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

NCT00293202 | Terminated Phase 2 Results

• 1 other identifier: 200311904
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

etanercept; malnutrition; inflammation; hemodialysis

Outcome Measures

Primary Outcomes (2)

• 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

• C-reactive Protein

  A reduced C-reactive protein (CRP) concentration is expected.

  52 weeks

Secondary Outcomes (1)

• Prealbumin (mg/dL)

  52 weeks

Study Arms (2)

Etanercept 25 mg

ACTIVE COMPARATOR

Etanercept 25 mg injection twice a week

Drug: Etanercept

Saline

PLACEBO COMPARATOR

Saline injection twice a week

Drug: Placebo

Interventions

Etanercept DRUG

Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week

Also known as: Enbrel

Etanercept 25 mg

Placebo DRUG

Hemodialysis patients will receive Saline by subcutaneous injection twice a week

Also known as: Saline

Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of end stage renal disease

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kaysen, George A., M.D., Ph.D.: lead
• Amgen: collaborator
• Dialysis Clinic, Inc.: collaborator

Study Sites (1)

University of California, Davis, Medical Center

Sacramento, California, 95817, United States

Location

Related 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. doi: 10.5414/cnp73431.

  PMID: 20497755 RESULT

Related 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

MeSH Terms

Conditions

Kidney Failure, Chronic; Malnutrition; Inflammation

Interventions

Etanercept; Sodium Chloride

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Only 10 out of 40 subjects recruited. Only 5 out of 10 subject randomized completed the study. The study has been slow to accrue patients due to the large number and stringent inclusion and exclusion criteria so as to optimize safety. This is due to Etanercept as an anti-inflammatory agent that acts directly on a key regulatory protein in the immune system, tumor necrosis factor α. Extreme stringency was intended to prevent the potential unmasking of latent infection.

Results Point of Contact

• Title: George Kaysen MD PhD
• Organization: University of California, Davis

gakaysen@ucdavis.edu

916-734-3774

Study Officials

• George Kaysen, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double Blind Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a double blind study- one group received 25mg Etanercept twice per week; the other is control - receiving saline twice per week

Study Record Dates

• First Submitted: February 15, 2006
• First Posted: February 17, 2006
• Study Start: January 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2010
• Last Updated: July 13, 2021
• Results First Posted: May 28, 2021

Record last verified: 2021-07

Locations

US (1)