Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-21 @ 6:08 PM
Study NCT ID:
NCT00661505
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2008-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Intravenous Mircera in Hemodialysis Patients 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': 'global.trial_information@roche.com', 'phone': '+41 61 6878333', '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}, 'limitationsAndCaveats': {'description': 'Low number of participants completed the study as per the protocol. Administration of iron (oral/IV) was as per discretion of individual centers; therefore, C.E.R.A. responses have been limited by iron levels too low for efficient erythropoiesis.'}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 28', 'description': 'Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.', 'eventGroups': [{'id': 'EG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).', 'otherNumAtRisk': 131, 'otherNumAffected': 0, 'seriousNumAtRisk': 131, 'seriousNumAffected': 13}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Arteriovenous fistula site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Renal transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'categories': [{'measurements': [{'value': '46.43', 'groupId': 'OG000', 'lowerLimit': '35.47', 'upperLimit': '57.65'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EEP (Week 16 to Week 24)', 'description': 'The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per protocol (PP) population included all participants who received at least one dose C.E.R.A. and underwent a safety follow-up except who had \\< 3 recorded Hb values and had inadequate iron status during EEP, missed C.E.R.A administration during Weeks 16-24, and/or who withdrawn before the end of EEP.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '1.08', '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 The Stability Verification Period (SVP) 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': 'The Intention to treat (ITT) population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable (adverse event) was available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'categories': [{'measurements': [{'value': '51.18', 'groupId': 'OG000', 'lowerLimit': '42.16', 'upperLimit': '60.15'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EEP (Week 16 to Week 24)', 'description': 'The time adjusted average Hb concentration of all the values recorded during the EEP was calculated for each participant. The percentage of participants maintaining their average Hb concentration during the EEP within the Hb concentration range of 10.0-12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available.'}, {'type': 'SECONDARY', 'title': 'Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000', 'lowerLimit': '21.5', 'upperLimit': '51'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'EEP (Week 16 to Week 24)', 'description': 'The Hb concentration was recorded for all the participants during the EEP. The median time spent (in days) by participants in the target range (10.0-12.0 g/dL) during the EEP is presented. The EEP was defined as Week 16 to Week 24.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'categories': [{'measurements': [{'value': '103.5', 'spread': '46.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'EEP (Week 16 to Week 20)', 'description': 'The mean dose of C.E.R.A. required to maintain Hb level between 10.0-12.0 g/dL during the EEP was calculated per participant and then summarized. The EEP was defined as Week 16 to Week 24. However, C.E.R.A. was not administered at the Week 24 visit. Therefore, the time period for calculation of mean C.E.R.A. dose during EEP is from Week 16 to Week 20.', 'unitOfMeasure': 'mcg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'DTP, n = 127', 'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000'}]}]}, {'title': 'EEP, n = 107', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)', 'description': "Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.0 and 12.0 g/dL throughout the dose titration period (DTP) and the EEP (Week 1 to Week 24). The reference Hb value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0).", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'During DTP, n = 127', 'categories': [{'measurements': [{'value': '121.6', 'spread': '47.13', 'groupId': 'OG000'}]}]}, {'title': 'During EEP, n = 107', 'categories': [{'measurements': [{'value': '112.4', 'spread': '76.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)', 'description': 'The mean monthly dose of C.E.R.A. administered during the DTP and EEP was calculated per participant and then summarized.', 'unitOfMeasure': 'mcg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included participants who received at least 1 dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'Change from BL to Week 16, n = 102', 'categories': [{'measurements': [{'value': '-2.02', 'spread': '3.58', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL to Week 24, n = 95', 'categories': [{'measurements': [{'value': '-1.26', 'spread': '3.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from Baseline in erythrocyte mean corpuscular volume (MCV) was calculated as the value at a specific week during the study minus the BL value. The Baseline was defined as Week -4 to Week 0.', 'unitOfMeasure': 'Femtoliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Hematocrit at Week 16 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'Change from BL to Week 16, n = 104', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL to Week 24, n = 99', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Mean change from Baseline (BL) in hematocrit was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.', 'unitOfMeasure': 'percentage of red blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Hemoglobin at Week 16 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'Change from BL to Week 16, n = 104', 'categories': [{'measurements': [{'value': '-0.00', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL to Week 24, n = 98', 'categories': [{'measurements': [{'value': '0.22', 'spread': '1.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in hemoglobin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'Leucocytes, Change from BL to Week 16, n = 102', 'categories': [{'measurements': [{'value': '0.27', 'spread': '2.21', 'groupId': 'OG000'}]}]}, {'title': 'Leucocytes, Change from BL to Week 24, n = 95', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '1.58', 'groupId': 'OG000'}]}]}, {'title': 'Platelet, Change from BL to Week 16, n = 102', 'categories': [{'measurements': [{'value': '2.56', 'spread': '51.21', 'groupId': 'OG000'}]}]}, {'title': 'Platelet, Change from BL to Week 24, n = 96', 'categories': [{'measurements': [{'value': '0.17', 'spread': '55.