Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|---|
|
End Stage Renal Disease |
Drug: Etanercept Drug: Saline |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients |
- increased serum albumin concentration [ Time Frame: 12 months of treatment ] [ Designated as safety issue: Yes ]
- reduced C-reactive protein concentration [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- effect of treatment on prealbumin concentration [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | March 2005 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Etanercept 25 mg injection twice a week
|
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.
Other Name: Embrel
|
|
Placebo Comparator: B
Saline injection twice a week
|
Drug: Saline
Saline will be injected subcutaneously twice a week
Other Name: Saline
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United States, California | |
| University of California, Davis, Medical Center | |
| Sacramento, California, United States, 95817 | |
| Principal Investigator: | George Kaysen, MD, PhD | University of California, Davis |
More Information
No publications provided by Kaysen, George A., M.D., Ph.D.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | George Kaysen PI, University of California Davis |
| ClinicalTrials.gov Identifier: | NCT00293202 History of Changes |
| Other Study ID Numbers: | 200311904 |
| Study First Received: | February 15, 2006 |
| Last Updated: | April 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Kaysen, George A., M.D., Ph.D.:
|
etanercept malnutrition inflammation hemodialysis |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013