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

Condition(s) targeted: End Stage Renal Disease

Intervention: Etanercept (Drug); Saline (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Kaysen, George A., M.D., Ph.D.

Official(s) and/or principal investigator(s):
George Kaysen, MD, PhD, Principal Investigator, Affiliation: University of California, Davis

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.

Official title: The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

increased serum albumin concentration

reduced C-reactive protein concentration

Secondary outcome: effect of treatment on prealbumin concentration

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Presence of end stage renal disease

Exclusion Criteria:

- History of Tuberculosis History of Recurrent Infection Recent AMI, Cancer within

previous 5 years Presence of Hepatitis B, Hepatitis C, HIV, systemic lupus erythematosis, presence of transcutaneous access (external catheter)

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

Starting date: March 2005
Ending date: March 2007
Last updated: December 26, 2007