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in for each parameter (leucocytes and platelet) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.', 'unitOfMeasure': 'Number of cells x 10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Ferritin at Week 16 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'Change from BL to Week 16, n = 93', 'categories': [{'measurements': [{'value': '20.80', 'spread': '283.54', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL to Week 24, n = 75', 'categories': [{'measurements': [{'value': '31.51', 'spread': '385.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in ferritin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.', 'unitOfMeasure': 'microgram/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'Iron, Change from BL to Week 16, n = 98', 'categories': [{'measurements': [{'value': '2.08', 'spread': '6.87', 'groupId': 'OG000'}]}]}, {'title': 'Iron, Change from BL to Week 24, n = 93', 'categories': [{'measurements': [{'value': '1.15', 'spread': '6.07', 'groupId': 'OG000'}]}]}, {'title': 'TIBC, Change from BL to Week 16, n = 84', 'categories': [{'measurements': [{'value': '0.24', 'spread': '7.09', 'groupId': 'OG000'}]}]}, {'title': 'TIBC, Change from BL to Week 24, n = 80', 'categories': [{'measurements': [{'value': '0.05', 'spread': '8.25', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Change from BL to Week 16, n = 2', 'categories': [{'measurements': [{'value': '-20.33', 'spread': '363.80', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Change from BL to Week 24, n = 92', 'categories': [{'measurements': [{'value': '16.73', 'spread': '218.73', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in each parameter \\[iron, total iron binding capacity (TIBC), and creatinine\\] was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.', 'unitOfMeasure': 'micromole/Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'Transferrin, Change from BL to Week 16, n = 33', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.46', 'groupId': 'OG000'}]}]}, {'title': 'Transferrin, Change from BL to Week 24, n = 29', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.32', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Change from BL to Week 16, n = 98', 'categories': [{'measurements': [{'value': '0.13', 'spread': '3.92', 'groupId': 'OG000'}]}]}, {'title': 'Albumin, Change from BL to Week 24, n = 93', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '4.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in each parameter (transferrin and albumin) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.', 'unitOfMeasure': 'gram/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'Change from BL to Week 16, n = 89', 'categories': [{'measurements': [{'value': '4.11', 'spread': '20.35', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL to Week 24, n = 86', 'categories': [{'measurements': [{'value': '2.41', 'spread': '20.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in transferrin saturation (TSAT) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.', 'unitOfMeasure': 'Percentage of TSAT', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'Change from BL to Week 16, n = 88', 'categories': [{'measurements': [{'value': '1.92', 'spread': '20.64', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL to Week 16, n = 81', 'categories': [{'measurements': [{'value': '-1.43', 'spread': '20.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in C-reactive protein was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.', 'unitOfMeasure': 'milligram/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'Phosphate, Change from BL to Week 16, n = 97', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.54', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate, Change from BL to Week 24, n = 94', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Change from BL to Week 16, n = 94', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Change from BL to Week 24, n = 95', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.93', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in each parameter (phosphate and potassium) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.', 'unitOfMeasure': 'millimole/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Weight at Week 16 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'Change from BL to Week 16, n = 103', 'categories': [{'measurements': [{'value': '0.5', 'spread': '4.17', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL to Week 24, n = 100', 'categories': [{'measurements': [{'value': '0.7', 'spread': '4.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in weight was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.', 'unitOfMeasure': 'kilogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'SBP Before Dialysis,Change from BL to W 16,n = 105', 'categories': [{'measurements': [{'value': '2.1', 'spread': '14.94', 'groupId': 'OG000'}]}]}, {'title': 'DBP Before Dialysis,Change from BL to W 16,n = 105', 'categories': [{'measurements': [{'value': '2.4', 'spread': '10.61', 'groupId': 'OG000'}]}]}, {'title': 'SBP Before Dialysis,Change from BL to W 24,n = 101', 'categories': [{'measurements': [{'value': '3.0', 'spread': '15.46', 'groupId': 'OG000'}]}]}, {'title': 'DBP Before Dialysis,Change from BL to W 24,n = 101', 'categories': [{'measurements': [{'value': '2.2', 'spread': '11.24', 'groupId': 'OG000'}]}]}, {'title': 'SBP After Dialysis,Change from BL to W 16, n = 100', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '17.54', 'groupId': 'OG000'}]}]}, {'title': 'DBP After Dialysis,Change from BL to W 16, n = 100', 'categories': [{'measurements': [{'value': '1.7', 'spread': '10.91', 'groupId': 'OG000'}]}]}, {'title': 'SBP After Dialysis,Change from BL to W 24, n = 95', 'categories': [{'measurements': [{'value': '1.0', 'spread': '15.88', 'groupId': 'OG000'}]}]}, {'title': 'DBP After Dialysis, Change from BL to W 24, n = 95', 'categories': [{'measurements': [{'value': '1.8', 'spread': '10.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured before blood sampling and C.E.R.A. administration. Blood pressure was assessed both before and after the dialysis session for participants undergoing hemodialysis. Change from BL in blood pressure was calculated as the value at a specific week (W) during the study minus the BL value. The baseline was defined as Week -4 to Week 0.', 'unitOfMeasure': 'Millimeters of Mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Taking Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'Antibacterials for systemic use', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Vitamins', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Vaccines', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Agents acting on the renin-angiotensin system', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Analgesics', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Antianemic preparations', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Antithrombotic agents', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Drug for acid related disorders', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Mineral supplements', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 28', 'description': 'The number of participants taking different classes of concomitant medications at any time following enrollment into the study is presented.