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We were unable to recruit sufficient patients within the confines of our budget considering the restrains on our recruitment criteria
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
| Dialysis Clinic, Inc. | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept 25 mg | Active Comparator | Etanercept 25 mg injection twice a week |
|
| Saline | Placebo Comparator | Saline injection twice a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prealbumin (mg/dL) | Effect of treatment on prealbumin (PAB) concentration | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Kaysen, MD, PhD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis, Medical Center | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20497755 | Result | 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. |
| Label | URL |
|---|---|
| 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 | View source |
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Subject was consented and screened for safety. Then they have to qualify for 3 monthly screening values. Once deemed qualified for the study, subject then randomized into a double-blind study; to follow regimen of protocols and followed to 52 weeks of study.
The protocol was approved by the Human Subjects Review Committee of the University of California Davis Medical Center and Dialysis Clinics, Incorporated. Screening started in January 2005, and had to be terminated early due to low enrollment in December 2006
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Active Comparator: Etanercept 25 mg injection twice a week
|
| FG001 | Placebo | Placebo comparator: Saline injection twice a week
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Total number of participant in each group
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Etanercept 25 mg injection twice a week Etanercept: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Hemodialysis patients have a high mortality rate caused by poor nutrition and inflammation. The hypothesis is that suppression of inflammation reverses the malnutrition-inflammation syndrome in hemodialysis patients. Etanercept is an anti-inflammatory agent. Thus it is expected that participant given Etanercept will have a reduced amount of inflammation in their bodies and have better nutritional status - indicated by an increase/steady Albumin level. | Posted | Mean | Standard Deviation | g/dL | 52 weeks |
|
12 months
Adverse Event collected was in the same category as defined
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept | Etanercept 25 mg injection twice a week Etanercept: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epigastric pain | Gastrointestinal disorders | MedDRA | Systematic Assessment | Nausea, vomiting, constipation, and epigastric pain initially thought to be pancreatitis, but later found to be either gastroenteritis or peptic ulcer disease -Not related to Study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin pain | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Burning pain in hands -Not related to Study |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Kaysen MD PhD | University of California, Davis | 916-734-3774 | gakaysen@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2021 | Jun 14, 2021 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D044342 | Malnutrition |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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This is a double blind study- one group received 25mg Etanercept twice per week; the other is control - receiving saline twice per week
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Double Blind Study
| Placebo | Drug | Hemodialysis patients will receive Saline by subcutaneous injection twice a week |
|
|
| on-hold due to fistula maturation time |
|
Saline injection twice a week
Placebo: Hemodialysis patients will receive Saline by subcutaneous injection twice a week
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participant |
|
| C-Reactive Protein (CRP) | C-Reactive Protein is serum protein measured in milligram per liter (mg/L). Increase number indicate higher level of inflammation | Mean | Standard Deviation | mg/L |
|
| Albumin | Serum Albumin is measured in gram per deciliter (g/dL). Increase number is a measured of better nutritional status | Mean | Standard Deviation | g/dL |
|
| OG001 | Placebo | No Drug: Saline injection twice a week Hemodialysis patients will receive Saline by subcutaneous injection twice a week for a total of 52 weeks |
|
|
| Primary | C-reactive Protein | A reduced C-reactive protein (CRP) concentration is expected. | Malnutrition, inflammation, and atherosclerosis affect patients with chronic renal failure. High C-reactive protein is a marker of inflammation. This study is designed to examine whether suppression of the inflammatory response can be accomplished safely with Etanercept. For those who has high CRP level, we expect that CRP level will be reduced | Posted | Mean | Standard Deviation | mg/L | 52 weeks |
|
|
|
| Secondary | Prealbumin (mg/dL) | Effect of treatment on prealbumin (PAB) concentration | Serum Prealbumin is measured in milligram per deciliter (mg/dL). Increase number is a measured of better nutritional status. In the etanercept group we would expect fewer decreases in prealbumin. Decreased level of prealbumin may indicate inflammations may be occurring in the body. | Posted | Mean | Standard Deviation | mg/dL | 52 weeks |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | Placebo | Saline injection twice a week Placebo: Hemodialysis patients will receive Saline by subcutaneous injection twice a week | 0 | 5 | 3 | 5 | 1 | 5 |
|
| Stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Stroke, considered related to elective catheterization to evaluate for kidney transplant, due to development of memory loss and left leg weakness (following ventricular fibrillation during catheterization) -not related to Study |
|
| CABG | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | Coronary artery disease syndrome resulting in 3-vessel CABG - not related to Study |
|
| Ventricular Fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | Ventricular fibrillation during elective cardiac catheterization for kidney transplant evaluation - Not related to Study |
|
|
| Cold symptoms | General disorders | MedDRA (Unspecified) | Systematic Assessment | Fever, cough, chest congestion -Unlikely related to Study |
|
| Hematuria, chest pain, nausea and vomiting | General disorders | MedDRA (Unspecified) | Systematic Assessment | Hematuria, chest pain, nausea and vomiting - Not related to Study |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |