Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients
Information source: Kaysen, George A., M.D., Ph.D.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
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
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.
- Presence of end stage renal disease
- 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)
Locations and Contacts
University of California, Davis, Medical Center, Sacramento, California 95817, United States
Starting date: March 2005
Ending date: March 2007
Last updated: December 26, 2007