Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-01-01 @ 3:39 PM
Study NCT ID:
NCT00717366
Status:
COMPLETED
Last Update Posted:
2017-09-08
First Post:
2008-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C508420', 'term': 'continuous erythropoietin receptor activator'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Week 73', 'description': 'Safety population included all participants who received at least one dose of study drug and had a safety follow-up visit.', 'eventGroups': [{'id': 'EG000', 'title': 'MIRCERA Group 1: Intermediate-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/250 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.', 'otherNumAtRisk': 16, 'otherNumAffected': 11, 'seriousNumAtRisk': 16, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'MIRCERA Group 2: High-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/125 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.', 'otherNumAtRisk': 48, 'otherNumAffected': 28, 'seriousNumAtRisk': 48, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Catheter site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'H1N1 influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperparathyroidism secondary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Staphylococcal scalded skin syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arteriovenous fistula thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arterial injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Transplant failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thrombosis in device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intracranial haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lupus nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Average Hb Concentration Between Baseline and Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRCERA Group 1: Intermediate-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/250 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}, {'id': 'OG001', 'title': 'MIRCERA Group 2: High-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/125 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}], 'classes': [{'title': 'Baseline (n=16,48)', 'categories': [{'measurements': [{'value': '11.26', 'spread': '0.496', 'groupId': 'OG000'}, {'value': '11.08', 'spread': '0.493', 'groupId': 'OG001'}]}]}, {'title': 'Change at Evaluation Period (n=12,36)', 'categories': [{'measurements': [{'value': '-0.78', 'spread': '1.237', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '1.014', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)', 'description': 'A time adjusted average baseline Hb concentration for each individual was calculated using an area under the curve (AUC) approach from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Week 17 to Week 21). The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb concentration from the evaluation period Hb concentration.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRCERA Group 1: Intermediate-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/250 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}, {'id': 'OG001', 'title': 'MIRCERA Group 2: High-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/125 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Evaluation Period (Week 17 to Week 21)', 'description': 'Baseline Hb value was defined as the average Hb concentration from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number of participants analyzed = participants with Hb concentration assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRCERA Group 1: Intermediate-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/250 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}, {'id': 'OG001', 'title': 'MIRCERA Group 2: High-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/125 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}], 'classes': [{'title': 'Above 12 g/dL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Within 10-12 g/dL', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Below 10 g/dL', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Evaluation Period (Week 17 to Week 21)', 'description': 'The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number of participants analyzed = participants with Hb concentration assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Blood Transfusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRCERA Group 1: Intermediate-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/250 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}, {'id': 'OG001', 'title': 'MIRCERA Group 2: High-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/125 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 20', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Change in Average Reticulocyte Count Between the Baseline and Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRCERA Group 1: Intermediate-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/250 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}, {'id': 'OG001', 'title': 'MIRCERA Group 2: High-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/125 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}], 'classes': [{'title': 'Baseline (n=15,48)', 'categories': [{'measurements': [{'value': '46.08', 'spread': '26.472', 'groupId': 'OG000'}, {'value': '43.70', 'spread': '25.984', 'groupId': 'OG001'}]}]}, {'title': 'Change at Evaluation Period (n=11,36)', 'categories': [{'measurements': [{'value': '23.38', 'spread': '29.279', 'groupId': 'OG000'}, {'value': '24.80', 'spread': '32.428', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)', 'description': 'A time adjusted average baseline reticulocyte count for each individual was calculated using an AUC approach from all available reticulocyte counts taken during the baseline period (Day -20 to Day 1). The average evaluation period reticulocyte count for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Weeks 17 to 21). The change in reticulocyte count between the baseline and evaluation periods was calculated by subtracting the baseline reticulocyte count from the evaluation period reticulocyte count. Relative reticulocytes were recorded conversion to absolute values was performed.', 'unitOfMeasure': '10^3 cells/microliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Reticulocyte values within 21 days after blood transfusion(s) were excluded from analysis. Here, number of participants analyzed = participants evaluable for this outcome measure and 'n' signifies number of participants evaluable at specified time-points."}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) of MIRCERA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRCERA Group 1: Intermediate-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/250 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}, {'id': 'OG001', 'title': 'MIRCERA Group 2: High-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/125 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '37700', 'spread': '74.5', 'groupId': 'OG000'}, {'value': '66100', 'spread': '149.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13', 'description': 'Cmax was defined as the highest serum concentration observed from all sample collection timepoints (as provided in timeframe) and was averaged out among participants and reported.', 'unitOfMeasure': 'picograms per milliliter (pg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic (PK) evaluable population included all enrolled participants who received at least one dose of study drug and had evaluable PK assessment. Here 'n' signifies number of participants evaluable at specified time-points."}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRCERA Group 1: Intermediate-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/250 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}, {'id': 'OG001', 'title': 'MIRCERA Group 2: High-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/125 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3630000', 'spread': '91.8', 'groupId': 'OG000'}, {'value': '7170000', 'spread': '140.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13', 'description': 'Area under the serum concentration versus time curve over 672 hours. AUC0-672h represents area under the serum concentration versus time curve from time zero to end of dosing interval (AUC0-tau).', 'unitOfMeasure': 'picograms*hour/milliliter (pg*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population. Number of participants analyzed = participants with AUC0-672h assessment at specified time-points.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Cmax (Tmax) of MIRCERA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRCERA Group 1: Intermediate-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/250 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}, {'id': 'OG001', 'title': 'MIRCERA Group 2: High-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/125 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.98', 'upperLimit': '2.17'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.83', 'upperLimit': '164'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13', 'description': 'Tmax was defined as the time (in hours) to achieve Cmax (Cmax was defined as the highest serum concentration observed over all sample collection timepoints \\[as provided in timeframe\\]). The median time, among all participants, was reported.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population.'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Phase Half-Life (t1/2) of MIRCERA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRCERA Group 1: Intermediate-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/250 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}, {'id': 'OG001', 'title': 'MIRCERA Group 2: High-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/125 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '147', 'spread': '30.1', 'groupId': 'OG000'}, {'value': '121', 'spread': '43.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13', 'description': 't1/2 was defined as the time (in hours) measured (from all sample collection timepoints \\[as provided in timeframe\\]) for the serum concentration to decrease by one half. The t1/2 was calculated as natural logarithm of 2 divided by λz; where λz = terminal elimination rate constant.', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population. Number of participants analyzed = participants evaluable for t1/2 assessments.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MIRCERA Group 1: Intermediate-Conversion-Factor Group', 'description': 'Participants received methoxy polyethylene glycol-epoetin beta (MIRCERA) intravenous (IV) injection at a starting dose based on an intermediate conversion factor from their previous Erythropoiesis-Stimulating Agent (ESA) dose (4 \\* previous weekly epoetin dose \\[international units {IU}\\]/250 or 4 \\* previous weekly darbepoetin alfa dose \\[micrograms {mcg}\\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had hemoglobin (Hb) level within ± 1 grams per deciliter (g/dL) of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}, {'id': 'FG001', 'title': 'MIRCERA Group 2: High-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/125 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}], 'periods': [{'title': 'Core Study Period (20 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Renal transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Admin/Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Refused treatment/Did not cooperate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Extension Period (52 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Received Visit/Week 21 Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Renal transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Admin/Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 112 participants were screened at 28 sites in 10 countries, of which 64 participants were enrolled (16 initially in MIRCERA Group 1 and then 48 in MIRCERA Group 2, following a preliminary analysis of MIRCERA Group 1).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MIRCERA Group 1: Intermediate-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection at a starting dose based on an intermediate conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/250 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/1.1) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}, {'id': 'BG001', 'title': 'MIRCERA Group 2: High-Conversion-Factor Group', 'description': 'Participants received MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/125 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/0.55) once every 4 weeks for 20 weeks. Participants who completed the 20 weeks of treatment and had Hb level within ± 1 g/dL of their baseline Hb level and within the target range of 10-12 g/dL, entered an optional 52-weeks safety extension period. During this period, the participants continued to receive MIRCERA IV injection once every 4 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'spread': '3.24', 'groupId': 'BG000'}, {'value': '13.0', 'spread': '3.06', 'groupId': 'BG001'}, {'value': '12.6', 'spread': '3.