Hemodialysis (PATH) Study - Full Text View

Sponsors and Collaborators:	Vanderbilt University Fresenius Medical Care North America
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00237718

Purpose

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.

Condition	Intervention	Phase
End-Stage Renal Disease	Drug: Alpha, gamma, beta, and delta (mixed) tocopherols Drug: Alpha lipoic acid Drug: Placebo	Phase II

MedlinePlus related topics: Antioxidants Dialysis Kidney Failure

Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Thioctic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

A significant change in biomarkers of acute phase inflammation, including EPO index [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A significant change in biomarkers of oxidative stress status including measures of amino acid, protein, and lipid oxidation [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	November 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Alpha, gamma, beta, and delta (mixed) tocopherols approximately 666 IU daily (1 pill) for 6 months Drug: Alpha lipoic acid 600 mg daily (2 pills 300 mg each) for 6 months
2: Placebo Comparator	Drug: Placebo placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months Drug: Placebo placebo for alpha lipoic acid; 2 pills daily for 6 months

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 development. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and mortality in the dialysis population. The uremic state is characterized by retention of oxidized solutes including reactive aldehyde groups and oxidized thiol groups. It has recently been demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the atherosclerotic uremic metabolic state. In this study we hypothesize that administration of antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress while improving the erythropoietic response in hemodialysis patients.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237718

Contacts

Contact: Charles D Ellis, PhD

615-343-8296

chuck.ellis@vanderbilt.edu

Locations

United States, Tennessee
Fresenius Medical Care North America	Recruiting
Nashville, Tennessee, United States, 37215
Contact: Veronica Legg 360-607-6892 veronica.legg@fmc-na.com
Sub-Investigator: Mark Kaplan, MD

Sponsors and Collaborators

Vanderbilt University

Fresenius Medical Care North America

Investigators

Principal Investigator:	Jonathan Himmelfarb, MD	Maine Medical Center
Principal Investigator:	Alp Ikizler, MD	Vanderbilt University

More Information

Responsible Party:	Vanderbilt University Medical Center ( Alp Ikizler, MD )
Study ID Numbers:	050377
Study First Received:	October 10, 2005
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00237718
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

Tocopherols
Tocopherol acetate
Vitamin E
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Thioctic Acid
Alpha-Tocopherol
Kidney Failure

Additional relevant MeSH terms:

Antioxidants
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins

Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009