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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00293202
Recruitment Status : Terminated (We were unable to recruit sufficient patients within the confines of our budget)
First Posted : February 17, 2006
Last Update Posted : April 5, 2012
Dialysis Clinic, Inc.
Information provided by:
Kaysen, George A., M.D., Ph.D.

February 15, 2006
February 17, 2006
April 5, 2012
March 2005
March 2008   (Final data collection date for primary outcome measure)
  • increased serum albumin concentration [ Time Frame: 12 months of treatment ]
  • reduced C-reactive protein concentration [ Time Frame: 12 months ]
  • increased serum albumin concentration
  • reduced C-reactive protein concentration
Complete list of historical versions of study NCT00293202 on Archive Site
effect of treatment on prealbumin concentration [ Time Frame: 12 months ]
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Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients
The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients
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.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
End Stage Renal Disease
  • 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
  • Active Comparator: A
    Etanercept 25 mg injection twice a week
    Intervention: Drug: Etanercept
  • Placebo Comparator: B
    Saline injection twice a week
    Intervention: Drug: Saline
Don BR, Kim K, Li J, Dwyer T, Alexander F, Kaysen GA. The effect of etanercept on suppression of the systemic inflammatory response in chronic hemodialysis patients. Clin Nephrol. 2010 Jun;73(6):431-8.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2010
March 2008   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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George Kaysen PI, University of California Davis
Kaysen, George A., M.D., Ph.D.
  • Amgen
  • Dialysis Clinic, Inc.
Principal Investigator: George Kaysen, MD, PhD University of California, Davis
Kaysen, George A., M.D., Ph.D.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP