Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

NCT ID: NCT00237718

Last Updated: 2012-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 385 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2010-09-30

Brief 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.

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.

Conditions

End-stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

approximately 666 IU daily (1 pill) for 6 months

Alpha lipoic acid

Intervention Type: DRUG

600 mg daily (2 pills 300 mg each) for 6 months

Placebo

placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months

Placebo

Intervention Type: DRUG

placebo for alpha lipoic acid; 2 pills daily for 6 months

Interventions

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

approximately 666 IU daily (1 pill) for 6 months

Intervention Type: DRUG

Alpha lipoic acid

600 mg daily (2 pills 300 mg each) for 6 months

Intervention Type: DRUG

Placebo

placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months

Intervention Type: DRUG

Placebo

placebo for alpha lipoic acid; 2 pills daily for 6 months

Intervention Type: DRUG

Other Intervention Names

Vitamin E

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Medical Care North America

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Alp Ikizler

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Himmelfarb, MD

Role: PRINCIPAL_INVESTIGATOR

MaineHealth

Alp Ikizler, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Fresenius Medical Care North America

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

050377

Identifier Type: -

Identifier Source: org_study_id