Title
Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients
The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients
Phase
Phase 2Lead Sponsor
University of California, DavisStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
End Stage Renal DiseaseIntervention/Treatment
etanercept sodium chloride ...Study Participants
10Etanercept 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.
Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week
Hemodialysis patients will receive Saline by subcutaneous injection twice a week
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)
| Event Type | Organ System | Event Term | Etanercept | Placebo |
|---|
An increased serum albumin (ALB) concentration expected. Higher concentrations of Albumin indicate better outcome. Normal ranges of Albumin in this study is from 3.5 to 5.5 gram per deciliter (g/dL). We expect ALB to remain or increase in this study.
A reduced C-reactive protein (CRP) concentration is expected.
Effect of treatment on prealbumin (PAB) concentration
