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

This study has been terminated.
(We were unable to recruit sufficient patients within the confines of our budget)
Sponsor:
Collaborators:
Amgen
Dialysis Clinic, Inc.
Information provided by:
Kaysen, George A., M.D., Ph.D.
ClinicalTrials.gov Identifier:
NCT00293202
First received: February 15, 2006
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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. 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.


Condition Intervention Phase
End Stage Renal Disease
Drug: Etanercept
Drug: Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Kaysen, George A., M.D., Ph.D.:

Primary Outcome Measures:
  • increased serum albumin concentration [ Time Frame: 12 months of treatment ] [ Designated as safety issue: Yes ]
  • reduced C-reactive protein concentration [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • effect of treatment on prealbumin concentration [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: March 2005
Study Completion Date: June 2010
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Etanercept 25 mg injection twice a week
Drug: Etanercept
Hemodialysis patients having a serum albumin of less than or equal to 3.8 g/dl and a CRP greater than or equal to 0.8 mg/dL will receive either etanercept at a dose of 25 mg by subcutaneous injection twice a week or a placebo for a period of 48 weeks. The outcome is an increase in serum albumin and pre-albumin in the treated group.
Other Name: Embrel
Placebo Comparator: B
Saline injection twice a week
Drug: Saline
Saline will be injected subcutaneously twice a week
Other Name: Saline

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00293202

Locations
United States, California
University of California, Davis, Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
Kaysen, George A., M.D., Ph.D.
Amgen
Dialysis Clinic, Inc.
Investigators
Principal Investigator: George Kaysen, MD, PhD University of California, Davis
  More Information

No publications provided by Kaysen, George A., M.D., Ph.D.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George Kaysen PI, University of California Davis
ClinicalTrials.gov Identifier: NCT00293202     History of Changes
Other Study ID Numbers: 200311904
Study First Received: February 15, 2006
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Kaysen, George A., M.D., Ph.D.:
etanercept
malnutrition
inflammation
hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014