Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-02-19 @ 4:27 AM
Study NCT ID:
NCT02707757
Status:
COMPLETED
Last Update Posted:
2021-04-14
First Post:
2016-02-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment Response in Dialysis Anaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077605', 'term': 'Ferric Oxide, Saccharated'}, {'id': 'C103998', 'term': 'epoetin beta'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005937', 'term': 'Glucaric Acid'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'd.ashby@imperial.ac.uk', 'title': 'Dr Damien Ashby', 'organization': 'Imperial Healthcare NHS Trust'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Iron Sucrose', 'description': "Iron sucrose 200mg for 5 doses\n\nIron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl", 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 2, 'seriousNumAtRisk': 88, 'deathsNumAffected': 3, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Neorecormon', 'description': 'Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000\n\nErythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 1, 'seriousNumAtRisk': 96, 'deathsNumAffected': 2, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Cervical discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Psoas abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Iron Sucrose', 'description': "Iron sucrose 200mg for 5 doses\n\nIron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl"}, {'id': 'OG001', 'title': 'Neorecormon', 'description': 'Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000\n\nErythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Iron Sucrose', 'description': "Iron sucrose 200mg for 5 doses\n\nIron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl"}, {'id': 'FG001', 'title': 'Neorecormon', 'description': 'Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000\n\nErythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'This refers to the number of times to which a participant was allocated to each respective treatment.\n\nA participant could be re-randomised 6 months following initial randomisation. Not all participants were randomised due to not meeting randomisation criteria.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Renal transplant/elective operation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': '197 prevalent haemodialysis patients', 'preAssignmentDetails': 'Recruitment from the study was the prevalent haemodialysis population. Those whom were recruited (197) were then followed until the monthly Hb, taken within routine haemodialysis care, triggered a randomisation event.\n\nExclusion criteria for either recruitment or a randomisation event:\n\nOvert blood loss Haematological or other malignancy'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Iron Sucrose', 'description': "Iron sucrose 200mg for 5 doses\n\nIron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl"}, {'id': 'BG001', 'title': 'Neorecormon', 'description': 'Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000\n\nErythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria'}, {'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': '37', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.22', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '86'}, {'value': '63.10', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '91'}, {'value': '63.16', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '91'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analysed on a per protocol rather than intention to treat basis'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-19', 'studyFirstSubmitDate': '2016-02-23', 'resultsFirstSubmitDate': '2021-01-26', 'studyFirstSubmitQcDate': '2016-03-08', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-16', 'studyFirstPostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Haemodialysis', 'Anaemia', 'Iron', 'Erythropoeitin stimulating agents'], 'conditions': ['Anaemia', 'Haemodialysis']}, 'descriptionModule': {'briefSummary': "Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two current possible treatments for anaemia which are iron and erythropoietin stimulating agents (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and haemoglobin, but these markers are known to be inaccurate. The current clinical protocol therefore tends towards overuse of both agents which can be associated with toxicity, and the reliance on these markers prevents retrospective assessment of treatment responsiveness. This study is designed to investigate the factors which predict which agent would produce a better response. Patients with a fall in haemoglobin will be given treatment with either iron or an increased dose of ESA as they are currently, but allocated at random rather than by poorly performing biochemical markers. The iron treated and ESA treated groups can then be analysed for factors which predict response in o"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All prevalent haemodialysis patients of the Imperial Renal and Transplant Centre will be eligible for inclusion if they have been on dialysis for more than 3 months\n\nExclusion Criteria:\n\n* Patients with a bone marrow disorder, active infection or active malignancy will be excluded as these are non-renal causes of anaemia. Patients unable to give informed consent will also not be included within the study.'}, 'identificationModule': {'nctId': 'NCT02707757', 'acronym': 'PRIME', 'briefTitle': 'Treatment Response in Dialysis Anaemia', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College Healthcare NHS Trust'}, 'officialTitle': 'Predictors of Response to Treatment With Iron and Erythropoietin in Dialysis Anaemia', 'orgStudyIdInfo': {'id': '14HH1987'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Iron sucrose', 'description': 'Iron sucrose 200mg for 5 doses', 'interventionNames': ['Drug: Iron sucrose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neorecormon', 'description': 'Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000', 'interventionNames': ['Drug: Erythopoietin stimulating agent']}], 'interventions': [{'name': 'Iron sucrose', 'type': 'DRUG', 'otherNames': ['Venofer'], 'description': "1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl", 'armGroupLabels': ['Iron sucrose']}, {'name': 'Erythopoietin stimulating agent', 'type': 'DRUG', 'otherNames': ['Neorecormon'], 'description': 'Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria', 'armGroupLabels': ['Neorecormon']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial Renal and Transplant Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial NHS Healthcare Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Damien Dr Ashby, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College Healthcare NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College Healthcare NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}