Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-06 @ 6:23 PM
Study NCT ID:
NCT00572533
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2007-12-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intelligent Control Approach to Anemia Management
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': 'D000249', 'term': 'Adenosine Monophosphate'}], 'ancestors': [{'id': 'D000227', 'term': 'Adenine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adam.gaweda@louisville.edu', 'phone': '502-852-0766', 'title': 'Adam E Gaweda', 'organization': 'University of Louisville'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '1. Single-center design\n2. Small sample size\n3. Homogenous population\n4. Only maintenance dosing phase tested'}}, 'adverseEventsModule': {'timeFrame': '04/01/2011 - 03/31/2012', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'ESA Dose Adjustment per standard Anemia Management Protocol', 'otherNumAtRisk': 31, 'otherNumAffected': 17, 'seriousNumAtRisk': 31, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Treatment', 'description': 'ESA Dose Adjustment per "Smart Anemia Manager" Algorithm', 'otherNumAtRisk': 31, 'otherNumAffected': 16, 'seriousNumAtRisk': 31, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Vascular Access Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 27, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 38, 'numAffected': 16}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Composite Safety Event (ACM, MI, CVA, CHF)', 'notes': 'All-Cause Mortality, Myocardial Infarction, Cerebrovascular Accident, Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'All-Cause Hospitalization (includes hospitalization due to Composite Safety Event)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 39, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 41, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Hb 10-12 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'ESA Dose Adjustment per standard Anemia Management Protocol'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'ESA Dose Adjustment per "Smart Anemia Manager" Algorithm'}], 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000'}, {'value': '72.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat Analysis, Missing Data Excluded'}, {'type': 'SECONDARY', 'title': 'Percent Hb < 10 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'ESA Dose Adjustment per standard Anemia Management Protocol'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'ESA Dose Adjustment per "Smart Anemia Manager" Algorithm'}], 'classes': [{'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat Analysis, Missing Data Excluded'}, {'type': 'POST_HOC', 'title': 'Transfusion Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'ESA Dose Adjustment per standard Anemia Management Protocol'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'ESA Dose Adjustment per "Smart Anemia Manager" Algorithm'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Number of Transfusion Events', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat, Missing Data Excluded'}, {'type': 'SECONDARY', 'title': 'Percent Hb > 12 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'ESA Dose Adjustment per standard Anemia Management Protocol'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'ESA Dose Adjustment per "Smart Anemia Manager" Algorithm'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}, {'value': '15.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat, Missed Data Excluded'}, {'type': 'SECONDARY', 'title': 'Mean Hb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'ESA Dose Adjustment per standard Anemia Management Protocol'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'ESA Dose Adjustment per "Smart Anemia Manager" Algorithm'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Mean Hemoglobin concentration over follow-up period', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat Analysis, Missing Data Excluded'}, {'type': 'SECONDARY', 'title': 'ESA Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'ESA Dose Adjustment per standard Anemia Management Protocol'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'ESA Dose Adjustment per "Smart Anemia Manager" Algorithm'}], 'classes': [{'categories': [{'measurements': [{'value': '3,033', 'spread': '3,592', 'groupId': 'OG000'}, {'value': '3,704', 'spread': '5,221', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)', 'unitOfMeasure': 'IU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis, Missing Data Excluded'}, {'type': 'POST_HOC', 'title': 'Subjects Receiving Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'ESA Dose Adjustment per standard Anemia Management Protocol'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'ESA Dose Adjustment per "Smart Anemia Manager" Algorithm'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Number of Subjects receiving Transfusion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat, Missing Data Excluded'}, {'type': 'POST_HOC', 'title': 'RBC Units Transfused', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'ESA Dose Adjustment per standard Anemia Management Protocol'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'ESA Dose Adjustment per "Smart Anemia Manager" Algorithm'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Total number of RBC units transfused', 'unitOfMeasure': 'RBC Units', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat, Missing Data Excluded'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'ESA Dose Adjustment per standard Anemia Management Protocol'}, {'id': 'FG001', 'title': 'Treatment', 'description': 'ESA Dose Adjustment per "Smart Anemia Manager" Algorithm'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Received Kidney Transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Social Issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Transfer out of Facility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'ESA Dose Adjustment per standard Anemia Management Protocol'}, {'id': 'BG001', 'title': 'Treatment', 'description': 'ESA Dose Adjustment per "Smart Anemia Manager" Algorithm'}, {'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': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '10', 'groupId': 'BG000'}, {'value': '57', 'spread': '9', 'groupId': 'BG001'}, {'value': '57', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diabetes', 'classes': [{'title': 'Diabetes', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'No Diabetes', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of subjects with diagnosed diabetes', 'unitOfMeasure': 'Participants'}, {'title': 'Congestive Heart Failure (CHF)', 'classes': [{'title': 'CHF', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'No CHF', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of subjects with diagnosed CHF', 'unitOfMeasure': 'Subjects'}, {'title': 'Vascular Access Type', 'classes': [{'title': 'Fistula', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Catheter', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Graft', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of patients with specific vascular access type', 'unitOfMeasure': 'Participants'}, {'title': 'Hemoglobin (g/dL)', 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '11.3', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '11.3', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Hemoglobin concentration in March 2011', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ESA dose', 'classes': [{'categories': [{'measurements': [{'value': '4,645', 'spread': '7,468', 'groupId': 'BG000'}, {'value': '5,290', 'spread': '7,751', 'groupId': 'BG001'}, {'value': '4,968', 'spread': '7,555', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'ESA dose across group in March 2011', 'unitOfMeasure': 'IU/week/subject', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-15', 'studyFirstSubmitDate': '2007-12-11', 'resultsFirstSubmitDate': '2012-10-15', 'studyFirstSubmitQcDate': '2007-12-11', 'lastUpdatePostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-12-19', 'studyFirstPostDateStruct': {'date': '2007-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Hb 10-12 g/dL', 'timeFrame': '12 months', 'description': 'Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.'}], 'secondaryOutcomes': [{'measure': 'Percent Hb < 10 g/dL', 'timeFrame': '12 months', 'description': 'Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.'}, {'measure': 'Percent Hb > 12 g/dL', 'timeFrame': '12 months', 'description': 'Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.'}, {'measure': 'Mean Hb', 'timeFrame': '12 months', 'description': 'Mean Hemoglobin concentration over follow-up period'}, {'measure': 'ESA Dose', 'timeFrame': '12 months', 'description': 'Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['End-Stage Renal Disease', 'Chronic Hemodialysis'], 'conditions': ['End-Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'First clinical evaluation of "Smart Anemia Manager" algorithm.', 'detailedDescription': 'The purpose of this single-center study is to test whether "Smart Anemia Manager" algorithm improves Hemoglobin stability compared to standard Anemia Management Protocol. Study site: Kidney Disease Program dialysis facility, University of Louisville, Louisville, KY.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. ages 18 to 80,\n2. receiving dialysis treatment,\n3. receiving or expected to receive ESA treatment,\n4. adequacy of dialysis Kt/V \\>= 1.2,\n5. adequate iron stores (Ferritin \\> 200 ng/mL, TSat \\> 20%).\n\nExclusion criteria:\n\n1. life expectancy less than 12 months,\n2. frequent uncontrolled blood loss,\n3. frequent dialyzer clotting,\n4. frequent access related problems,\n5. active infections,\n6. severe cardiac disability,\n7. coronary bypass within three months prior to the study\n8. documented resistance to ESA\n9. bone marrow suppression due to HIV, leukemia, or pharmacologic agents.'}, 'identificationModule': {'nctId': 'NCT00572533', 'briefTitle': 'Intelligent Control Approach to Anemia Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Intelligent Control Approach to Anemia Management (AIM 4)', 'orgStudyIdInfo': {'id': 'K25DK072085', 'link': 'https://reporter.nih.gov/quickSearch/K25DK072085', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'K25DK072085', 'link': 'https://reporter.nih.gov/quickSearch/K25DK072085', 'type': 'NIH'}, {'id': '1K25DK072085-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1K25DK072085-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'ESA Dose Adjustment per standard Anemia Management Protocol', 'interventionNames': ['Other: ESA Dose Adjustment per standard Anemia Management Protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'ESA Dose Adjustment per "Smart Anemia Manager" Algorithm', 'interventionNames': ['Other: ESA Dose Adjustment per "Smart Anemia Manager" Algorithm']}], 'interventions': [{'name': 'ESA Dose Adjustment per standard Anemia Management Protocol', 'type': 'OTHER', 'otherNames': ['AMP'], 'description': 'Amount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility', 'armGroupLabels': ['Control']}, {'name': 'ESA Dose Adjustment per "Smart Anemia Manager" Algorithm', 'type': 'OTHER', 'otherNames': ['SAM'], 'description': 'Amount of ESA dose adjustment in Units per week individualized to subject\'s dose-response profile guided by "Smart Anemia Manager" algorithm', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Kidney Disease Program', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Adam E Gaweda, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Adam Edward Gaweda', 'investigatorAffiliation': 'University of Louisville'}}}}