Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT01318512
Status:
COMPLETED
Last Update Posted:
2017-07-05
First Post:
2011-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis
Sponsor:
Organization:
Raw JSON
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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': '3.5 years', 'eventGroups': [{'id': 'EG000', 'title': 'Chronic Kidney Disease (CKD)', 'description': 'Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.', 'otherNumAtRisk': 340, 'otherNumAffected': 2, 'seriousNumAtRisk': 340, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Cardiac failure left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Endocarditis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Peripheral arterial disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Post surgical haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 340, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Dose of MIRCERA at Entry Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Kidney Disease (CKD)', 'description': 'Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'spread': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.', 'unitOfMeasure': 'microgram (µg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of MIRCERA during the titration period.'}, {'type': 'SECONDARY', 'title': 'The Mean Hemoglobin (Hb) Level During Titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Kidney Disease (CKD)', 'description': 'Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of haemoglobin.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '93.9', 'spread': '11.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '98.4', 'spread': '12.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '103.4', 'spread': '12.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '106.3', 'spread': '12.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '108.4', 'spread': '12.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, 2, 3, 4', 'description': 'The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. 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[{'measurements': [{'value': '101.3', 'spread': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1', 'description': 'The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.', 'unitOfMeasure': 'microgram (µg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of MIRCERA during titration period.'}, {'type': 'PRIMARY', 'title': 'Average Dose of MIRCERA During Titration Period Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Kidney Disease (CKD)', 'description': 'Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.'}], 'classes': [{'categories': [{'measurements': [{'value': '102.4', 'spread': '54.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 2', 'description': 'The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.', 'unitOfMeasure': 'microgram (µg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of MIRCERA during titration period.'}, {'type': 'PRIMARY', 'title': 'Average Dose of MIRCERA During Titration Period Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Kidney Disease (CKD)', 'description': 'Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.'}], 'classes': [{'categories': [{'measurements': [{'value': '106.1', 'spread': '56.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.', 'unitOfMeasure': 'microgram (µg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of MIRCERA during titration period.'}, {'type': 'PRIMARY', 'title': 'Average Dose of MIRCERA During Titration Period Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Kidney Disease (CKD)', 'description': 'Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.'}], 'classes': [{'categories': [{'measurements': [{'value': '107.5', 'spread': '59.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 4', 'description': 'The average 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reported.', 'unitOfMeasure': 'microgram (µg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of MIRCERA during the maintenance period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chronic Kidney Disease (CKD)', 'description': 'Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.'}], 'periods': [{'title': 'Titration Period (4 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '340'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '340'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Maintenance Period (6 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '340'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '329'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}], 'preAssignmentDetails': 'Study included Titration Period (4 months) and Maintenance Period (6 Months).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Chronic Kidney Disease (CKD)', 'description': 'Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.4', 'spread': '14.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '172', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '168', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants were included.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2011-03-17', 'resultsFirstSubmitDate': '2015-10-29', 'studyFirstSubmitQcDate': '2011-03-17', 'lastUpdatePostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-10-29', 'studyFirstPostDateStruct': {'date': '2011-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Dose of MIRCERA at Entry Level', 'timeFrame': 'Baseline', 'description': 'The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.'}, {'measure': 'Average Dose of MIRCERA During Titration Period Month 1', 'timeFrame': 'Month 1', 'description': 'The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.'}, {'measure': 'Average Dose of MIRCERA During Titration Period Month 2', 'timeFrame': 'Month 2', 'description': 'The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.'}, {'measure': 'Average Dose of MIRCERA During Titration Period Month 3', 'timeFrame': 'Month 3', 'description': 'The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.'}, {'measure': 'Average Dose of MIRCERA During Titration Period Month 4', 'timeFrame': 'Month 4', 'description': 'The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.'}, {'measure': 'Average Dose of MIRCERA During Maintenance Period Month 1', 'timeFrame': 'Month 5 (Maintenance Period Month 1)', 'description': 'The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.'}, {'measure': 'Average Dose of MIRCERA During Maintenance Period Month 2', 'timeFrame': 'Month 6 (Maintenance Period Month 2)', 'description': 'The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.'}, {'measure': 'Average Dose of MIRCERA During Maintenance Period Month 3', 'timeFrame': 'Month 7 (Maintenance Period Month 3)', 'description': 'The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.'}, {'measure': 'Average Dose of MIRCERA During Maintenance Period Month 4', 'timeFrame': 'Month 8 (Maintenance Period Month 4)', 'description': 'The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.'}, {'measure': 'Average Dose of MIRCERA During Maintenance Period Month 5', 'timeFrame': 'Month 9 (Maintenance Period Month 5)', 'description': 'The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.'}, {'measure': 'Average Dose of MIRCERA During Maintenance Period Month 6', 'timeFrame': 'Month 10 (Maintenance Period Month 6)', 'description': 'The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.'}], 'secondaryOutcomes': [{'measure': 'The Mean Hemoglobin (Hb) Level During Titration Period', 'timeFrame': 'Baseline, Month 1, 2, 3, 4', 'description': 'The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA.'}, {'measure': 'The Mean Hemoglobin (Hb) Level During Maintenance Period', 'timeFrame': 'Month 5, 6, 7, 8, 9, 10', 'description': 'The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA'}]}, 'conditionsModule': {'conditions': ['Kidney Disease, Chronic']}, 'descriptionModule': {'briefSummary': 'This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic kidney disease receiving Mircera treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults patients, \\>/=18 years of age\n* Presence of chronic kidney disease (Stage 3-4)\n\nExclusion Criteria:\n\n* Participation in another clinical study'}, 'identificationModule': {'nctId': 'NCT01318512', 'briefTitle': 'An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'The Dosage of MIRCERA in the Treatment of Renal Anaemia in Patients With Chronic Renal Disease Who do Not Undergo Haemodialysis in Clinical Practice', 'orgStudyIdInfo': {'id': 'ML25317'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Kidney Disease', 'description': 'Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of haemoglobin.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '741 11', 'city': 'Nový Jičín', 'country': 'Czechia', 'facility': 'Nemocnice Novy Jicin; Dialyzacni Stredisko', 'geoPoint': {'lat': 49.59438, 'lon': 18.01028}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}