Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-03 @ 6:50 AM
Study NCT ID:
NCT00529633
Status:
TERMINATED
Last Update Posted:
2018-04-02
First Post:
2007-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034141', 'term': 'Hypoalbuminemia'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D007019', 'term': 'Hypoproteinemia'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013792', 'term': 'Thalidomide'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gakaysen@ucdavis.edu', 'phone': '916-734-3774', 'title': 'George Kaysen MD PhD, Principal Investigator', 'organization': 'University of California, Davis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination -- Study is terminated due to low enrollment of subjects willing to enter this study'}}, 'adverseEventsModule': {'timeFrame': 'weekly up to 24 weeks of active study period', 'description': 'Adverse Event questionnaire was assessed at weekly visit', 'eventGroups': [{'id': 'EG000', 'title': 'Thalidomide', 'description': 'Patients will receive Thalidomide for a period of 24 weeks. Blood will be drawn every 4 weeks for a total of 28 weeks to establish the effect on albumin, prealbumin and CRP.\n\nThalidomide : 100 mg by mouth at night for 4 weeks; 200 mg by mouth at night for 20 weeks', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks.', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in Serum Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thalidomide', 'description': 'This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin'}], 'classes': [{'title': 'week 1', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'week 2', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'week 3', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'week 4', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'week 8', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'week 16', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'week 20', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'week 24', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'week 28', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '3.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 weeks total', 'description': 'Serum albumin in treated patient and control ("no drug") patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety', 'unitOfMeasure': 'g/dL of Albumin', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Difference in Serum CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thalidomide', 'description': 'This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin'}], 'classes': [{'title': 'week 1', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Observation below quantifiable range', 'groupId': 'OG000'}, {'value': '1.76', 'groupId': 'OG001'}]}]}, {'title': 'week 2', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Observation above quantifiable range', 'groupId': 'OG000'}, {'value': '2.07', 'groupId': 'OG001'}]}]}, {'title': 'week 3', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Observation below quantifiable range', 'groupId': 'OG000'}, {'value': '1.76', 'groupId': 'OG001'}]}]}, {'title': 'week 4', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Observation below quantifiable range', 'groupId': 'OG000'}, {'value': '2.29', 'groupId': 'OG001'}]}]}, {'title': 'week 8', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Observation below quantifiable range', 'groupId': 'OG000'}, {'value': '2.87', 'groupId': 'OG001'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Observation above quantifiable range', 'groupId': 'OG000'}, {'value': '2.87', 'groupId': 'OG001'}]}]}, {'title': 'week 16', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Observation below quantifiable range', 'groupId': 'OG000'}, {'value': '3.41', 'groupId': 'OG001'}]}]}, {'title': 'week 20', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Observation above quantifiable range', 'groupId': 'OG000'}, {'value': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'week 24', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Observation above quantifiable range', 'groupId': 'OG000'}, {'value': '6.01', 'groupId': 'OG001'}]}]}, {'title': 'week 28', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Observation below quantifiable range', 'groupId': 'OG000'}, {'value': '3.93', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 weeks total', 'description': 'Serum CRP in treated patient and control ("no drug") patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety', 'unitOfMeasure': 'Mg/L CRP', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Difference in Serum Prealbumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thalidomide', 'description': 'This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin'}], 'timeFrame': '28 weeks total', 'description': 'Serum Prealbumin in treated patient and control ("no drug") patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant data is not available due to no shipping of specimen to analyzing laboratory'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks.\n\nBlood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin. Subject must meet capsule count of \\>85% compliance with regard to medication and/or birth control requirements as outlined in the S.T.E.P.S ® in the first 4 weeks of study program'}, {'id': 'FG001', 'title': 'Thalidomide', 'description': '1. End stage renal disease (ESRD) patients on hemodialysis for at least 3 months\n2. Serum C reactive protein level of ≥ 0.8 mg/dl\n3. Serum albumin \\< 3.8 g/dl (BCG)\n4. Patients will receive Thalidomide for a period of 24 weeks.\n5. Blood will be drawn every 4 weeks for a total of 28 weeks to establish the effect on albumin, prealbumin and CRP\n\nThalidomide : 100 mg by mouth at night for 4 weeks 200 mg by mouth at night for 20 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study has been terminated due to lack of participation. We enrolled 16 subjects according to eligibility. 4 subjects randomized into the study. Two subjects completed the study.', 'preAssignmentDetails': 'Subject enrollment into the "active" study must meet capsule count of \\>85% compliance with regard to medication and/or birth control requirements as outlined in the S.T.E.P.S ® in the first 4 weeks of study program'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Thalidomide', 'description': '1. 