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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00293202
• Other study ID #: 200311904
• Status: Terminated
• Phase: Phase 2
• Start date: January 2005
• Est. completion date: June 2010

Study information

• Verified date: July 2021
• Source: Kaysen, George A., M.D., Ph.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2010
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Etanercept
Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week
• Placebo
Hemodialysis patients will receive Saline by subcutaneous injection twice a week

Locations

Country	Name	City	State
United States	University of California, Davis, Medical Center	Sacramento	California

Sponsors (3)

Lead Sponsor	Collaborator
Kaysen, George A., M.D., Ph.D.	Amgen, Dialysis Clinic, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Don BR, Kim K, Li J, Dwyer T, Alexander F, Kaysen GA. The effect of etanercept on suppression of the systemic inflammatory response in chronic hemodialysis patients. Clin Nephrol. 2010 Jun;73(6):431-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	C-reactive Protein	A reduced C-reactive protein (CRP) concentration is expected.	52 weeks
Secondary	Prealbumin (mg/dL)	Effect of treatment on prealbumin (PAB) concentration	52 weeks

External Links

•   B.R. Don, K.Kim, J. Li, T. Dwyer, F. Alexander and G.A. Kaysen.The effect of etanercept on suppression of the systemic inflammatory response in chronic hemodialysis patients. 2010; 73: 431-438. doi: 10.5414/CNP73431