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Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients

2014-07-24 14:25:37 | BioPortfolio

Summary

Etanercept is a novel anti-inflammatory agent currently used in patients with rheumatoid arthritis. We are examining whether etanercept is effective in improving the nutritional status of hemodialysis patients as a consequence of its ability to decrease inflammation. Hemodialysis patients with end stage renal disease have a high mortality rate. In individual patients, mortality is associated with a low serum albumin concentration, a marker of poor nutritional status, and with elevated C-reactive protein, a marker of inflammation. Since efforts to improve nutrition through dietary intake have not been successful, inflammation is thought to play a key role in determining nutritional status. Recently, it has been shown that malnutrition, inflammation, and atherosclerosis are closely related in patients with chronic renal failure. It is our hypothesis that suppression of the cycle of inflammation, malnutrition, and vascular injury caused by atherosclerosis will improve survival in dialysis patients. This study is designed to examine whether suppression of the inflammatory response can be accomplished safely with etanercept and to determine if this suppression will improve nutritional status and clinical outcome in hemodialysis patients with poor nutritional status and evidence of inflammation.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

End Stage Renal Disease

Intervention

Etanercept, Saline

Location

University of California, Davis, Medical Center
Sacramento
California
United States
95817

Status

Active, not recruiting

Source

Kaysen, George A., M.D., Ph.D.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:25:37-0400

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