Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

End-stage Renal Disease Clinical Trial

Official title:

Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237718
• Other study ID #: 050377
• Status: Completed
• Phase: Phase 2
• First received: October 10, 2005
• Last updated: January 9, 2012
• Start date: April 2006
• Est. completion date: September 2010

Study information

• Verified date: January 2012
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Fresenius Medical Care North America	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Fresenius Medical Care North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	F2-isoprostane (F2-iso)	F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.	month 6	No
Secondary	Interleukin-6 (IL-6)	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.	month 6	No