Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients
Information source: Kaysen, George A., M.D., Ph.D.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End Stage Renal Disease
Intervention: Etanercept (Drug); Saline (Drug)
Phase: Phase 2
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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
Last updated: April 4, 2012