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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.

Brief 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: Etanercept Drug: Saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients
Study Start Date : March 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arm Intervention/treatment
Active Comparator: A
Etanercept 25 mg injection twice a week
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

Placebo Comparator: B
Saline injection twice a week
Drug: Saline
Saline will be injected subcutaneously twice a week

Primary Outcome Measures :
  1. increased serum albumin concentration [ Time Frame: 12 months of treatment ]
  2. reduced C-reactive protein concentration [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. effect of treatment on prealbumin concentration [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00293202

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United States, California
University of California, Davis, Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
Kaysen, George A., M.D., Ph.D.
Dialysis Clinic, Inc.
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Principal Investigator: George Kaysen, MD, PhD University of California, Davis

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: George Kaysen PI, University of California Davis Identifier: NCT00293202     History of Changes
Other Study ID Numbers: 200311904
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: April 5, 2012
Last Verified: April 2012
Keywords provided by Kaysen, George A., M.D., Ph.D.:
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors