Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-03-13 @ 7:01 AM
Study NCT ID:
NCT02263833
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2014-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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': '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': 'Up to 4 years', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.', 'eventGroups': [{'id': 'EG000', 'title': 'Overall Participants', 'description': "Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.", 'otherNumAtRisk': 742, 'otherNumAffected': 0, 'seriousNumAtRisk': 742, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 742, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 742, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 742, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Participants', 'description': "Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years."}], 'classes': [{'title': 'Adverse event', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "At physician's discretion, up to 4 years", 'description': 'An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With an Adverse Drug Reaction (ADR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Participants', 'description': "Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years."}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "At physician's discretion, up to 4 years", 'description': 'ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as "definitely related","probably related", "possibly related", and "unknown" by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as "Unexpected". An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of ESA Naïve Participants Having an Increase in Hemoglobin (Hb) Level of at Least 1 g/dL From Baseline and Reaching the Hb Level Greater Than or Equal to (>/=) 11 g/dL Without Red Blood Cell Transfusion', 'timeFrame': 'Up to 4 years', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants on ESA Therapy Who Were Switched to Mircera Having a Hemoglobin Concentration in the Range of 10 to 12 g/dL', 'timeFrame': 'Up to 4 years', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Participants', 'description': "Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were prescribed Mircera either subcutaneously (SC) or intravenously (IV) according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '742'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '742'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In total, 748 participants were enrolled from 27 sites, of which only 742 participants were used for safety and efficacy analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Participants', 'description': "Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'spread': '14.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '376', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '366', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 748}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-29', 'studyFirstSubmitDate': '2014-10-08', 'resultsFirstSubmitDate': '2016-06-17', 'studyFirstSubmitQcDate': '2014-10-08', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-17', 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of ESA Naïve Participants Having an Increase in Hemoglobin (Hb) Level of at Least 1 g/dL From Baseline and Reaching the Hb Level Greater Than or Equal to (>/=) 11 g/dL Without Red Blood Cell Transfusion', 'timeFrame': 'Up to 4 years'}, {'measure': 'Percentage of Participants on ESA Therapy Who Were Switched to Mircera Having a Hemoglobin Concentration in the Range of 10 to 12 g/dL', 'timeFrame': 'Up to 4 years'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event', 'timeFrame': "At physician's discretion, up to 4 years", 'description': 'An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.'}, {'measure': 'Percentage of Participants With an Adverse Drug Reaction (ADR)', 'timeFrame': "At physician's discretion, up to 4 years", 'description': 'ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as "definitely related","probably related", "possibly related", and "unknown" by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as "Unexpected". An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Kidney Disease, Chronic']}, 'descriptionModule': {'briefSummary': "This national study was a post-marketing surveillance study conducted in Korea from 29 August 2008 to 28 August 2012 to meet local regulatory requirements for Mircera (monopegylated-epoetin beta). Prospective participant-based data collection was evaluated for safety/risk assessments and effectiveness. No specific study-related procedures are required. Participants were to be followed up as long as possible at the physician's discretion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with chronic renal anemia regardless of pre-dialysis / dialysis in Korea. Participants who were prescribed Mircera by their physician according to the local Korean Mircera label, for the treatment of anemia associated with chronic kidney disease who require ESA therapy could be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult, aged \\>18 years\n* Participants with stage 3-5 chronic kidney disease and hemodialyzed participants\n* Signed informed consent\n\nExclusion Criteria:\n\n* Current participation in a clinical study'}, 'identificationModule': {'nctId': 'NCT02263833', 'briefTitle': 'An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Post Marketing Surveillance of Mircera®', 'orgStudyIdInfo': {'id': 'ML22560'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Overall Participants', 'description': 'Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were switched to Mircera', 'interventionNames': ['Drug: Mircera']}], 'interventions': [{'name': 'Mircera', 'type': 'DRUG', 'description': 'Participants received Mircera according to individualized physician-prescribed regimen.', 'armGroupLabels': ['Overall Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}