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

July 12, 2021 updated by: George A. Kaysen, M.D., Ph.D., Kaysen, George A., M.D., Ph.D.

The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis, Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Etanercept 25 mg
Etanercept 25 mg injection twice a week
Drug: Etanercept
Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week
Other Names:
  • Enbrel
Placebo Comparator: Saline
Saline injection twice a week
Drug: Placebo
Hemodialysis patients will receive Saline by subcutaneous injection twice a week
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaysen, George A., M.D., Ph.D.

Collaborators

Amgen
Dialysis Clinic, Inc.

Investigators

  • Principal Investigator: George Kaysen, MD, PhD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 15, 2006

First Submitted That Met QC Criteria

February 15, 2006

First Posted (Estimate)

February 17, 2006

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200311904

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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