Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-27 @ 6:13 AM
Study NCT ID:
NCT00882557
Status:
COMPLETED
Last Update Posted:
2018-02-06
First Post:
2009-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Daptomycin Given During Dialysis and After Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017576', 'term': 'Daptomycin'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ed.campanaro@cubist.com', 'phone': '781-860-8318', 'title': 'Ed Campanaro/Vice President, Clinical Operations', 'organization': 'Cubist Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'The first publication is initiated by Cubist. If First Publication not published within 1 year of Study conclusion or termination, Investigator has right to publish and disclose the Data. Prior to any submission for publication, presentation, or communication of results or information arising from the Study, Investigator shall provide Cubist at least 90 days for review and comment upon the manuscript or other material for such publication or presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).', 'description': 'Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests.', 'eventGroups': [{'id': 'EG000', 'title': 'Sequence BA', 'description': 'All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).', 'otherNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sequence AB', 'description': 'All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).', 'otherNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Temporomandibular joint syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluation of Area Under the Curve From Time 0 to Infinity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg/kg After Hemodialysis (Regimen B)', 'description': 'Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes'}, {'id': 'OG001', 'title': '9 mg/kg During Hemodialysis (Regimen A)', 'description': 'Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane'}], 'classes': [{'categories': [{'measurements': [{'value': '1692', 'groupId': 'OG000', 'lowerLimit': '962', 'upperLimit': '2524'}, {'value': '2708', 'groupId': 'OG001', 'lowerLimit': '1719', 'upperLimit': '4010'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)', 'description': 'Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses', 'unitOfMeasure': 'hr*ug/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary endpoints are measured on the PK population, defined as all subjects who received both the 6 mg/kg dose and 9 mg/kg dose'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maximum Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg/kg After Hemodialysis (Regimen B)', 'description': 'Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes'}, {'id': 'OG001', 'title': '9 mg/kg During Hemodialysis (Regimen A)', 'description': 'Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane'}], 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'groupId': 'OG000', 'lowerLimit': '35.8', 'upperLimit': '104'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '56.5', 'upperLimit': '211'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)', 'description': 'Maximum plasma concentration over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population - defined as all subjects who received both doses of daptomycin'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Maximum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg/kg After Hemodialysis (Regimen B)', 'description': 'Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes'}, {'id': 'OG001', 'title': '9 mg/kg During Hemodialysis (Regimen A)', 'description': 'Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '1.00'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '0.65'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 68 hours post dose', 'description': 'Sampling time at which maximum plasma concentration occurred, obtained directly from the experimental plasma concentration time data, without interpolation.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Half-life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg/kg After Hemodialysis (Regimen B)', 'description': 'Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes'}, {'id': 'OG001', 'title': '9 mg/kg During Hemodialysis (Regimen A)', 'description': 'Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000', 'lowerLimit': '19.7', 'upperLimit': '38.1'}, {'value': '31.1', 'groupId': 'OG001', 'lowerLimit': '21.9', 'upperLimit': '45.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 68 hours post dose', 'description': 'Apparent terminal half-life.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clearance of Daptomycin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg/kg After Hemodialysis (Regimen B)', 'description': 'Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes'}, {'id': 'OG001', 'title': '9 mg/kg During Hemodialysis (Regimen A)', 'description': 'Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane'}], 'classes': [{'categories': [{'measurements': [{'value': '3.54', 'groupId': 'OG000', 'lowerLimit': '2.38', 'upperLimit': '6.23'}, {'value': '3.32', 'groupId': 'OG001', 'lowerLimit': '2.24', 'upperLimit': '5.23'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 68 hours post dose', 'description': 'Plasma clearance is dose (µg) divided by area under the concentration versus time curve from time 0 to last quantifiable concentration time.', 'unitOfMeasure': 'mL/hr/kg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population - defined as all subjects who received both doses of daptomycin'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Volume of Distribution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg/kg After Hemodialysis (Regimen B)', 'description': 'Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes'}, {'id': 'OG001', 'title': '9 mg/kg During Hemodialysis (Regimen A)', 'description': 'Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane'}], 'classes': [{'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000', 'lowerLimit': '107', 'upperLimit': '221'}, {'value': '145', 'groupId': 'OG001', 'lowerLimit': '115', 'upperLimit': '219'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 68 hours post dose', 'description': 'Volume of distribution at steady state (mL) calculated as the product of clearance and mean residence time.', 'unitOfMeasure': 'mL/kg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment-emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg/kg After Hemodialysis (Regimen B)', 'description': 'Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes'}, {'id': 'OG001', 'title': '9 mg/kg During Hemodialysis (Regimen A)', 'description': 'Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).', 'description': 'Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population, defined as all subjects who received at least one dose of daptomycin'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence BA', 'description': 'All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).'