Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-04 @ 2:26 PM
Study NCT ID:
NCT00773968
Status:
COMPLETED
Last Update Posted:
2016-04-04
First Post:
2008-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia
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': 'Hoffman-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': '36 weeks', 'description': 'Safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Methoxy Polyethylene Glycol-Epoetin Beta', 'description': "Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \\<40 µg or 40-80 µg or \\>80 µg, respectively. The doses were adjusted according to individual participant's Hb value.", 'otherNumAtRisk': 111, 'otherNumAffected': 14, 'seriousNumAtRisk': 111, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastritis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methoxy Polyethylene Glycol-Epoetin Beta', 'description': "Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \\<40 µg or 40-80 µg or \\>80 µg, respectively. The doses were adjusted according to individual participant's Hb value."}], 'classes': [{'categories': [{'measurements': [{'value': '65.85', 'groupId': 'OG000', 'lowerLimit': '49.41', 'upperLimit': '79.92'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EEP: Weeks 17 to 28', 'description': 'The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom the data for at least one follow-up variable were available and were without any major protocol violation.'}, {'type': 'SECONDARY', 'title': 'Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methoxy Polyethylene Glycol-Epoetin Beta', 'description': "Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \\<40 µg or 40-80 µg or \\>80 µg, respectively. The doses were adjusted according to individual participant's Hb value."}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.73', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'SVP: Week -4 to Week 0; EEP: Weeks 17 to 28', 'description': 'Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methoxy Polyethylene Glycol-Epoetin Beta', 'description': "Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \\<40 µg or 40-80 µg or \\>80 µg, respectively. The doses were adjusted according to individual participant's Hb value."}], 'classes': [{'categories': [{'measurements': [{'value': '73.17', 'groupId': 'OG000', 'lowerLimit': '57.06', 'upperLimit': '85.78'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EEP: Weeks 17 to 28', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population.'}, {'type': 'SECONDARY', 'title': 'Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methoxy Polyethylene Glycol-Epoetin Beta', 'description': "Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \\<40 µg or 40-80 µg or \\>80 µg, respectively. The doses were adjusted according to individual participant's Hb value."}], 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '86.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'EEP: Weeks 17 to 28', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methoxy Polyethylene Glycol-Epoetin Beta', 'description': "Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \\<40 µg or 40-80 µg or \\>80 µg, respectively. The doses were adjusted according to individual participant's Hb value."}], 'classes': [{'title': 'DTP: Dose Increase Only', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000'}]}]}, {'title': 'DTP: Dose Decrease Only', 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000'}]}]}, {'title': 'DTP: Both Dose Increase and Decrease', 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000'}]}]}, {'title': 'EEP: Dose Increase Only', 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000'}]}]}, {'title': 'EEP: Dose Decrease Only', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'EEP: Both Dose Increase and Decrease', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'DTP: Weeks 1 to 16; EEP: Weeks 17 to 28', 'description': 'The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was \\>1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Required Red Blood Cell Transfusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methoxy Polyethylene Glycol-Epoetin Beta', 'description': "Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \\<40 µg or 40-80 µg or \\>80 µg, respectively. The doses were adjusted according to individual participant's Hb value."}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1 to 28', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methoxy Polyethylene Glycol-Epoetin Beta', 'description': "Participants received methoxy polyethylene glycol-epoetin beta (also known as continuous erythropoietin receptor activator \\[CERA\\]) once monthly by subcutaneous (SC) injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 micrograms (µg) if the last weekly dose of previous erythropoietin stimulating agent (ESA) (darbepoetin alfa) was less than (\\<) 40 µg or 40-80 µg or greater than (\\>) 80 µg, respectively. The doses were adjusted according to individual participant's hemoglobin (Hb) value."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Failure to Return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Methoxy Polyethylene Glycol-Epoetin Beta', 'description': "Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \\<40 µg or 40-80 µg or \\>80 µg, respectively. The doses were adjusted according to individual participant's Hb value."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.1', 'spread': '13.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who entered the study and received at least one dose of methoxy polyethylene glycol-epoetin beta.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-04', 'studyFirstSubmitDate': '2008-10-15', 'resultsFirstSubmitDate': '2016-03-04', 'studyFirstSubmitQcDate': '2008-10-15', 'lastUpdatePostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-04', 'studyFirstPostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)', 'timeFrame': 'EEP: Weeks 17 to 28', 'description': 'The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration).'}], 'secondaryOutcomes': [{'measure': 'Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)', 'timeFrame': 'SVP: Week -4 to Week 0; EEP: Weeks 17 to 28', 'description': 'Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated.'}, {'measure': 'Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP', 'timeFrame': 'EEP: Weeks 17 to 28'}, {'measure': 'Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP', 'timeFrame': 'EEP: Weeks 17 to 28'}, {'measure': 'Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP', 'timeFrame': 'DTP: Weeks 1 to 16; EEP: Weeks 17 to 28', 'description': 'The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was \\>1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.'}, {'measure': 'Percentage of Participants Who Required Red Blood Cell Transfusions', 'timeFrame': 'Weeks 1 to 28'}]}, 'conditionsModule': {'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Participants currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 grams per deciliter (g/dL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic renal anemia;\n* Continuous subcutaneous maintenance darbopoetin alfa treatment during previous month;\n* Hb concentration between 10 and 12 g/dL;\n* Adequate iron status.\n\nExclusion Criteria:\n\n* Transfusion of red blood cells during previous 2 months;\n* Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;\n* Poorly controlled hypertension requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months;\n* Active malignant disease.'}, 'identificationModule': {'nctId': 'NCT00773968', 'acronym': 'ORION', 'briefTitle': 'A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of Subcutaneous C.E.R.A. for the Maintenance of Haemoglobin Levels in Pre-Dialysis Patients With Chronic Renal Anaemia', 'orgStudyIdInfo': {'id': 'ML21439'}, 'secondaryIdInfos': [{'id': '2008-003173-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methoxy Polyethylene Glycol-Epoetin Beta', 'description': 'Participants will receive methoxy polyethylene glycol-epoetin beta once monthly by subcutaneous (SC) injection for 28 weeks.', 'interventionNames': ['Drug: Methoxy Polyethylene Glycol-Epoetin Beta']}], 'interventions': [{'name': 'Methoxy Polyethylene Glycol-Epoetin Beta', 'type': 'DRUG', 'otherNames': ['CERA'], 'description': '120, 200 or 360 micrograms every 4 weeks by subcutaneous injection.', 'armGroupLabels': ['Methoxy Polyethylene Glycol-Epoetin Beta']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70051', 'city': 'Barletta', 'state': 'Apulia', 'country': 'Italy', 'geoPoint': {'lat': 41.31429, 'lon': 16.28165}}, {'zip': '70056', 'city': 'Molfetta (Ba)', 'state': 'Apulia', 'country': 'Italy', 'geoPoint': {'lat': 41.20036, 'lon': 16.59905}}, {'zip': '70017', 'city': 'Putignano', 'state': 'Apulia', 'country': 'Italy', 'geoPoint': {'lat': 40.85106, 'lon': 17.1219}}, {'zip': '81100', 'city': 'Caserta', 'state': 'Campania', 'country': 'Italy', 'geoPoint': {'lat': 41.07262, 'lon': 14.33231}}, {'zip': '84025', 'city': 'Eboli', 'state': 'Campania', 'country': 'Italy', 'geoPoint': {'lat': 40.61747, 'lon': 15.05693}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Campania', 'country': 'Italy', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80035', 'city': 'Nola', 'state': 'Campania', 'country': 'Italy', 'geoPoint': {'lat': 40.92606, 'lon': 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