Abstract

Background: Inflammation strongly predicts all-cause and cardiovascular mortality among dialysis patients. The negative acute-phase proteins, albumin and prealbumin are both inversely associated with mortality. Both albumin and prealbumin levels are decreased by inflammation. We carried out a pilot study to establish whether treatment with the tumor necrosis factor-α receptor antagonist etanercept would be safe and result in improved levels of albumin and prealbumin in inflamed hypoalbuminemic (albumin < 3.8 g/dl, CRP > 8.0 mg/l) prevalent hemodialysis patients. Methods: We excluded patients who had infectious risk (hepatitis C or B positive, HIV positive, purified protein derivative (PPD) positive or having a history of tuberculosis, having a tunneled dialysis catheter) to find patients having both hypoalbuminemia and inflammation. Of 433 less than 6% met the inclusion criteria. 10 patients were randomized to receive etanercept or placebo twice weekly for 44 weeks. Results: There were no adverse infectious events. There was no significant difference for any of the measurements between the two groups. However there was a significant difference in the time-dependent effects of etanercept on prealbumin: increasing 20% in the etanercept group while decreasing in the placebo group. Conclusions: Administration of a TNF-α receptor antagonist appears safe in this selected population, despite the large increase in infectious risk observed in the dialysis patient population. The effect on surrogate markers of inflammation is small.

Author Details

Authors

• B.R. Don¹
• K.Kim²
• J. Li²
• T. Dwyer¹
• F. Alexander¹
• G.A. Kaysen¹,³,⁴

Departments

• ¹ Division of Nephrology, University of California Davis School of Medicine and the UC Davis Medical Center,
• ² Division of Biostatistics, Department of Public Health Sciences, University of California Davis School of Medicine,
• ³ Department of Biochemistry and Molecular Medicine, University of California, School of Medicine, Davis CA, and the
• ⁴ Department of Veterans Affairs Northern California Health Care System, Mather, CA , USA

Address

G.A. Kaysen MD, PhD
Division of Nephrology
Genome and Biomedical Sciences Facility
451 Health Sciences Drive
University of California
Davis, CA 95616, USA
Email: [email protected]

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