}, {'id': 'FG001', 'title': 'Sequence AB', 'description': 'All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Completed Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Completed Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Trouble with Vein Access', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomized Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Subjects evaluated for entry within 7 days prior to randomization, washout period of 7-14 days between doses, subjects began Day 1 on Friday of Monday/Wednesday/Friday or Saturday of Tuesday/Thursday/Saturday hemodialysis schedule'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence BA', 'description': 'All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).'}, {'id': 'BG001', 'title': 'Sequence AB', 'description': 'All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '13.19', 'groupId': 'BG000'}, {'value': '55.3', 'spread': '6.05', 'groupId': 'BG001'}, {'value': '53.3', 'spread': '10.31', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Safety population (1 patient included in the overall number of baseline participants in the "Sequence AB" arm was randomized but not treated)', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Safety population (1 patient included in the overall number of baseline participants in the "Sequence AB" arm was randomized but not treated)', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2009-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-10', 'studyFirstSubmitDate': '2009-04-15', 'resultsFirstSubmitDate': '2011-07-19', 'studyFirstSubmitQcDate': '2009-04-15', 'lastUpdatePostDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-09-16', 'studyFirstPostDateStruct': {'date': '2009-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maximum Plasma Concentration', 'timeFrame': 'Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)', 'description': 'Maximum plasma concentration over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation.'}, {'measure': 'Time to Maximum Concentration', 'timeFrame': 'Up to 68 hours post dose', 'description': 'Sampling time at which maximum plasma concentration occurred, obtained directly from the experimental plasma concentration time data, without interpolation.'}, {'measure': 'Half-life', 'timeFrame': 'Up to 68 hours post dose', 'description': 'Apparent terminal half-life.'}, {'measure': 'Clearance of Daptomycin', 'timeFrame': 'Up to 68 hours post dose', 'description': 'Plasma clearance is dose (µg) divided by area under the concentration versus time curve from time 0 to last quantifiable concentration time.'}, {'measure': 'Volume of Distribution', 'timeFrame': 'Up to 68 hours post dose', 'description': 'Volume of distribution at steady state (mL) calculated as the product of clearance and mean residence time.'}], 'primaryOutcomes': [{'measure': 'Evaluation of Area Under the Curve From Time 0 to Infinity', 'timeFrame': 'Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)', 'description': 'Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses'}], 'secondaryOutcomes': [{'measure': 'Treatment-emergent Adverse Events', 'timeFrame': 'Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).', 'description': 'Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['End-stage renal disease', 'hemodialysis', 'chronic renal failure'], 'conditions': ['End-stage Renal Disease', 'Renal Failure Chronic Requiring Hemodialysis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether daptomycin at a higher dose given during the last 30 minutes of a dialysis session is equal to a lower dose of daptomycin given after a dialysis session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent prior to any study-related procedure not part of normal medical care;\n* Male or female ≥ 18 years of age;\n* If female of childbearing potential; willing to practice reliable birth control measures during study treatment and for at least 28 days after study completion, not lactating or pregnant, and has a documented negative pregnancy test result within 24 hours prior to study medication administration;\n* End-stage renal disease on stable (for at least 2 weeks) hemodialysis regimen, three times weekly using high-flux membranes;\n* Functioning hemodialysis access (for example, graft or fistula);\n* Considered to be in appropriate health for study entry by the Investigator (for example, no acute, debilitating medical problems) and appropriate candidate for completing study treatment;\n* If taking concomitant medications, subject must be on a relatively stable dose for at least two weeks prior to study drug administration.\n\nExclusion Criteria:\n\n* Received an investigational drug (including experimental biologic agents) within 30 days of study drug administration;\n* Has received any dose of daptomycin within 7 days prior to study drug administration;\n* Known to be allergic or intolerant to daptomycin;\n* Evidence of active ongoing infection;\n* Known human immunodeficiency virus (HIV) infection with CD4 count ≤ 200 cells/mm3;\n* Active illicit drug use or alcohol abuse;\n* Myocardial infarction within last 6 months;\n* Subject with a history of muscular disease (for example, polymyositis, muscular dystrophy);\n* Subject with a history of neurological disease (for example, Guillain Barré, multiple sclerosis), except stroke \\> 6 months prior to study entry;\n* Intramuscular injection within 7 days of study drug administration;\n* Body mass index (BMI) ≤ 18.5 or ≥ 40 kg/m2 (BMI = weight \\[kg\\]/height \\[m2\\]);\n* WBC ≥ 12, 000 cells/mm3 or ≤ 2500 cells/ mm3;\n* Neutropenic subject with absolute neutrophil count ≤ 500 cells/mm3;\n* Baseline CPK values ≥ 3X ULN (upper limit of normal);\n* Alanine aminotransferase (ALT) \\> 5XULN;\n* Aspartate aminotransferase (AST) \\> 5XULN;\n* Hemoglobin ≤ 9 gm/dL;\n* Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations;\n* History of rhabdomyolysis.'}, 'identificationModule': {'nctId': 'NCT00882557', 'briefTitle': 'Study to Evaluate Daptomycin Given During Dialysis and After Dialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}, 'officialTitle': 'A Prospective, Randomized, Crossover-design Study to Evaluate the Pharmacokinetics and Safety of Daptomycin Administered at 9 mg/kg During and 6 mg/kg After Hemodialysis', 'orgStudyIdInfo': {'id': '3009-027'}, 'secondaryIdInfos': [{'id': 'DAP-RENID-08-06', 'type': 'OTHER', 'domain': 'Cubist Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': '9 mg/kg of daptomycin administered during the last 30 minutes of a hemodialysis session.', 'interventionNames': ['Drug: daptomycin']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Post dialysis dosing', 'interventionNames': ['Drug: daptomycin']}], 'interventions': [{'name': 'daptomycin', 'type': 'DRUG', 'otherNames': ['Cubicin'], 'description': 'intradialytic: 9 mg/kg during the last 30 minutes of dialysis', 'armGroupLabels': ['A']}, {'name': 'daptomycin', 'type': 'DRUG', 'otherNames': ['Cubicin'], 'description': '6 mg/kg administered after a hemodialysis session', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Clinical Trials', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'DaVita Clinical Research', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Alistair Wheeler, MD, MFPM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}