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Sponsors and Collaborators: |
Kaysen, George A., M.D., Ph.D. Amgen Dialysis Clinics, Inc. |
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Information provided by: | Kaysen, George A., M.D., Ph.D. |
ClinicalTrials.gov Identifier: | NCT00293202 |
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 |
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End Stage Renal Disease |
Drug: Etanercept Drug: Saline |
Phase II |
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 |
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 |
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A: Active Comparator
Etanercept 25 mg injection twice a week
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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.
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B: Placebo Comparator
Saline injection twice a week
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Drug: Saline
Saline will be injected subcutaneously twice a week
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, Davis, Medical Center | |
Sacramento, California, United States, 95817 |
Principal Investigator: | George Kaysen, MD, PhD | University of California, Davis |
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 |
etanercept malnutrition inflammation hemodialysis |
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 |
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 |