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intention-to-treat (ITT) population included all enrolled participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2008-07-16', 'resultsFirstSubmitDate': '2016-09-29', 'studyFirstSubmitQcDate': '2008-07-16', 'lastUpdatePostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-08', 'studyFirstPostDateStruct': {'date': '2008-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Average Hb Concentration Between Baseline and Evaluation Period', 'timeFrame': 'Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)', 'description': 'A time adjusted average baseline Hb concentration for each individual was calculated using an area under the curve (AUC) approach from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Week 17 to Week 21). The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb concentration from the evaluation period Hb concentration.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb', 'timeFrame': 'Evaluation Period (Week 17 to Week 21)', 'description': 'Baseline Hb value was defined as the average Hb concentration from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).'}, {'measure': 'Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL', 'timeFrame': 'Evaluation Period (Week 17 to Week 21)', 'description': 'The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).'}, {'measure': 'Number of Participants With Blood Transfusions', 'timeFrame': 'Baseline to Week 20'}, {'measure': 'Change in Average Reticulocyte Count Between the Baseline and Evaluation Period', 'timeFrame': 'Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)', 'description': 'A time adjusted average baseline reticulocyte count for each individual was calculated using an AUC approach from all available reticulocyte counts taken during the baseline period (Day -20 to Day 1). The average evaluation period reticulocyte count for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Weeks 17 to 21). The change in reticulocyte count between the baseline and evaluation periods was calculated by subtracting the baseline reticulocyte count from the evaluation period reticulocyte count. Relative reticulocytes were recorded conversion to absolute values was performed.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of MIRCERA', 'timeFrame': 'Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13', 'description': 'Cmax was defined as the highest serum concentration observed from all sample collection timepoints (as provided in timeframe) and was averaged out among participants and reported.'}, {'measure': 'Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA', 'timeFrame': 'Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13', 'description': 'Area under the serum concentration versus time curve over 672 hours. AUC0-672h represents area under the serum concentration versus time curve from time zero to end of dosing interval (AUC0-tau).'}, {'measure': 'Time to Reach Cmax (Tmax) of MIRCERA', 'timeFrame': 'Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13', 'description': 'Tmax was defined as the time (in hours) to achieve Cmax (Cmax was defined as the highest serum concentration observed over all sample collection timepoints \\[as provided in timeframe\\]). The median time, among all participants, was reported.'}, {'measure': 'Apparent Terminal Phase Half-Life (t1/2) of MIRCERA', 'timeFrame': 'Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13', 'description': 't1/2 was defined as the time (in hours) measured (from all sample collection timepoints \\[as provided in timeframe\\]) for the serum concentration to decrease by one half. The t1/2 was calculated as natural logarithm of 2 divided by λz; where λz = terminal elimination rate constant.'}]}, 'conditionsModule': {'conditions': ['Renal Anemia']}, 'descriptionModule': {'briefSummary': 'This sequential study will assess the efficacy and safety of multiple doses of intravenous (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum starting dose for maintenance treatment of anemia in children with chronic kidney disease on hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they will receive IV MIRCERA monthly, at a starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on the response achieved, another group may be selected to receive a higher or a lower dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 5-17 years (in Russia only: 12-17 years) with clinically stable chronic renal anemia\n* Hemodialysis for greater than or equal to (\\>=) 8 weeks\n* Intravenous stable maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa for \\>= 8 weeks before screening and with no weekly dose change \\>= 25 percent (%) (increase or decrease) during the 2 weeks of screening\n\nExclusion Criteria:\n\n* Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period\n* Red blood cell (RBC) transfusions within 8 weeks before screening or during the screening period\n* Active malignant disease\n* Pure red cell aplasia (PRCA) or history of PRCA\n* Pregnant or lactating females\n* Sexually active participants: not willing to use reliable contraception during treatment and for 90 days following the end of treatment'}, 'identificationModule': {'nctId': 'NCT00717366', 'briefTitle': 'Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open-Label Multi-center, Multiple Dose Study to Determine the Optimum Starting Dose of Intravenous MIRCERA for Maintenance Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease on Hemodialysis', 'orgStudyIdInfo': {'id': 'NH19707'}, 'secondaryIdInfos': [{'id': '2007-007758-70', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MIRCERA Group 1: Intermediate-Conversion-Factor Group', 'description': 'Participants will receive methoxy polyethylene glycol-epoetin beta (MIRCERA) IV injection at a starting dose based on an