12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months\n2. Serum C reactive protein level of ≥ 0.8 mg/dl\n3. Serum albumin \\< 3.8 g/dl (BCG)\n4. Patients will receive Thalidomide for a period of 24 weeks.100 mg by mouth at night for 4 weeks; then if tolerated, Thalidomid will be increased to 200 mg by mouth at night for 20 weeks; for a total of 24 weeks on Thalidomid'}, {'id': 'BG001', 'title': 'Placebo', 'description': '1. 12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months\n2. Serum C reactive protein level of ≥ 0.8 mg/dl\n3. Serum albumin \\< 3.8 g/dl (BCG)\n4. Patients will receive Placebo for a period of 24 weeks.'}, {'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': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Low enrollment -- We could not recruit patients willing to be enrolled', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-06', 'studyFirstSubmitDate': '2007-09-12', 'resultsFirstSubmitDate': '2016-03-25', 'studyFirstSubmitQcDate': '2007-09-12', 'lastUpdatePostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-27', 'studyFirstPostDateStruct': {'date': '2007-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Serum Albumin', 'timeFrame': '28 weeks total', 'description': 'Serum albumin in treated patient and control ("no drug") patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety'}, {'measure': 'Difference in Serum CRP', 'timeFrame': '28 weeks total', 'description': 'Serum CRP in treated patient and control ("no drug") patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety'}, {'measure': 'Difference in Serum Prealbumin', 'timeFrame': '28 weeks total', 'description': 'Serum Prealbumin in treated patient and control ("no drug") patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Inflammation', 'albumin'], 'conditions': ['Hypoalbuminemia']}, 'descriptionModule': {'briefSummary': 'Both malnutrition and inflammation are associated with death in dialysis patients and also with cardiovascular disease. The researchers are testing the idea that inflammation causes malnutrition by using a drug to suppress inflammation in hemodialysis patients to find out whether that will increase blood tests that are associated with malnutrition. The researchers will give hemodialysis patients who have both inflammation and malnutrition either thalidomide or a placebo and compare the effects of treatment on the levels of two proteins in the blood, albumin and prealbumin, that are normally reduced in malnourished patients. Patients who have a serum albumin concentration \\< 3.8 g/dl will be asked to sign consent to have blood drawn prior to dialysis for measurement of CRP (C-reactive protein). Those with CRP values ≥ 0.8 mg/dl will have a second measurement of CRP performed within 2 weeks. Those with two consecutive values of CRP ≥ 0.8 mg/dl will be eligible for enrollment', 'detailedDescription': '4.1 Pre-assignment measurements will include:\n\n1. Patient is eligible for enrollment.\n2. Complete physical examination.\n3. Blood draw at initiation of hemodialysis session\n4. Instruction on birth control methods required.\n5. Subjects who are non-compliant with regard to medication compliance range or birth control requirements as outlined in the S.T.E.P.S.® program will be immediately discontinued from the study\n\n4.2 Detailed description of treatment: Patients who completed the first 4 weeks will be randomized into Treatment group. A total of 24 subjects will be studied; 12 will receive no drug and 12 will receive thalidomide. Subjects randomized to "Active" Treatment arm will receive Placebo (no-drug/sugar pill) ,or thalidomide 100 mg (two 50 mg active capsules) to take at bedtime. Weekly, Subjects will have blood drawn; will undergo a capsule count to establish a compliance range of \\> 85%; will have physical exam with special attention to skin and evaluation of peripheral nervous system for a change in or appearance of sensory neuropathy.\n\nIf somnolence is tolerable (subjects do not have residual somnolence in the morning) the dose will be increased to 200 mg (4 capsules).\n\nPatients who completed 24 weeks of study will have final evaluation at week 28.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. End stage renal disease (ESRD) patients on hemodialysis for at least 3 months.\n2. Serum C reactive protein level of ≥ 0.8 mg/dl.\n3. Serum albumin \\< 3.8 g/dl (BCG).\n4. Signing a written informed consent form.\n5. Willingness and ability to comply with the FDA-mandated S.T.E.P.S ® program.\n6. Age \\> 18 years.\n\nExclusion Criteria:\n\n1. Pregnant and/ or lactating female.\n2. Active infection within the previous 8 weeks requiring administration of antibiotics.\n3. Patients receiving systemic immunosuppressive therapy.\n4. Patients with HIV.'}, 'identificationModule': {'nctId': 'NCT00529633', 'acronym': 'ICM', 'briefTitle': 'The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Phase 3 Study: The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '200614929'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Thalidomide', 'description': '1. 12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months\n2. Serum C reactive protein level of ≥ 0.8 mg/dl\n3. Serum albumin \\< 3.8 g/dl (BCG)\n4. Patients will receive 100mg Thalidomide for a period of 4 weeks; if somnolence tolerated, dosage is increased to 200mg nightly for a period of 20 more weeks -- to total of 24 weeks on Thalidomide.', 'interventionNames': ['Drug: Thalidomide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No Drug', 'description': '1. 12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months\n2. Serum C reactive protein level of ≥ 0.8 mg/dl\n3. Serum albumin \\< 3.8 g/dl (BCG)\n4. Patients will receive Placebo (Sugar pill) for a period of 24 weeks.', 'interventionNames': ['Other: Sugar pill']}], 'interventions': [{'name': 'Thalidomide', 'type': 'DRUG', 'description': 'Thalidomide by mouth at night for a total of 24 weeks', 'armGroupLabels': ['Thalidomide']}, {'name': 'Sugar pill', 'type': 'OTHER', 'otherNames': ['Placebo (no drug)'], 'description': 'Placebo by mouth at night for a total of 24 weeks', 'armGroupLabels': ['No Drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'George A Kaysen, MD Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}, {'name': 'James F. Winchester, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beth Israel Medicial Center New York New York'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George A. Kaysen, M.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beth Israel Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'George A. Kaysen, M.D.', 'investigatorAffiliation': 'University of California, Davis'}}}}