Clinical trial NCT00293202: Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients
Official title: The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: End Stage Renal Disease
Keywords: etanercept
malnutrition
inflammation
hemodialysis
Lead sponsor: Kaysen, George A., M.D., Ph.D.
Sponsor class: OTHER
Collaborators: name: Amgen
name: Dialysis Clinic, Inc.
First posted: 2006-02-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double blind study- one group received 25mg Etanercept twice per week; the other is control - receiving saline twice per week
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Albumin
timeFrame: 52 weeks
measure: C-reactive Protein
timeFrame: 52 weeks
Secondary outcomes:
measure: Prealbumin (mg/dL)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis, Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: George Kaysen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.5414/cnp73431.