Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT04829916
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2021-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
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'trials@guardtherapeutics.com', 'phone': '+46733319438', 'title': 'Head of Clinical Operations', 'organization': 'Guard Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Full study period, ie baseline through day 30.', 'eventGroups': [{'id': 'EG000', 'title': 'RMC-035', 'description': 'Participants received RMC-035 intravenously\n\nRMC-035: Multiple dosing during 48 hours following cardiac surgery', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received matching placebo solution intravenously\n\nPlacebo: Multiple dosing during 48 hours following cardiac surgery', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Small intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anaphylactoid reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'Participants received RMC-035 intravenously\n\nRMC-035: Multiple dosing during 48 hours following cardiac surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo solution intravenously\n\nPlacebo: Multiple dosing during 48 hours following cardiac surgery'}], 'classes': [{'title': 'Subject with at least one AE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Subject with at least one SAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with at least one TEAE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with at least one non-serious TEAE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with at least one serious TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with at least one TEAE of special interest', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with at least one TEAE reported as related (possible/probable)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with at least one TEAE leading to withdrawal of IMP', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through day 30', 'description': '* number (%) of subjects with at least one AE\n* number (%) of subjects with at least one SAE\n* number (%) of subjects with at least one Treatment-Emergent AE (TEAE)\n* number (%) of subjects with at least one serious TEAE\n* number (%) of subjects with at least one non-serious TEAE\n* number (%) of subjects with at least one TEAE of special interest\n* number (%) of subjects with at least one TEAEs reported as related (possible/probable) to IMP\n* number (%) of subjects with at least one TEAEs leading to withdrawal of IMP', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject who received any dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Severity of AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'Participants will receive RMC-035 intravenously\n\nRMC-035: Multiple dosing during 48 hours following cardiac surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive matching placebo solution intravenously\n\nPlacebo: Multiple dosing during 48 hours following cardiac surgery'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Life-threatening', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days from first dose of IMP', 'description': '\\- Number of TEAEs per category (mild, moderate, severe life-threatening, death)', 'unitOfMeasure': 'TEAEs', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of TEAEs occurring in 5 subjects on RMC-035 (N=8) and the # of TEAEs occurring in 1 subjects on placebo (N=4)'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'Participants received RMC-035 intravenously\n\nRMC-035: Multiple dosing during 48 hours following cardiac surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo solution intravenously\n\nPlacebo: Multiple dosing during 48 hours following cardiac surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '4.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples taken from pre-dose and up to two hours after start of Dose 5', 'description': 'Analysis of RMC-035 concentration in plasma (AUC + t1/2) after fourth infusion.', 'unitOfMeasure': 'mikrogram / milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects receiving any study drug.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC) 0-24h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'Participants received RMC-035 intravenously\n\nRMC-035: Multiple dosing during 48 hours following cardiac surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo solution intravenously\n\nPlacebo: Multiple dosing during 48 hours following cardiac surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'spread': '37.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples taken from pre-dose and up to two hours after start of Dose 5', 'description': 'Analysis of RMC-035 concentrations in plasma following the fourth infusion.', 'unitOfMeasure': 'hours * microgram / milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects receiving RMC-035'}, {'type': 'SECONDARY', 'title': 'Elimination Half-life (T1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'Participants received RMC-035 intravenously\n\nRMC-035: Multiple dosing during 48 hours following cardiac surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received matching placebo solution intravenously\n\nPlacebo: Multiple dosing during 48 hours following cardiac surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples taken from pre-dose and up to two hours after start of Dose 5', 'description': 'Analysis of RMC-035 concentration in plasma following the fourth infusion', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects receiving any RMC-035'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RMC-035', 'description': 'Participants received RMC-035 intravenously\n\nRMC-035: Multiple dosing during 48 hours following cardiac surgery'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received matching placebo solution intravenously\n\nPlacebo: Multiple dosing during 48 hours following cardiac surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In this study, 13 subjects were enrolled, ie agreed to participate in the study following completion of the informed consent process. However, 1 subject did not fulfill all eligibility criteria and was not randomization. Hence, 12 subjects started the study, ie were assigned to one of the treatment arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RMC-035', 'description': 'Participants received RMC-035 intravenously\n\nRMC-035: Multiple dosing during 48 hours following cardiac surgery'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received matching placebo solution intravenously\n\nPlacebo: Multiple dosing during 48 hours following cardiac surgery'}, {'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': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74.6', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '70.4', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '73.3', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', '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': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', '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': 'Germany', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '89.75', 'spread': '14.84', 'groupId': 'BG000'}, {'value': '78.75', 'spread': '2.99', 'groupId': 'BG001'}, {'value': '86.08', 'spread': '13.