Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00308971
Status:
COMPLETED
Last Update Posted:
2009-07-09
First Post:
2006-03-28
Brief Title:
Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease TALAT
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease TALAT
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None