Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-01 @ 11:14 PM
Study NCT ID:
NCT04711603
Status:
COMPLETED
Last Update Posted:
2025-09-10
First Post:
2021-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rinsyousiken@pharm.kissei.co.jp', 'phone': 'Email olly', 'title': 'Clinical Development Division', 'organization': 'Kissei Pharmaceutical Co., Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 58 (6-week Double Blind Treatment Period and 52-week Extension Period)', 'description': 'Adverse Events were not collected separately for the Extension Period, but rather were pre-specified to be collected for the separate "MR-MR Group" and "P-MR Group" Arms/Groups separately for the Double Blind Period and for the entire study. Therefore, we have presented separate Arms/Groups for the Double-Blind Period (data monitored/assessed over 6 weeks), and the Entire Study Period (data monitored/assessed over 58 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Double Blind Period: MR13A9 0.5 μg/kg Group', 'description': "MR13A9 was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).\n\nThe dose of the study drug was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.\n\n1. \\<45.0 kg: 17.5 μg\n2. \\>=45.0 kg, \\<65.0 kg: 25.0 μg\n3. \\>=65.0 kg, \\<85.0 kg: 35.0 μg\n4. \\>=85.0 kg: 42.5 μg", 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 27, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Double Blind Period: Placebo Group', 'description': "Placebo was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).\n\nThe dose of the study drug was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.\n\n1. \\<45.0 kg: 0 μg\n2. \\>=45.0 kg, \\<65.0 kg: 0 μg\n3. \\>=65.0 kg, \\<85.0 kg: 0 μg\n4. \\>=85.0 kg: 0 μg", 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 24, 'seriousNumAtRisk': 89, 'deathsNumAffected': 1, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Entire Study: MR-MR Group', 'description': "\\[Double-blind period (6 weeks)\\] The subjects in this group received the investigational drug for 6 weeks as the MR13A9 0.5 μg/kg group.\n\n\\[Extension period (52 weeks)\\]\n\nThe study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 52 weeks (3 times weekly, 156 times in total).\n\nThe dose of the study drug was determined according to mentioned below, and the dose of the study drug from Week 6 to immediately before Week 34 will be determined based on the subject's dry weight before dialysis at Week 6. The dose of the study drug after Week 34 will be determined based on the subject's dry weight before dialysis at Week 34. The study drug (MR13A9) will not be administered at Week 58.\n\n1. \\<45.0 kg: 17.5 μg\n2. \\>=45.0 kg, \\<65.0 kg: 25.0 μg\n3. \\>=65.0 kg, \\<85.0 kg: 35.0 μg\n4. \\>=85.0 kg: 42.5 μg", 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 74, 'seriousNumAtRisk': 85, 'deathsNumAffected': 2, 'seriousNumAffected': 33}, {'id': 'EG003', 'title': 'Entire Study: P-MR Group', 'description': "\\[Double-blind period (6 weeks)\\] The subjects in this group received the investigational drug for 6 weeks as the Placebo group.\n\n\\[Extension period (52 weeks)\\]\n\nThe study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 52 weeks (3 times weekly, 156 times in total).\n\nThe dose of the study drug was determined according to mentioned below, and the dose of the study drug from Week 6 to immediately before Week 34 will be determined based on the subject's dry weight before dialysis at Week 6. The dose of the study drug after Week 34 will be determined based on the subject's dry weight before dialysis at Week 34. The study drug (MR13A9) will not be administered at Week 58.\n\n1. \\<45.0 kg: 17.5 μg\n2. \\>=45.0 kg, \\<65.0 kg: 25.0 μg\n3. \\>=65.0 kg, \\<85.0 kg: 35.0 μg\n4. \\>=85.0 kg: 42.5 μg", 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 74, 'seriousNumAtRisk': 83, 'deathsNumAffected': 2, 'seriousNumAffected': 38}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 26, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 16, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Vaccination site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 25, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 22, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Shunt stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 16, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 18, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Vaccination complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Dialysis hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}], 'seriousEvents': [{'term': 'Immune thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Nephrogenic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Large intestinal polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Mean NRS Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MR13A9 0.5 μg/kg Group', 'description': "The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).\n\nThe dose of the study drug (MR13A9) was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.