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

Phase 2

Terminated

• Conditions: End Stage Renal Disease
• Interventions: Drug: Placebo; Drug: Etanercept

• Registration Number: NCT00293202
• Lead Sponsor: Kaysen, George A., M.D., Ph.D.

Brief 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.

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 Timeline

• Study Start: 2005-01
• Study First Submitted: 2006-02-15
• Study First Submitted QC: 2006-02-15
• Study First Posted: 2006-02-17
• Primary Completion: 2008-03
• Study Completion: 2010-06
• Results First Submitted: 2021-02-25
• Results First Submitted QC: 2021-05-05
• Results First Posted: 2021-05-28
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Placebo	Saline injection twice a week
Etanercept 25 mg	Etanercept	Etanercept 25 mg injection twice a week

Primary Outcome Measures

Name	Time	Method
C-reactive Protein	52 weeks	A reduced C-reactive protein (CRP) concentration is expected.
Albumin	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.

Secondary Outcome Measures

Name	Time	Method
Prealbumin (mg/dL)	52 weeks	Effect of treatment on prealbumin (PAB) concentration

Trial Locations

Locations (1)

University of California, Davis, Medical Center; 🇺🇸 Sacramento, California, United States