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29.04', 'spread': '3.42', 'groupId': 'BG000'}, {'value': '24.99', 'spread': '0.71', 'groupId': 'BG001'}, {'value': '27.69', 'spread': '3.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'eGFR', 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'spread': '16.5', 'groupId': 'BG000'}, {'value': '76.0', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '60.4', 'spread': '17.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-22', 'size': 850104, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-18T08:22', 'hasProtocol': True}, {'date': '2021-06-11', 'size': 1331123, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-18T08:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2021-03-26', 'resultsFirstSubmitDate': '2022-02-15', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-24', 'studyFirstPostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Adverse Events (AEs)', 'timeFrame': 'Baseline through day 30', 'description': '* number (%) of subjects with at least one AE\n* number (%) of subjects with at least one SAE\n* number (%) of subjects with at least one Treatment-Emergent AE (TEAE)\n* number (%) of subjects with at least one serious TEAE\n* number (%) of subjects with at least one non-serious TEAE\n* number (%) of subjects with at least one TEAE of special interest\n* number (%) of subjects with at least one TEAEs reported as related (possible/probable) to IMP\n* number (%) of subjects with at least one TEAEs leading to withdrawal of IMP'}, {'measure': 'Severity of AEs', 'timeFrame': 'Within 4 days from first dose of IMP', 'description': '\\- Number of TEAEs per category (mild, moderate, severe life-threatening, death)'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax)', 'timeFrame': 'Blood samples taken from pre-dose and up to two hours after start of Dose 5', 'description': 'Analysis of RMC-035 concentration in plasma (AUC + t1/2) after fourth infusion.'}, {'measure': 'Area Under the Curve (AUC) 0-24h', 'timeFrame': 'Blood samples taken from pre-dose and up to two hours after start of Dose 5', 'description': 'Analysis of RMC-035 concentrations in plasma following the fourth infusion.'}, {'measure': 'Elimination Half-life (T1/2)', 'timeFrame': 'Blood samples taken from pre-dose and up to two hours after start of Dose 5', 'description': 'Analysis of RMC-035 concentration in plasma following the fourth infusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AKI'], 'conditions': ['Acute Kidney Injury (AKI)']}, 'descriptionModule': {'briefSummary': 'The purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of RMC-035 for the prevention and treatment of acute kidney injury (AKI) in patients undergoing cardiac surgery.', 'detailedDescription': 'This is a study with two parallel treatment groups where subjects are randomized to receive RMC-035 or a matching placebo in a double-blind fashion. The study will comprise of a screening visit, followed by CABG and/or valve replacement on Day 1, double-blind treatment period and a follow-up period up to Day 30.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Female and male subjects with an age ≥18 years\n* Subject is scheduled for non-emergent (elective) CABG and/or valve surgery (single or multiple valves) with use of cardiopulmonary bypass (CPB)\n* Subject has at least ONE of the following risk factors for AKI at screening:\n\n * History of LVEF \\<35% for at least 3 months prior to screening assessed by either echocardiography, cardiac MRI or nuclear scan.\n * History of previous open chest cavity cardiac surgery with or without CPB\n * Confirmed diagnosis of type 2 diabetes (T2DM) at least 3 months prior to screening AND ongoing treatment with an approved anti-diabetic drug\n * Age ≥70 years\n * Documented history of heart failure NYHA class II or higher for at least 3 months or longer at screening\n * Documented history of previous AKI before date of screening independent of the etiology of AKI\n * Documented history of anemia with hemoglobin ≤ 11 g/dL (≤6.8 mmol/L) for at least 3 months prior to screening\n * Documented history of albuminuria, defined as UACR \\>30 mg/g or \\> 30 mg/24 hour in a 24-hour urine collection.\n * eGFR is ≤ 60 mL/min/1.73 m2 using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation\n\nKey Exclusion Criteria:\n\n* Estimated glomerular filtration rate (eGFR) is \\<30 mL/min/1.73 m2 using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation at screening or at baseline\n* Subject has surgery scheduled to be performed without CPB ("off-pump")\n* Subject has surgery scheduled for aortic dissection\n* Subject is scheduled for CABG and/or valve surgery combined with additional non-emergent cardiac surgeries, e.g. for atrial fibrillation ablation\n* Subject is scheduled to undergo trans catheter aortic valve implantation (TAVI) or trans catheter aortic valve replacement (TAVR), or single vessel off-pump surgeries or left ventricular device (LVAD) implantation\n* Subject has a requirement for any of the following within one week prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, other forms of mechanical circulatory support (MCS) (Note: The prophylactic insertion of an IABP preoperatively for reasons not related to existing LV pump function is not exclusionary)'}, 'identificationModule': {'nctId': 'NCT04829916', 'briefTitle': 'A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guard Therapeutics AB'}, 'officialTitle': 'A Phase 1b, Randomised, Double-Blind, Parallel Treatment Group Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RMC-035 in Subjects Undergoing Non-Emergent On-Pump Coronary Artery Bypass Graft and/or Valve Surgery', 'orgStudyIdInfo': {'id': '20-ROS-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RMC-035', 'description': 'Participants will receive RMC-035 intravenously', 'interventionNames': ['Drug: RMC-035']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive matching placebo solution intravenously', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RMC-035', 'type': 'DRUG', 'otherNames': ['Solution for injection'], 'description': 'Multiple dosing during 48 hours following cardiac surgery', 'armGroupLabels': ['RMC-035']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Solution for injection'], 'description': 'Multiple dosing during 48 hours following cardiac surgery', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DE-481 49', 'city': 'Münster', 'country': 'Germany', 'facility': 'Münster University Hospital', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Tobias Agervald, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guard Therapeutics AB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guard Therapeutics AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}