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	Phase II

Further study details as provided by Vanderbilt University:

Primary Outcomes: The primary outcome will be a significant change in biomarkers of acute phase inflammation.
Secondary Outcomes: The secondary outcome will be a significant change in biomarkers of oxidative stress status including measures of amino acid, protein, and lipid oxidation.
Expected Total Enrollment:  300

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 proatherosclerotic 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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Patients with end-stage renal disease receiving thrice weekly hemodialysis
2. Age > 18 or < 75 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00237718

Karen Majchrzak, MS      615-343-8296    karen.majchrzak@vanderbilt.edu

Tennessee
      Renal Care Group, Nashville,  Tennessee,  37215,  United States

Study chairs or principal investigators

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

Study ID Numbers:  050377
Last Updated:  December 8, 2005
Record first received:  October 10, 2005
ClinicalTrials.gov Identifier:  NCT00237718
Health Authority: USA:Vanderbilt University Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10