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NCT00308971 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Chronic Kidney Disease, sponsored by Vanderbilt University.

Completed
Registry status
Phase 2
Development phase
62
Enrollment target
2
Study locations

NCT00308971 is a Phase 2 study of Chronic Kidney Disease that has completed, run by Vanderbilt University. The registered enrollment target is 62 participants, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00308971, a Phase 2 study of Chronic Kidney Disease, has completed, sponsored by Vanderbilt University.

COMPLETED
Registry status
Phase 2
Development phase
62 participants
Enrollment target
2
Study locations

Study 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) populations, and several lines of evidence point to their contribution in the development of atherosclerosis. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and death in these two populations. 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 in patients with Stage III and IV CKD.

Conditions Studied

Chronic Kidney Disease

Interventions

  • DRUG placebo
  • DRUG Alpha, gamma, beta, and delta (mixed) tocopherols
  • DRUG alpha lipoic acid

Study Locations (2)

Maine

  • Maine Medical Center - Portland

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2006-03
Est. Completion 2007-07
Phase Phase 2

Sponsor

Vanderbilt University

430 total trials

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What the Registry Record Tells You About NCT00308971

The ClinicalTrials.gov registry entry for NCT00308971 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (98% lower). The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Kidney Disease appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.

NCT00308971 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maine, Tennessee.

Frequently Asked Questions

What is clinical trial NCT00308971 about?

NCT00308971 is a clinical study titled "Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)". 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) populations, and several lines of evidence point to their contribution in the development of atherosclero...

What is the current status of trial NCT00308971?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2006-03. Estimated completion is 2007-07.

What conditions does trial NCT00308971 study?

This clinical trial studies the following conditions: Chronic Kidney Disease.

What interventions are being tested in trial NCT00308971?

The interventions under investigation include: placebo (DRUG), Alpha, gamma, beta, and delta (mixed) tocopherols (DRUG), alpha lipoic acid (DRUG).

Who is sponsoring clinical trial NCT00308971?

This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00308971 being conducted?

This trial has 2 study locations across Maine, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.