intermediate conversion factor from their previous Erythropoiesis-stimulating Agent (ESA) dose (4 \\* previous weekly epoetin dose \\[international units {IU}\\]/250 or 4 \\* previous weekly darbepoetin alfa dose \\[micrograms {mcg}\\]/1.1) once every 4 weeks for 20 weeks. Participants who will complete the 20 weeks of treatment with hemoglobin (Hb) level within ± 1 grams per deciliter (g/dL) of their baseline Hb level and within the target range of 10-12 g/dL will enter an optional 52-weeks safety extension period. During this period, the participants will continue to receive MIRCERA IV injection once every 4 weeks.', 'interventionNames': ['Drug: Methoxy Polyethylene Glycol-Epoetin Beta']}, {'type': 'EXPERIMENTAL', 'label': 'MIRCERA Group 2: High-Conversion-Factor Group', 'description': 'Participants will receive MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \\* previous weekly epoetin dose \\[IU\\]/125 or 4 \\* previous weekly darbepoetin alfa dose \\[mcg\\]/0.55) once every 4 weeks for 20 weeks. Participants who will complete the 20 weeks of treatment with Hb within ± 1 g/dL of their baseline Hb and within the target range of 10-12 g/dL will enter an optional 52-weeks safety extension period. During this period, the participants will continue to receive MIRCERA IV injection once every 4 weeks.', 'interventionNames': ['Drug: Methoxy Polyethylene Glycol-Epoetin Beta']}], 'interventions': [{'name': 'Methoxy Polyethylene Glycol-Epoetin Beta', 'type': 'DRUG', 'otherNames': ['MIRCERA', 'RO0503821'], 'description': 'Will be administered IV, every 4 weeks.', 'armGroupLabels': ['MIRCERA Group 1: Intermediate-Conversion-Factor Group', 'MIRCERA Group 2: High-Conversion-Factor Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': "Royal Children'S Hospital; Department of Nephrology", 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hôpital Enfants Reine Fabiola', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hopital Jeanne De Flandre; Cons Pediatrie', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Timone Enfants; Nephrologie Hemodialyse', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hopital Arnaud De Villeneuve; Pediatrie I', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Robert Debré; Nephrologie pediatrique', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Armand Trousseau; Pediatrie Nephrologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Höpital Hautepierre; Pediatrie 1', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Klinik der Uni zu Köln; Kinderklinik', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'KfH Nierenzentrum für Kinder und Jugendliche', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum fur Kinder und Jugendliche', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '87700', 'city': 'Memmingen', 'country': 'Germany', 'facility': 'Kinderklinik Memmingen; Kinderdialysezentrum', 'geoPoint': {'lat': 47.98372, 'lon': 10.18527}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum für Kinder und Jugendliche', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '00165', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Ospedale Pediatrico Bambino Gesu; U.O. Di Nefrologia E Dialisi', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '16148', 'city': 'Genoa', 'state': 'Liguria', 'country': 'Italy', 'facility': 'IRCCS G. Gaslini; U.O. Nefrologia, Dialisi e Trapianto', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '10126', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '35128', 'city': 'Padua', 'state': 'Veneto', 'country': 'Italy', 'facility': 'A.O. Di Padova; Dipartimento Di Pediatria U.O. Di Nefrologia Pediatrica, Dialisi e Trapianto', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '80-294', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '93-338', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Instytut "Centrum Zdrowia Matki Polki; Klinika Nefrologii i Dializoterapii', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-093', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Dzieciecy Szpital Kliniczny; Klinika Nefrologii Dzieciecej', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '70-410', 'city': 'Szczecin', 'country': 'Poland', 'facility': 'SPSZOZ Zdroje Oddzial Pediatrii; Nefrologii i Toksykologii ze Stacja Dializ', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '87-100', 'city': 'Torun', 'country': 'Poland', 'facility': 'Wojewodzki Szpital Dzieciecy; Osrodek Chorob Nerek i Dializoterapii', 'geoPoint': {'lat': 53.01375, 'lon': 18.59814}}, {'zip': '04-730', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-369', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Akademia Medyczna im. Piastow Slaskich; Katedra i Klinika Nefrologii Pediatrycznej', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '022328', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Fundeni Clinical Institute', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '700309', 'city': 'Iași', 'country': 'Romania', 'facility': 'St. Maria Emergency Clinical Hospital for Children', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '107014', 'city': 'Moscow', 'country': 'Russia', 'facility': 'DGCB St. Vladimir; Pediatric nephrologist', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '198205', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'SBIH Children City Hospital #1; Dialysis department', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron; Servicio de Nefrologia", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz: Nefrologia Pediatrica', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario la Fe; Servicio de Nefrologia Pediatrica', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '10310', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn university Faculty of Medicine;Department of Pediatrics', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital, Faculty of Medicine; Department of Pediatrics', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '04209', 'city': 'Kiev', 'country': 'Ukraine', 'facility': 'Kiev city childrens nephrological center of hospital #1; Nephrology and RRT', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '69076', 'city': 'Zaporizhzhia', 'country': 'Ukraine', 'facility': "Public Institution Zaporizhzhia City Multispecialty Children's Hospital #5; Allergologic", 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}