\n\n1. \\<45.0 kg: 17.5 μg\n2. \\>=45.0 kg, \\<65.0 kg: 25.0 μg\n3. \\>=65.0 kg, \\<85.0 kg: 35.0 μg\n4. \\>=85.0 kg: 42.5 μg"}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.06', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Placebo difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.97', 'ciLowerLimit': '-1.52', 'ciUpperLimit': '-0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.28', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The change from baseline in the mean NRS score at each time point was calculated using an MMRM with the change from baseline in the mean NRS score at each time point as an objective variable, group, time point, and group-by-time point interaction as fixed effects, mean NRS score at baseline and presence or absence of prior treatment with nalfurafine hydrochloride as dynamic allocation factors as a covariate, and subjects as a random effect for data up to Week 4 of the double-blind period in FAS.\n\nLooking back on the period between the time of awakening on the previous day of assessment and the time of awakening on the day of assessment (including sleeping hours) once daily, subjects will assess the NRS score for the most severe itching by themselves. The most severe itching within the day will be assessed in integer on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Double Blind Period: MR13A9 0.5 μg/kg Group', 'description': "MR13A9 was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).\n\nThe dose of the study drug was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.\n\n1. \\<45.0 kg: 17.5 μg\n2. \\>=45.0 kg, \\<65.0 kg: 25.0 μg\n3. \\>=65.0 kg, \\<85.0 kg: 35.0 μg\n4. \\>=85.0 kg: 42.5 μg"}, {'id': 'FG001', 'title': 'Double Blind Period: Placebo Group', 'description': "Placebo was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).\n\nThe dose of the study drug was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.\n\n1. \\<45.0 kg: 0 μg\n2. \\>=45.0 kg, \\<65.0 kg: 0 μg\n3. \\>=65.0 kg, \\<85.0 kg: 0 μg\n4. \\>=85.0 kg: 0 μg"}, {'id': 'FG002', 'title': 'Entire Study: MR13A9/MR13A9 Group', 'description': "\\[Double-blind period (6 weeks)\\] The subjects in this group received the investigational drug for 6 weeks as the MR13A9 0.5 μg/kg group.\n\n\\[Extension period (52 weeks)\\] The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 52 weeks (3 times weekly, 156 times in total).\n\nThe dose of the study drug was determined according to mentioned below, and the dose of the study drug from Week 6 to immediately before Week 34 will be determined based on the subject's dry weight before dialysis at Week 6. The dose of the study drug after Week 34 will be determined based on the subject's dry weight before dialysis at Week 34. The study drug (MR13A9) will not be administered at Week 58.\n\n1. \\<45.0 kg: 17.5 μg\n2. \\>=45.0 kg, \\<65.0 kg: 25.0 μg\n3. \\>=65.0 kg, \\<85.0 kg: 35.0 μg\n4. \\>=85.0 kg: 42.5 μg"}, {'id': 'FG003', 'title': 'Entire Study: Placebo/MR13A9 Group', 'description': "\\[Double-blind period (6 weeks)\\] The subjects in this group received the investigational drug for 6 weeks as the Placebo group.\n\n\\[Extension period (52 weeks)\\] The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 52 weeks (3 times weekly, 156 times in total).\n\nThe dose of the study drug was determined according to mentioned below, and the dose of the study drug from Week 6 to immediately before Week 34 will be determined based on the subject's dry weight before dialysis at Week 6. The dose of the study drug after Week 34 will be determined based on the subject's dry weight before dialysis at Week 34. The study drug (MR13A9) will not be administered at Week 58.\n\n1. \\<45.0 kg: 17.5 μg\n2. \\>=45.0 kg, \\<65.0 kg: 25.0 μg\n3. \\>=65.0 kg, \\<85.0 kg: 35.0 μg\n4. \\>=85.0 kg: 42.5 μg"}], 'periods': [{'title': 'Double-blind Period (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': '4 consecutive missed doses of the study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Extension Period (52 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '85'}, {'groupId': 'FG003', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '68'}, {'groupId': 'FG003', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': '7 consecutive missed doses of the study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Needed to prioritize the treatment of adverse events', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Difficulty in using iPad for efficacy evaluation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'The input rate of the symptom diary was low and no improvement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Transferred to another hospital', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Two hundred thirty subjects were screened. A total of 178 subjects included in the study and were randomly assigned to the study drug. The number of subjects in the double-blind period (6 weeks) was 178. The number of subjects who transitioned to the extension period (52 weeks) was 168. The number of subjects who completed Week 58 was 122.', 'preAssignmentDetails': 'Previously treated hemodialysis patients with pruritus were enrolled in a 1:1 ratio to either MR13A9 0.5 μg/kg group or Placebo group. Subjects who received placebo in the double-blind period received MR13A9 0.5 μg/kg in the extension period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MR13A9 0.5 μg/kg Group', 'description': "The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).\n\nThe dose of the study drug (MR13A9) was determined according to mentioned below based on the subject's dry weight before dialysis on the start day of the screening period.\n\n1. \\<45.0 kg: 17.5 μg\n2. \\>=45.0 kg, \\<65.0 kg: 25.0 μg\n3. \\>=65.0 kg, \\<85.0 kg: 35.0 μg\n4. \\>=85.0 kg: 42.5 μg"}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'The study drug was injected into the venous line of the dialysis circuit at the end of each dialysis session for 6 weeks (3 times weekly, 18 times in total).