Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis

End Stage Renal Failure on Dialysis Clinical Trial

Official title: Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 2

Status Completed

Clinical Trial Summary

Little is known about how some drugs affect inflammation or clotting factors in people receiving hemodialysis. It is not yet known if these drugs help prevent heart damage as they do in people not undergoing hemodialysis or whether they could increase the risk of heart problems. The purpose of the study is to measure certain chemicals in the blood and see how those chemicals may change during hemodialysis when certain drugs are given.

Clinical Trial Description

• Cardiovascular disease in the leading cause of death in patients with chronic kidney disease undergoing hemodialysis.

• Traditional risk factors do not adequately predict cardiovascular morbidity and mortality in patients with chronic kidney disease.

• Increased oxidative stress, inflammation and impaired fibrinolysis contribute to cardiovascular risk in chronic kidney disease patients undergoing hemodialysis.

• Activation of the renin-angiotensin-aldosterone system(RAAS) may contribute to oxidative stress and inflammation in individuals with chronic kidney disease

• Activation of the kallikrein-kinin system during hemodialysis may increase fibrinolysis but may also contribute to inflammation in chronic kidney disease

• Despite data from clinical trials demonstrating that ARBs and ACE inhibitors decrease cardiovascular mortality, delay progression to cardiovascular disease and decrease the incidence of diabetes in the general population little is known about the impact of these agents on cardiovascular morbidity and mortality in patients with end- stage renal disease (ESRD) undergoing hemodialysis

• Angiotensin-converting enzyme(ACE) inhibitors and angiotensin receptor blockers (ARB)S differ in their mechanisms of action and their effects on inflammatory biomarkers ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complication of Hemodialysis
• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic

• NCT number: NCT00732069
• Study type: Interventional
• Source: Vanderbilt University
• Status: Completed
• Phase: Phase 2
• Start date: August 2008
• Completion date: December 2011