Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients

Study Overview
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Brief Summary
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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
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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
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The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Drug: Etanercept
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Etanercept 25 mg<br>Etanercept 25 mg injection twice a week | Drug: Etanercept<br>* Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week<br>* Other names: Enbrel;|
| Placebo Comparator: Saline<br>Saline injection twice a week | Drug: Placebo<br>* Hemodialysis patients will receive Saline by subcutaneous injection twice a week<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Albumin | 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. | 52 weeks | 
| C-reactive Protein | A reduced C-reactive protein (CRP) concentration is expected. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prealbumin (mg/dL) | Effect of treatment on prealbumin (PAB) concentration | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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etanercept, malnutrition, inflammation, hemodialysis