Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-02 @ 1:58 PM
Study NCT ID:
NCT05126303
Status:
TERMINATED
Last Update Posted:
2024-05-16
First Post:
2021-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sara.thuresson@guardtherapeutics.com', 'phone': '+46733319438', 'title': 'Sara Thuresson, Head of Clinical Operations', 'organization': 'Guard Therapeutics'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study was stopped prematurely for futility following Data Monitoring Committee (DMC) recommendation.\n\nThe early termination lead to smaller numbers than planned, and that not all outcome measures were analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'TEAEs (Treatment Emergent Adverse Events): 72 hours after last administration of study intervention, up to 90 days in total.', 'description': 'For non-serious Adverse Events, TEAEs are presented, ie any AE that occurred after the initial IMP administration through 72 hours (inclusive) after the final IMP administration.\n\nFor SAEs, all are presented as per standard definition.', 'eventGroups': [{'id': 'EG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 75, 'seriousNumAtRisk': 89, 'deathsNumAffected': 1, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 64, 'seriousNumAtRisk': 88, 'deathsNumAffected': 2, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 25}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypervolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Embolic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bronchial obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Venous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Blood fibrinogen decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Haemorrhagic diathesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypofibrinogenaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Low cardiac output syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Developing AKI, as Defined Per Kidney Disease Improving Global Outcomes (KDIGO) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '50.6', 'groupId': 'OG000'}, {'value': '39.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': 'Percentage of subjects developing AKI based on Serum Creatinine and/or Urine Output per KDIGO definition', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All dosed'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC) of Serum Creatinine (SCr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '1.17'}, {'value': '0.99', 'groupId': 'OG001', 'lowerLimit': '0.96', 'upperLimit': '1.02'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '72 hours', 'description': 'Time-corrected area under the curve (AUC) of serum creatinine calculated as follows:\n\nThe area under the SCr concentration versus time curve following drug administration were calculated using timepoints at Day 1 (12 hour), Day 2 (24 hour), Day 3 (48 hour) and Day 4 (72 hour). The individual log-transformed SCr values were determined, and the AUC (utilizing planned times) were calculated using the right Riemann sum: AUC = 0.5 x SCr(12h) + 0.5 x SCr(24h) + 1 x SCr(48h) + 1 x SCr(72h) The time-corrected AUC (log-scale) was then calculated as AUC/3', 'unitOfMeasure': 'log(mg/dL)/day', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Duration of AKI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '3.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Duration of AKI defined as the number of days meeting the definition of AKI (KDIGO definition) starting within 72 hours after first dose of IMP until resolution', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Change in SCr Values Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'title': '12 hours', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.11'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.05', 'upperLimit': '0.02'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.15'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '0.05'}]}]}, {'title': '48 hours', 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.13'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '0.05'}]}]}, {'title': '72 hours', 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.09'}, {'value': '-0.03', 'groupId': 'OG001', 'lowerLimit': '-0.07', 'upperLimit': '0.01'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '-0.00', 'upperLimit': '0.09'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-0.06', 'upperLimit': '0.02'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '-0.00', 'groupId': 'OG000', 'lowerLimit': '-0.04', 'upperLimit': '0.04'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '-0.02', 'upperLimit': '0.05'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.02'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '-0.01', 'upperLimit': '0.07'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'SCr at 12, 24, 48, and 72 hours, respectively, and at Day 7/discharge, Day 30 and Day 90', 'unitOfMeasure': 'mg/dL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Peak Cystatin C Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.26'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '0.16'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Change from baseline of peak cystatin C from baseline to Day 7', 'unitOfMeasure': 'mg/L', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'AUC of Cystatin C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '1.21', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '1.31', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '72 hours', 'description': 'Time-corrected AUC of cystatin C for Day 1 to Day 4 (72 hours after first dose of IMP) calculated as follows:\n\nThe area under the cystatin C concentration versus time curve following drug administration were calculated using timepoints at Day 1 (12 hour), Day 2 (24 hour), Day 3 (48 hour) and Day 4 (72 hour). The individual log-transformed cystatin C values were determined, and the AUC (utilizing planned times) were calculated using the right Riemann sum: AUC = 0.5 x cystatin C(12h) + 0.5 x cystatin C(24h) + 1 x cystatin C(48h) + 1 x cystatin C(72h) The time-corrected AUC (log-scale) was then calculated as AUC/3', 'unitOfMeasure': 'log(mg/L)/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Renal Replacement Therapy (Dialysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'Renal replacement therapy (dialysis treatment) required by any participant for any reason', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Number of Days Without Need for Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '90.0', 'upperLimit': '90.0'}, {'value': '90.0', 'groupId': 'OG001', 'lowerLimit': '90.0', 'upperLimit': '90.