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Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

This study has been completed.
Sponsor:
Collaborator:
Fresenius Medical Care North America
Information provided by (Responsible Party):
Alp Ikizler, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00237718
First received: October 10, 2005
Last updated: January 9, 2012
Last verified: January 2012
  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 2

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
Official Title: Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • F2-isoprostane (F2-iso) [ Time Frame: month 6 ] [ Designated as safety issue: No ]
    F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.


Secondary Outcome Measures:
  • Interleukin-6 (IL-6) [ Time Frame: month 6 ] [ Designated as safety issue: No ]
    IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.


Enrollment: 385
Study Start Date: April 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ALA and Vitamin E
600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of alpha, gamma, beta and delta (mixed) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
Drug: Alpha, gamma, beta, and delta (mixed) tocopherols
approximately 666 IU daily (1 pill) for 6 months
Other Name: Vitamin E
Drug: Alpha lipoic acid
600 mg daily (2 pills 300 mg each) for 6 months
Placebo Comparator: Placebo
placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Tennessee
Fresenius Medical Care North America
Nashville, Tennessee, United States, 37215
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

No publications provided

Responsible Party: Alp Ikizler, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00237718     History of Changes
Other Study ID Numbers: 050377
Study First Received: October 10, 2005
Results First Received: September 1, 2011
Last Updated: January 9, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Alpha-Tocopherol
Antioxidants
Thioctic Acid
Tocopherols
Tocotrienols
Vitamin E
Vitamins
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex

ClinicalTrials.gov processed this record on November 27, 2014