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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-06-30

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.

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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.

Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a double blind study- one group received 25mg Etanercept twice per week; the other is control - receiving saline twice per week

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double Blind Study

Study Groups

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Etanercept 25 mg

Etanercept 25 mg injection twice a week

Group Type ACTIVE_COMPARATOR

Etanercept

Intervention Type DRUG

Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week

Saline

Saline injection twice a week

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Hemodialysis patients will receive Saline by subcutaneous injection twice a week

Interventions

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Etanercept

Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week

Intervention Type DRUG

Placebo

Hemodialysis patients will receive Saline by subcutaneous injection twice a week

Intervention Type DRUG

Other Intervention Names

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Enbrel Saline

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No