Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

NCT00237718 | Completed Phase 2 Results DMC

• 1 other identifier: 050377
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Interleukin-6 (IL-6)

  month 6

Study Arms (2)

ALA and Vitamin E

ACTIVE COMPARATOR

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; Drug: Alpha lipoic acid

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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

approximately 666 IU daily (1 pill) for 6 months

Also known as: Vitamin E

ALA and Vitamin E

Alpha lipoic acid DRUG

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

ALA and Vitamin E

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• Fresenius Medical Care North America: collaborator

Study Sites (1)

Fresenius Medical Care North America

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Gamma Rays; YY1 Transcription Factor; Tocopherols; Vitamin E; Thioctic Acid

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Erythroid-Specific DNA-Binding Factors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Transcription Factors; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Results Point of Contact

• Title: T. Alp Ikizler, MD
• Organization: Vanderbilt University

alp.ikizler@vanderbilt.edu

Study Officials

• Jonathan Himmelfarb, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

• Alp Ikizler, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2005
• First Posted: October 12, 2005
• Study Start: April 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 11, 2012
• Results First Posted: October 5, 2011

Record last verified: 2012-01

Locations

US (1)