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Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients
This study is ongoing, but not recruiting participants.
First Received: February 15, 2006   Last Updated: December 26, 2007   History of Changes
Sponsors and Collaborators: Kaysen, George A., M.D., Ph.D.
Amgen
Dialysis Clinics, Inc.
Information provided by: Kaysen, George A., M.D., Ph.D.
ClinicalTrials.gov Identifier: NCT00293202
  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 II

MedlinePlus related topics: Dialysis Kidney Failure
Drug Information available for: Etanercept
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients

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
Estimated Study Completion Date: March 2007
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
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.
B: Placebo Comparator
Saline injection twice a week
Drug: Saline
Saline will be injected subcutaneously twice a week

  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
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 Clinics, Inc.
Investigators
Principal Investigator: George Kaysen, MD, PhD University of California, Davis
  More Information

No publications provided

Responsible Party: University of California Davis ( George Kaysen PI )
Study ID Numbers: 200311904
Study First Received: February 15, 2006
Last Updated: December 26, 2007
ClinicalTrials.gov Identifier: NCT00293202     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Renal Insufficiency
Immunologic Factors
Kidney Failure, Chronic
TNFR-Fc fusion protein
Immunosuppressive Agents
Inflammation
Malnutrition
Urologic Diseases
Renal Insufficiency, Chronic
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Kidney Diseases
Analgesics
Antirheumatic Agents
Kidney Failure

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

ClinicalTrials.gov processed this record on May 07, 2009