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Status:

COMPLETED

Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)

Lead Sponsor:

Vanderbilt University

Conditions:

Chronic Kidney Disease

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in both the chronic kidney disease (CKD; pre-dialysis) and end stage renal disease (ESRD; on hemodialysis) popul...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Patients with Stage III-IV chronic kidney disease measured by MDRD formula.
  • age \> 18 or \< 75 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 hepatitis C or B
  • Active gout
  • Other active inflammatory diseases.
  • Active malignancy excluding basal or squamous cell carcinoma of the skin.
  • Gastrointestinal dysfunction requiring parental nutrition.
  • History of functional kidney transplant \< 6 months prior to study entry.
  • Anticipated live donor kidney transplant over study duration.
  • Prisoners, patients will significant mental illness, pregnant women, and other vulnerable populations.
  • Patients taking Vitamin E supplements \> 60 IU/day, vitamin C\> 500mg/day over the past 30days.
  • Patients taking anti-inflammatory medication except aspirin \< 325mg/day over the past 30 days.
  • Patient taking any prednisone therapy.
  • More than two hospitalizations within the last 90 days or one hospitalization within the last 30 days.
  • On experimental drug protocols.
  • Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin.
  • Hypersensitivity to vitamin E or alpha lipoic acid.
  • Pregnant women

Exclusion

    Key Trial Info

    Start Date :

    March 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2007

    Estimated Enrollment :

    62 Patients enrolled

    Trial Details

    Trial ID

    NCT00308971

    Start Date

    March 1 2006

    End Date

    July 1 2007

    Last Update

    July 9 2009

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    Maine Medical Center

    Portland, Maine, United States, 04102

    2

    Vanderbilt University Medical Center

    Nashville, Tennessee, United States, 37232