Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-25 @ 2:37 AM
Study NCT ID:
NCT00642304
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2008-03-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C508420', 'term': 'continuous erythropoietin receptor activator'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Week 28', 'eventGroups': [{'id': 'EG000', 'title': 'Methoxy Polyethylene Glycol-epoetin Beta', 'description': 'Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.', 'otherNumAtRisk': 20, 'otherNumAffected': 17, 'seriousNumAtRisk': 20, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood calcium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood phosphorus increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Keratoacanthoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urinary bladder haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood Potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haemodialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Renal transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methoxy Polyethylene Glycol-epoetin Beta', 'description': 'Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '64.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EEP (Weeks 16 to 24)', 'description': 'The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent- to -treat (ITT) population included all participants who received at least one dose of trial medication at Week 0 and for whom data for at least one follow-up variable (adverse event) was available.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Hb Concentration Between SVP and the EEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methoxy Polyethylene Glycol-epoetin Beta', 'description': 'Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '1.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)', 'description': 'The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methoxy Polyethylene Glycol-epoetin Beta', 'description': 'Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '27.2', 'upperLimit': '72.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EEP (Weeks 16 to 24)', 'description': 'The EEP was defined as Week 16 to Week 24.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methoxy Polyethylene Glycol-epoetin Beta', 'description': 'Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'spread': '24.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'EEP (Weeks 16 to 24)', 'description': 'The EEP was defined as Week 16 to Week 24.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Blood Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methoxy Polyethylene Glycol-epoetin Beta', 'description': 'Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 28', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Dose Adjustment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methoxy Polyethylene Glycol-epoetin Beta', 'description': 'Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 20', 'description': 'A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methoxy Polyethylene Glycol-epoetin Beta', 'description': 'Methoxy polyethylene glycol-epoetin beta was administered subcutaneously (SC) every four weeks up to Week 20. The starting dose was 120, 200 or 300 micrograms (mcg) based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the hemoglobin (Hb) levels.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Blood transfusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Erythropoiesis Stimulating Agent Use.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Transplantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Methoxy Polyethylene Glycol-epoetin Beta', 'description': 'Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'spread': '16.83', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who received at least one dose trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2009-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2008-03-19', 'resultsFirstSubmitDate': '2016-09-16', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-16', 'studyFirstPostDateStruct': {'date': '2008-03-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)', 'timeFrame': 'EEP (Weeks 16 to 24)', 'description': 'The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.'}], 'secondaryOutcomes': [{'measure': 'Mean Change in Hb Concentration Between SVP and the EEP', 'timeFrame': 'SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)', 'description': 'The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.'}, {'measure': 'Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP', 'timeFrame': 'EEP (Weeks 16 to 24)', 'description': 'The EEP was defined as Week 16 to Week 24.'}, {'measure': 'Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP', 'timeFrame': 'EEP (Weeks 16 to 24)', 'description': 'The EEP was defined as Week 16 to Week 24.'}, {'measure': 'Percentage of Participants With Blood Transfusion', 'timeFrame': 'Baseline up to Week 28'}, {'measure': 'Percentage of Participants With Dose Adjustment', 'timeFrame': 'Baseline up to Week 20', 'description': 'A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms \\[mcg\\] subcutaneously \\[SC\\]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic renal anemia\n* Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks\n\nExclusion Criteria:\n\n* Transfusion of red blood cells during previous 8 weeks\n* Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months\n* Acute or chronic bleeding requiring therapy within previous 8 weeks'}, 'identificationModule': {'nctId': 'NCT00642304', 'briefTitle': 'A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously C.E.R.A. for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis', 'orgStudyIdInfo': {'id': 'ML20937'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'methoxy polyethylene glycol-epoetin beta', 'interventionNames': ['Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]']}], 'interventions': [{'name': 'methoxy polyethylene glycol-epoetin beta [C.E.R.A.]', 'type': 'DRUG', 'description': 'Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.', 'armGroupLabels': ['methoxy polyethylene glycol-epoetin beta']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7609 PP', 'city': 'Almelo', 'country': 'Netherlands', 'facility': 'Twenteborg Ziekenhuis', 'geoPoint': {'lat': 52.35667, 'lon': 6.6625}}, {'zip': '3818 ES', 'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'zip': '1034 CS', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Bovenij Zkhs; Cardiologie Afd.', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9401 RK', 'city': 'Assen', 'country': 'Netherlands', 'facility': 'Wilhelmina Ziekenhuis; Inwendige Geneeskunde', 'geoPoint': {'lat': 52.99667, 'lon': 6.5625}}, {'zip': '1942LE', 'city': 'Beverwijk', 'country': 'Netherlands', 'facility': 'Rode Kruis Ziekenhuis; Inwendige Geneeskunde', 'geoPoint': {'lat': 52.48333, 'lon': 4.65694}}, {'zip': '4819 EV', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '2625 AD', 'city': 'Delft', 'country': 'Netherlands', 'facility': 'Reinier De Graaf Groep', 'geoPoint': {'lat': 52.00667, 'lon': 4.35556}}, {'zip': '7009 BL', 'city': 'Doetinchem', 'country': 'Netherlands', 'facility': 'Slingeland Ziekenhuis; Inwendige Geneeskunde', 'geoPoint': {'lat': 51.965, 'lon': 6.28889}}, {'zip': '3318 AT', 'city': 'Dordrecht', 'country': 'Netherlands', 'facility': 'Albert Schweitzer Ziekenhuis; Inwendige Geneeskunde', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'zip': '9202 NN', 'city': 'Drachten', 'country': 'Netherlands', 'facility': 'Nij Smellinghe Ziekenhuis; Inwendige Geneeskunde', 'geoPoint': {'lat': 53.11254, 'lon': 6.0989}}, {'zip': '4462 RA', 'city': 'Goes', 'country': 'Netherlands', 'facility': 'Oosterscheldeziekenhuis', 'geoPoint': {'lat': 51.50417, 'lon': 3.88889}}, {'zip': '2803 HH', 'city': 'Gouda', 'country': 'Netherlands', 'facility': 'Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'zip': '6419 PC', 'city': 'Heerlen', 'country': 'Netherlands', 'facility': 'Atrium Medisch Centrum; Nephrology', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'zip': '7909', 'city': 'Hoogeveen', 'country': 'Netherlands', 'facility': 'Bethesda Hospital; Internal Medicine', 'geoPoint': {'lat': 52.7225, 'lon': 6.47639}}, {'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center; Nierziekten', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '2353 GA', 'city': 'Leiderdorp', 'country': 'Netherlands', 'facility': 'Rijnland Zkhs Loc Leiderdorp; Interne geneeskunde', 'geoPoint': {'lat': 52.15833, 'lon': 4.52917}}, {'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '6525 GA', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis St. Radboud; Nierziekten Afd.', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Mc - Locatie Centrum; Inwendige Geneeskunde', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3078 HT', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Mc Rijnmond Zuid - Locatie Clara; Infectieziekten', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3083 AN', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Ikazia Ziekenhuis; Interne Oncologie', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '4535 PA', 'city': 'Terneuzen', 'country': 'Netherlands', 'facility': 'Zorgsaam Ziekenhuis', 'geoPoint': {'lat': 51.33583, 'lon': 3.82778}}, {'zip': '3582 KE', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Diakonessenhuis', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}