drugset / Trial / NCT00308971

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

NCT00308971

Phase 2 Completed 62 enrolled Vanderbilt University
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2006-03
Primary completion
2007-07
Completion
2007-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alpha, gamma, beta, and delta (mixed) tocopherols Unknown 666 iu
Comparator alpha-lipoic acid Small molecule 600 mg