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.4', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '64.1', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '64.2', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '57', 'upperLimit': '72'}, {'value': '67', 'groupId': 'BG001', 'lowerLimit': '58', 'upperLimit': '73'}, {'value': '66', 'groupId': 'BG002', 'lowerLimit': '57', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Dry Weight at the start of Screening', 'classes': [{'categories': [{'measurements': [{'value': '62.64', 'spread': '11.63', 'groupId': 'BG000'}, {'value': '63.33', 'spread': '12.94', 'groupId': 'BG001'}, {'value': '62.99', 'spread': '12.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemodialysis History', 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '7.9', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '8.1', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Disease Duration of Itch', 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '4.6', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '5.1', 'spread': '4.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average NRS Score', 'classes': [{'categories': [{'measurements': [{'value': '6.57', 'spread': '1.29', 'groupId': 'BG000'}, {'value': '6.40', 'spread': '1.28', 'groupId': 'BG001'}, {'value': '6.48', 'spread': '1.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Looking back on the period between the time of awakening on the previous day of assessment and the time of awakening on the day of assessment (including sleeping hours) once daily, subjects will assess the NRS score for the most severe itching by themselves. The most severe itching within the day will be assessed in integer on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.', 'unitOfMeasure': 'points', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-28', 'size': 907394, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-26T02:14', 'hasProtocol': True}, {'date': '2022-10-24', 'size': 485644, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-26T02:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2021-01-13', 'resultsFirstSubmitDate': '2025-06-09', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-21', 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Mean NRS Score at Week 4', 'timeFrame': '4 weeks', 'description': 'The change from baseline in the mean NRS score at each time point was calculated using an MMRM with the change from baseline in the mean NRS score at each time point as an objective variable, group, time point, and group-by-time point interaction as fixed effects, mean NRS score at baseline and presence or absence of prior treatment with nalfurafine hydrochloride as dynamic allocation factors as a covariate, and subjects as a random effect for data up to Week 4 of the double-blind period in FAS.\n\nLooking back on the period between the time of awakening on the previous day of assessment and the time of awakening on the day of assessment (including sleeping hours) once daily, subjects will assess the NRS score for the most severe itching by themselves. The most severe itching within the day will be assessed in integer on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uremic Pruritus']}, 'referencesModule': {'references': [{'pmid': '38320524', 'type': 'DERIVED', 'citation': 'Narita I, Tsubakihara Y, Takahashi N, Ebata T, Uchiyama T, Marumo M, Okamura S, Gejyo F; MR13A9-5 Trial Investigators. Difelikefalin for Hemodialysis Patients with Pruritus in Japan. NEJM Evid. 2023 Nov;2(11):EVIDoa2300094. doi: 10.1056/EVIDoa2300094. Epub 2023 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'Double-blind, Placebo-controlled study to confirm the superiority of MR13A9 to placebo, and followed by extension, open-label treatment to confirm long-term safety of MA13A9 in hemodialysis patients with pruritus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with Chronic Kidney Disease (CKD) has been on hemodialysis 3 times per week\n* Patient receiving treatment for itch\n* Patient has a baseline NRS score \\> 4\n\nExclusion Criteria:\n\n* Patient has pruritus cause other than CKD or its complications\n* Patients has hepatic cirrhosis\n* Patient has a known history of allergic reaction to opiates'}, 'identificationModule': {'nctId': 'NCT04711603', 'briefTitle': 'A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus', 'orgStudyIdInfo': {'id': 'MR13A9-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MR13A9/MR13A9', 'description': 'Patients are administered MR13A9 for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).', 'interventionNames': ['Drug: MR13A9']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/MR13A9', 'description': 'Patients are administered Placebo for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).', 'interventionNames': ['Drug: MR13A9', 'Drug: Placebo']}], 'interventions': [{'name': 'MR13A9', 'type': 'DRUG', 'description': 'Intravenous administration', 'armGroupLabels': ['MR13A9/MR13A9', 'Placebo/MR13A9']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intravenous administration', 'armGroupLabels': ['Placebo/MR13A9']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Research Site'}], 'overallOfficials': [{'name': 'Yoshitaka Shimizu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kissei Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}