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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: Completed Phase 2 study of Chronic Kidney Disease, sponsored by Vanderbilt University.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2006-03 |
| Est. Completion | 2007-07 |
| Phase | Phase 2 |
What the finished NCT00308971 record still lists
NCT00308971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Chronic Kidney Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00308971's enrollment target sits among peer trials
62 67th of 101 higher than 35 of 101 other Chronic Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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