Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

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

Alpha lipoic acid

Placebo

About this trial

This is an interventional treatment trial for End-stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fresenius Medical Care North America

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ALA and Vitamin E

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

F2-isoprostane (F2-iso)

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)

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.

Full Information

NCT ID

NCT00237718

First Posted

October 10, 2005

Last Updated

January 9, 2012

Sponsor

Vanderbilt University

Collaborators

Fresenius Medical Care North America

1. Study Identification

Unique Protocol Identification Number

NCT00237718

Brief Title

Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

Official Title

Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

Collaborators

Fresenius Medical Care North America

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End-stage Renal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

385 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALA and Vitamin E

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Vitamin E

Intervention Description

approximately 666 IU daily (1 pill) for 6 months

Intervention Type

Drug

Intervention Name(s)

Alpha lipoic acid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

F2-isoprostane (F2-iso)

Description

F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.

Time Frame

month 6

Secondary Outcome Measure Information:

Title

Interleukin-6 (IL-6)

Description

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.

Time Frame

month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Himmelfarb, MD

Organizational Affiliation

MaineHealth

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alp Ikizler, MD

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fresenius Medical Care North America

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

End-stage Renal Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial