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

• increased serum albumin concentration [ Time Frame: 12 months of treatment ] [ Designated as safety issue: Yes ]
• reduced C-reactive protein concentration [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

• increased serum albumin concentration
• reduced C-reactive protein concentration

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.

• Drug: Etanercept
  Hemodialysis patients having a serum albumin of less than or equal to 3.8 g/dl and a CRP greater than or equal to 0.8 mg/dL will receive either etanercept at a dose of 25 mg by subcutaneous injection twice a week or a placebo for a period of 48 weeks. The outcome is an increase in serum albumin and pre-albumin in the treated group.
  Other Name: Embrel
• Drug: Saline
  Saline will be injected subcutaneously twice a week
  Other Name: Saline

• Active Comparator: A
  Etanercept 25 mg injection twice a week
  Intervention: Drug: Etanercept
• Placebo Comparator: B
  Saline injection twice a week
  Intervention: Drug: Saline

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)

• Amgen
• Dialysis Clinic, Inc.