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Adverse Events and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'Number of participants with any AE', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Number of participants with any SAE', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 28', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be 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. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reports of Anti-erythropoietin Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', 'description': 'The number of participants with Anti-epoetin antibodies is presented.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'classes': [{'title': 'During DTP', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'During EEP', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 to Week 24', 'description': 'Red blood cell transfusions were permitted during the DTP and EEP (Week 1 to Week 24) in case of medical need. All participants requiring a blood transfusion were withdrawn from the study. The number of participants who were administered RBC transfusions during the DTP and EEP is presented.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 132 participants were enrolled in this study conducted from 14 May 2008 to 22 June 2010 at 20 centers in Turkey.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.4', 'spread': '13.80', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics are presented for the safety population which included all participants who received at least one dose C.E.R.A. 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': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2010-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-02', 'studyFirstSubmitDate': '2008-04-16', 'resultsFirstSubmitDate': '2016-06-08', 'studyFirstSubmitQcDate': '2008-04-17', 'lastUpdatePostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-06-08', 'studyFirstPostDateStruct': {'date': '2008-04-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period', 'timeFrame': 'EEP (Week 16 to Week 24)', 'description': 'The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion.'}], 'secondaryOutcomes': [{'measure': 'Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period', '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 The Stability Verification Period (SVP) 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 Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period', 'timeFrame': 'EEP (Week 16 to Week 24)', 'description': 'The time adjusted average Hb concentration of all the values recorded during the EEP was calculated for each participant. The percentage of participants maintaining their average Hb concentration during the EEP within the Hb concentration range of 10.0-12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24.'}, {'measure': 'Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period', 'timeFrame': 'EEP (Week 16 to Week 24)', 'description': 'The Hb concentration was recorded for all the participants during the EEP. The median time spent (in days) by participants in the target range (10.0-12.0 g/dL) during the EEP is presented. The EEP was defined as Week 16 to Week 24.'}, {'measure': 'Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period', 'timeFrame': 'EEP (Week 16 to Week 20)', 'description': 'The mean dose of C.E.R.A. required to maintain Hb level between 10.0-12.0 g/dL during the EEP was calculated per participant and then summarized. The EEP was defined as Week 16 to Week 24. However, C.E.R.A. was not administered at the Week 24 visit. Therefore, the time period for calculation of mean C.E.R.A. dose during EEP is from Week 16 to Week 20.'}, {'measure': 'Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period', 'timeFrame': 'DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)', 'description': "Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.0 and 12.0 g/dL throughout the dose titration period (DTP) and the EEP (Week 1 to Week 24). The reference Hb value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0)."}, {'measure': 'Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period', 'timeFrame': 'DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)', 'description': 'The mean monthly dose of C.E.R.A. administered during the DTP and EEP was calculated per participant and then summarized.'}, {'measure': 'Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from Baseline in erythrocyte mean corpuscular volume (MCV) was calculated as the value at a specific week during the study minus the BL value. The Baseline was defined as Week -4 to Week 0.'}, {'measure': 'Mean Change From Baseline in Hematocrit at Week 16 and Week 24', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Mean change from Baseline (BL) in hematocrit was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.'}, {'measure': 'Mean Change From Baseline in Hemoglobin at Week 16 and Week 24', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in hemoglobin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.'}, {'measure': 'Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in for each parameter (leucocytes and platelet) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.'}, {'measure': 'Mean Change From Baseline in Ferritin at Week 16 and Week 24', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in ferritin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.'}, {'measure': 'Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in each parameter \\[iron, total iron binding capacity (TIBC), and creatinine\\] was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.'}, {'measure': 'Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in each parameter (transferrin and albumin) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.'}, {'measure': 'Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in transferrin saturation (TSAT) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.'}, {'measure': 'Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in C-reactive protein was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.'