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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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborators:
Amgen
Dialysis Clinic, Inc.
Information provided by:
Kaysen, George A., M.D., Ph.D.

Tracking Information
First Submitted Date  ICMJE February 15, 2006
First Posted Date  ICMJE February 17, 2006
Last Update Posted Date April 5, 2012
Study Start Date  ICMJE March 2005
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2007)
  • increased serum albumin concentration [ Time Frame: 12 months of treatment ]
  • reduced C-reactive protein concentration [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2006)
  • increased serum albumin concentration
  • reduced C-reactive protein concentration
Change History Complete list of historical versions of study NCT00293202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2007)
effect of treatment on prealbumin concentration [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients
Official Title  ICMJE The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE End Stage Renal Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: A
    Etanercept 25 mg injection twice a week
    Intervention: Drug: Etanercept
  • Placebo Comparator: B
    Saline injection twice a week
    Intervention: Drug: Saline
Publications * 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 26, 2007)
10
Original Enrollment  ICMJE
 (submitted: February 15, 2006)
40
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00293202
Other Study ID Numbers  ICMJE 200311904
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party George Kaysen PI, University of California Davis
Study Sponsor  ICMJE Kaysen, George A., M.D., Ph.D.
Collaborators  ICMJE
  • Amgen
  • Dialysis Clinic, Inc.
Investigators  ICMJE
Principal Investigator: George Kaysen, MD, PhD University of California, Davis
PRS Account Kaysen, George A., M.D., Ph.D.
Verification Date April 2012

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