Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT00293202
Status:
TERMINATED
Last Update Posted:
2021-07-13
First Post:
2006-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gakaysen@ucdavis.edu', 'phone': '916-734-3774', 'title': 'George Kaysen MD PhD', 'organization': 'University of California, Davis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'Adverse Event collected was in the same category as defined', 'eventGroups': [{'id': 'EG000', 'title': 'Etanercept', 'description': 'Etanercept 25 mg injection twice a week\n\nEtanercept: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Saline injection twice a week\n\nPlacebo: Hemodialysis patients will receive Saline by subcutaneous injection twice a week', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Skin pain', 'notes': 'Burning pain in hands\n\n-Not related to Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cold symptoms', 'notes': 'Fever, cough, chest congestion\n\n-Unlikely related to Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hematuria, chest pain, nausea and vomiting', 'notes': 'Hematuria, chest pain, nausea and vomiting\n\n\\- Not related to Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Epigastric pain', 'notes': 'Nausea, vomiting, constipation, and epigastric pain initially thought to be pancreatitis, but later found to be either gastroenteritis or peptic ulcer disease\n\n-Not related to Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stroke', 'notes': '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)\n\n-not related to Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'CABG', 'notes': 'Coronary artery disease syndrome resulting in 3-vessel CABG\n\n\\- not related to Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ventricular Fibrillation', 'notes': 'Ventricular fibrillation during elective cardiac catheterization for kidney transplant evaluation\n\n\\- Not related to Study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Active comparator: Etanercept 25 mg injection twice a week\n\nHemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week for a total of 52 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'No Drug: Saline injection twice a week\n\nHemodialysis patients will receive Saline by subcutaneous injection twice a week for a total of 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.34', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '3.42', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': '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.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Active comparator: Etanercept 25 mg injection twice a week\n\nHemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week for a total of 52 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'No Drug - Saline injection twice a week\n\nHemodialysis patients will receive Saline by subcutaneous injection twice a week for a total of 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '28.96', 'spread': '26.00', 'groupId': 'OG000'}, {'value': '11.94', 'spread': '13.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'A reduced C-reactive protein (CRP) concentration is expected.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Prealbumin (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 25 mg', 'description': 'Etanercept 25 mg injection twice a week\n\nEtanercept: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Saline injection twice a week\n\nPlacebo: Hemodialysis patients will receive Saline by subcutaneous injection twice a week'}], 'classes': [{'categories': [{'measurements': [{'value': '32.36', 'spread': '8.64', 'groupId': 'OG000'}, {'value': '31.43', 'spread': '8.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Effect of treatment on prealbumin (PAB) concentration', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Serum Prealbumin is measured in milligram per deciliter (mg/dL). Increase number is a measured of better nutritional status.\n\nIn the etanercept group we would expect fewer decreases in prealbumin. Decreased level of prealbumin may indicate inflammations may be occurring in the body.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etanercept', 'description': 'Active Comparator: Etanercept 25 mg injection twice a week\n\n1. 5 Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week\n2. Do not have active infections\n3. Patient will be followed for 52 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo comparator: Saline injection twice a week\n\n1. 5 Hemodialysis patients will receive Saline by subcutaneous injection twice a week\n2. Do not have active infections\n3. Patient will be followed for 52 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'positive ANA (antinuclear antibody)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'on-hold due to fistula maturation time', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept', 'description': 'Etanercept 25 mg injection twice a week\n\nEtanercept: Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Saline injection twice a week\n\nPlacebo: Hemodialysis patients will receive Saline by subcutaneous injection twice a week'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '16.739', 'groupId': 'BG000'}, {'value': '55', 'spread': '15.209', 'groupId': 'BG001'}, {'value': '53', 'spread': '15.101', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participant'}, {'title': 'C-Reactive Protein (CRP)', 'classes': [{'categories': [{'measurements': [{'value': '29.05', 'spread': '15.60', 'groupId': 'BG000'}, {'value': '10.98', 'spread': '3.95', 'groupId': 'BG001'}, {'value': '15.79', 'spread': '28.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'C-Reactive Protein is serum protein measured in milligram per liter (mg/L). Increase number indicate higher level of inflammation', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Albumin', 'classes': [{'categories': [{'measurements': [{'value': '3.39', 'spread': '0.24', 'groupId': 'BG000'}, {'value': '3.31', 'spread': '0.21', 'groupId': 'BG001'}, {'value': '3.37', 'spread': '0.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Serum Albumin is measured in gram per deciliter (g/dL). Increase number is a measured of better nutritional status', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Total number of participant in each group'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-09', 'size': 111201, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-14T15:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double Blind Study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a double blind study- one group received 25mg Etanercept twice per week; the other is control - receiving saline twice per week'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'We were unable to recruit sufficient patients within the confines of our budget considering the restrains on our recruitment criteria', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2006-02-15', 'resultsFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2006-02-15', 'lastUpdatePostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-05', 'studyFirstPostDateStruct': {'date': '2006-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Albumin', 'timeFrame': '52 weeks', 'description': '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.'}, {'measure': 'C-reactive Protein', 'timeFrame': '52 weeks', 'description': 'A reduced C-reactive protein (CRP) concentration is expected.'}], 'secondaryOutcomes': [{'measure': 'Prealbumin (mg/dL)', 'timeFrame': '52 weeks', 'description': 'Effect of treatment on prealbumin (PAB) concentration'}]}, 'conditionsModule': {'keywords': ['etanercept', 'malnutrition', 'inflammation', 'hemodialysis'], 'conditions': ['End Stage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '20497755', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/20497755/', 'label': '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'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of end stage renal disease\n\nExclusion Criteria:\n\n* 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)'}, 'identificationModule': {'nctId': 'NCT00293202', 'briefTitle': 'Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kaysen, George A., M.D., Ph.D.'}, 'officialTitle': 'The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '200311904'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Etanercept 25 mg', 'description': 'Etanercept 25 mg injection twice a week', 'interventionNames': ['Drug: Etanercept']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Saline injection twice a week', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Etanercept', 'type': 'DRUG', 'otherNames': ['Enbrel'], 'description': 'Hemodialysis patients will receive Etanercept at a dose of 25 mg by subcutaneous injection twice a week', 'armGroupLabels': ['Etanercept 25 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'Hemodialysis patients will receive Saline by subcutaneous injection twice a week', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis, Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'George Kaysen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaysen, George A., M.D., Ph.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}, {'name': 'Dialysis Clinic, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'George A. Kaysen, M.D., Ph.D.', 'investigatorAffiliation': 'Kaysen, George A., M.D., Ph.D.'}}}}