}, {'measure': 'Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in each parameter (phosphate and potassium) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.'}, {'measure': 'Mean Change From Baseline in Weight at Week 16 and Week 24', 'timeFrame': 'BL (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Mean change from BL in weight was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.'}, {'measure': 'Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24', 'timeFrame': 'Baseline (Week -4 to Week 0), Week 16, and Week 24', 'description': 'Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured before blood sampling and C.E.R.A. administration. Blood pressure was assessed both before and after the dialysis session for participants undergoing hemodialysis. Change from BL in blood pressure was calculated as the value at a specific week (W) during the study minus the BL value. The baseline was defined as Week -4 to Week 0.'}, {'measure': 'Number of Participants Taking Concomitant Medications', 'timeFrame': 'Up to Week 28', 'description': 'The number of participants taking different classes of concomitant medications at any time following enrollment into the study is presented.'}, {'measure': 'Number of Participants With Any Adverse Events and Serious Adverse Events', 'timeFrame': 'Up to Week 28', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be 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. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.'}, {'measure': 'Number of Participants With Reports of Anti-erythropoietin Antibodies', 'timeFrame': 'Up to Week 24', 'description': 'The number of participants with Anti-epoetin antibodies is presented.'}, {'measure': 'Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period', 'timeFrame': 'Week 1 to Week 24', 'description': 'Red blood cell transfusions were permitted during the DTP and EEP (Week 1 to Week 24) in case of medical need. All participants requiring a blood transfusion were withdrawn from the study. The number of participants who were administered RBC transfusions during the DTP and EEP is presented.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia']}, 'referencesModule': {'references': [{'pmid': '26965694', 'type': 'DERIVED', 'citation': 'Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>= 18 years of age;\n* chronic renal anemia;\n* continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;\n* regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.\n\nExclusion Criteria:\n\n* transfusion of red blood cells during previous 2 months;\n* poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months;\n* significant acute or chronic bleeding.'}, 'identificationModule': {'nctId': 'NCT00661505', 'briefTitle': 'A Study of Intravenous Mircera in Hemodialysis Patients 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 Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Haemodialysis Patients With Chronic Renal Anaemia.', 'orgStudyIdInfo': {'id': 'ML21096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C.E.R.A. 120, 200, or 360 mcg', 'description': 'Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\\<8000 IU, 8000-16000 IU, or \\>16000 IU) or darbepoetin alpha (\\<40 mcg, 40-80 mcg, or \\>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).', 'interventionNames': ['Drug: methoxy polyethylene glycol-epoetin beta']}], 'interventions': [{'name': 'methoxy polyethylene glycol-epoetin beta', 'type': 'DRUG', 'description': '120, 200 or 360 micrograms iv every 4 weeks (starting dose)', 'armGroupLabels': ['C.E.R.A. 120, 200, or 360 mcg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01330', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova University Medical Faculty; Internal Medicine', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Research and Training Hospital; The Clinic of Nephrology', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University School of Medicine; Nephrology', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Faith University School of Medicine; Nephrology', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University Medical Faculty; Department of Internal Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06490', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Baskent University Hospital; Transplantation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06500', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University School of Medicine; Nephrology', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '09100', 'city': 'Aydin', 'country': 'Turkey (Türkiye)', 'facility': 'Adnan Menderes Uni School of Medicine; Physical Therapy & Rehabilitation', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}, {'zip': '10000', 'city': 'Diyarbakır', 'country': 'Turkey (Türkiye)', 'facility': 'Dicle Uni Medical Faculty; Internal Medicine', 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}, {'zip': '22030', 'city': 'Edirne', 'country': 'Turkey (Türkiye)', 'facility': 'Trakya University Medical Faculty; Internal Medicine; Nephrology', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}, {'zip': '23110', 'city': 'Elâzığ', 'country': 'Turkey (Türkiye)', 'facility': 'Firat Uni School Of Medicine; Nephrology', 'geoPoint': {'lat': 38.67431, 'lon': 39.22321}}, {'zip': '25240', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk University Medical Faculty; Department of Internal Medicine', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}, {'zip': '34377', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sisli Etfal Research and Training Hospital; The Clinic of Nephrology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34390', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University Istanbul Medical Faculty; Department of Internal Medicine', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34662', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara Uni School of Medicine; Nephrology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35290', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir Ataturk Research and Training Hospital; The Clinic of Nephrology', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Dokuz Eylul University School of Medicine; Nephrology', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '38039', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University School of Medicine; Nephrology', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}, {'zip': '44300', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Inonu Uni School of Medicine', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}, {'zip': '33169', 'city': 'Mersin', 'country': 'Turkey (Türkiye)', 'facility': 'Mersin University Medical Faculty', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}