Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-31 @ 2:51 PM
Study NCT ID:
NCT01677767
Status:
COMPLETED
Last Update Posted:
2017-07-05
First Post:
2012-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'global.trial_information@roche.com', 'phone': '+41 616878333', 'title': 'Roche Trial Information Hotline', 'organization': 'F. Hoffmann-La Roche AG'}, '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 Week 24', 'description': 'An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'eventGroups': [{'id': 'EG000', 'title': 'C.E.R.A.', 'description': 'Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.', 'otherNumAtRisk': 124, 'otherNumAffected': 21, 'seriousNumAtRisk': 124, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'notes': 'General Disorders And Administrations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'notes': 'General Disorders And Administrations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'notes': 'General Disorders And Administrations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'notes': 'General Disorders And Administrations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Age of Participants Treated With C.E.R.A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A.', 'description': 'Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'spread': '12.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0)', 'description': 'Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25', 'unitOfMeasure': 'Years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants enrolled into the study.'}, {'type': 'PRIMARY', 'title': 'Mean Weight of Participants Treated With C.E.R.A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A.', 'description': 'Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.44', 'spread': '13.269', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0)', 'description': 'Weight of the participants was measured at the Baseline and summarized with descriptive statistics.', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants enrolled into the study. The analysis population reflects those participants whose weights were assessed at baseline.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Co-morbidity Treated With C.E.R.A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A.', 'description': 'Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.'}], 'classes': [{'title': 'Total comorbid participants', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}, {'title': 'Comorbidity, renal and urinary disorders', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'Comorbidity, vascular disorders', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Comorbidity, metabolism and nutrition disorders', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', 'description': 'Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants enrolled into the study.'}, {'type': 'PRIMARY', 'title': 'Mean Time Required to Achieve Target Hemoglobin Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A.', 'description': 'Participants with Hb less than (\\<) 10 g/dL at enrollment were evaluated for correction of anemia.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.66', 'spread': '5.652', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 24', 'description': 'The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1', 'unitOfMeasure': 'Week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (\\<) 10 g/dL at enrollment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieved Target Range of Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A.', 'description': 'Participants with Hb less than (\\<) 10 g/dL at enrollment were evaluated for correction of anemia.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', 'description': 'The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb \\< 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (\\<) 10 g/dL at enrollment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A.', 'description': 'Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', 'description': 'For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.'}, {'type': 'SECONDARY', 'title': 'Mean Time Spent by Participants in the Hb Target Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A.', 'description': 'Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.54', 'spread': '6.143', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 24', 'description': 'Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.', 'unitOfMeasure': 'Week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Route of Administration for C.E.R.A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A.', 'description': 'Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.'}], 'classes': [{'title': 'Intravenous administration', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Subcutaneous administration', 'categories': [{'measurements': [{'value': '647', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', 'description': 'C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.', 'unitOfMeasure': 'Number of injections', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants enrolled into the study'}, {'type': 'SECONDARY', 'title': 'Evaluation of Dose Per Injection of C.E.R.A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A.', 'description': 'Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'spread': '21.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 24', 'description': 'The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.', 'unitOfMeasure': 'Microgram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants enrolled into the study'}, {'type': 'SECONDARY', 'title': 'Number of Participants Received Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A.', 'description': 'Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', 'description': 'Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants enrolled into the study'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A.', 'description': 'Participants with chronic renal anemia who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', 'description': 'Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'C.E.R.A.', 'description': 'Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Non-compliance by the participants', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'A total of 127 participants were enrolled from 7 centers in India. This study was conducted between 14 April 2011 and 23 September 2013.', 'preAssignmentDetails': 'Out of 127 participants enrolled in the study, 1 participant was enrolled wrongly and data for 2 participants were not available at the study Centre. Therefore, 124 participants were evaluated in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'C.E.R.A.', 'description': 'Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'spread': '12.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '157.83', 'spread': '10.056', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'For mean height of participants n = 112 as height of some participants was not captured.', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intention-to-Treat (ITT) population included all the participants who received at least 1 dose of C.E.R.A and for whom data for at least one follow-up variable was available'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2012-08-30', 'resultsFirstSubmitDate': '2016-01-06', 'studyFirstSubmitQcDate': '2012-08-30', 'lastUpdatePostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-06', 'studyFirstPostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Age of Participants Treated With C.E.R.A', 'timeFrame': 'Baseline (Week 0)', 'description': 'Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25'}, {'measure': 'Mean Weight of Participants Treated With C.E.R.A', 'timeFrame': 'Baseline (Week 0)', 'description': 'Weight of the participants was measured at the Baseline and summarized with descriptive statistics.'}, {'measure': 'Number of Participants With Co-morbidity Treated With C.E.R.A', 'timeFrame': 'Up to Week 24', 'description': 'Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.'}, {'measure': 'Mean Time Required to Achieve Target Hemoglobin Range', 'timeFrame': 'Up to Week 24', 'description': 'The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1'}, {'measure': 'Percentage of Participants Achieved Target Range of Hemoglobin', 'timeFrame': 'Up to Week 24', 'description': 'The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb \\< 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.'}, {'measure': 'Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.', 'timeFrame': 'Up to Week 24', 'description': 'Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study', 'timeFrame': 'Up to Week 24', 'description': 'For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.'}, {'measure': 'Mean Time Spent by Participants in the Hb Target Range', 'timeFrame': 'Up to Week 24', 'description': 'Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.'}, {'measure': 'Evaluation of Route of Administration for C.E.R.A', 'timeFrame': 'Up to Week 24', 'description': 'C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.'}, {'measure': 'Evaluation of Dose Per Injection of C.E.R.A', 'timeFrame': 'Up to Week 24', 'description': 'The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.'}, {'measure': 'Number of Participants Received Concomitant Medications', 'timeFrame': 'Up to Week 24', 'description': 'Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.'}]}, 'conditionsModule': {'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, 18 to 65 years of age, inclusive\n* Patients with chronic kidney disease on dialysis\n* ESA naïve with Hb \\< 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL\n* Adequate irons status as judged by the treating physician\n\nExclusion Criteria:\n\n* Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication\n* Clinically significant concomitant disease or disorder as defined by protocol\n* Clinical suspicion of pure red cell aplasia (PRCA)\n* Planned elective surgery during the study period , except for cataract surgery or vascular access surgery\n* Transfusion of red blood cells in the previous 2 months\n* Pregnant women\n* Contraindications for Mircera according to local prescribing information or as judged by the investigator'}, 'identificationModule': {'nctId': 'NCT01677767', 'briefTitle': 'An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients on Dialysis , Treated According to Routine Clinical Practice', 'orgStudyIdInfo': {'id': 'ML25475'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110060', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Sir Gangaram Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '380005', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'Ahmedabad Dialysis Centre', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '781007', 'city': 'Guwahati', 'country': 'India', 'facility': 'Excel Center', 'geoPoint': {'lat': 26.1844, 'lon': 91.7458}}, {'zip': '600054', 'city': 'Kolkata', 'country': 'India', 'facility': 'ESIS Hospital; Department of Nephrology', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '400083', 'city': 'Mumbai', 'country': 'India', 'facility': 'Vertex Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '110076', 'city': 'New Delhi', 'country': 'India', 'facility': 'Apollo Indraprastha Hospitals; Nephrology', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '411033', 'city': 'Pune', 'country': 'India', 'facility': 'Aditya Birla Memorial Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}