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '90 days', 'description': 'Number of days that participants were not requiring dialysis', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Major Adverse Kidney Event (MAKE) - SCr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'title': 'Day 30', 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '15.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'MAKE at Day 30 and Day 90, defined as death, any dialysis, or ≥25% reduction of eGFR compared to baseline.\n\neGFR calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using SCr.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'AKI Within 72 Hours Based on Cystatin C and UO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000'}, {'value': '40.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': 'AKI based on cystatin C and/or urine output (UO)', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'AKI Within 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000'}, {'value': '45.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'AKI based on SCr and/or UO criteria, or cystatin C and/or UO criteria', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Persistence of AKI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}, {'value': '14.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'AKI persistence, defined as an AKI (KDIGO definition) developing within 72 hours after first dose of IMP and with a duration of ≥72 hours', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Severity of AKI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'title': 'Stage 1', 'categories': [{'measurements': [{'value': '43.8', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}]}]}, {'title': 'Stage 2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '38.5', 'groupId': 'OG001'}]}]}, {'title': 'Stage 3', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'AKI severity stage 1, 2 or 3 per KDIGO criteria, with 1 being mildest stage and 3 being most severe stage.\n\nReference: KDIGO (2012). "Clinical Practice Guideline for Acute Kidney Injury." JOURNAL OF THE INTERNATIONAL SOCIETY OF NEPHROLOGY 2(1).', 'unitOfMeasure': 'percentage of participants with AKI', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Change in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing will be based on renal function at Day -1: Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'timeFrame': '90 days', 'description': 'Post-baseline changes in UACR and UPCR at Day 4, Day 30, and Day 90', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of RMC-035 (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '14.63', 'spread': '12.314', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': 'AUC(0-24) of RMC-035 concentrations in plasma (Day 3)', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of RMC-035 (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}], 'classes': [{'title': 'eGFR>=60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.59', 'spread': '25.046', 'groupId': 'OG000'}]}]}, {'title': 'eGFR<60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.62', 'spread': '3.989', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Cmax of RMC-035 concentrations in plasma Day 3', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Presence of Anti-drug Antibodies (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Presence of ADA at Day 1 (pre-surgery), Day 30, and Day 90; positive samples', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Characteristics of ADA (Cross-reactivity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Characteristics of ADA developed at Day 30 and Day 90 with regards cross-reactivity with endogenous alpha-1-microglobulin (A1M)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Peak SCr Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.32'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '0.20'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Change from baseline of peak SCr from baseline to Day 7', 'unitOfMeasure': 'mg/dL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Major Adverse Kidney Event (MAKE) - Cystatin C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'title': 'Day 30', 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}, {'value': '22.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'MAKE at Day 30 and Day 90, defined as death, any dialysis, or ≥25% reduction of eGFR compared to baseline.\n\neGFR calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using Cystatin C.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Major Adverse Kidney Event (MAKE) - SCr and Cystatin C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'title': 'Day 30', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}, {'value': '22.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'MAKE at Day 30 and Day 90, defined as death, any dialysis, or ≥25% reduction of eGFR compared to baseline.\n\neGFR calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using SCr and Cystatin C.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}, {'type': 'SECONDARY', 'title': 'Change in Serum Cystatin C Values Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'classes': [{'title': '12 hours', 'categories': [{'measurements': [{'value': '-0.15', 'groupId': 'OG000', 'lowerLimit': '-0.19', 'upperLimit': '0.11'}, {'value': '-0.26', 'groupId': 'OG001', 'lowerLimit': '-0.29', 'upperLimit': '-0.22'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '-0.04', 'groupId': 'OG000', 'lowerLimit': '-0.09', 'upperLimit': '-0.00'}, {'value': '-0.14', 'groupId': 'OG001', 'lowerLimit': '-0.18', 'upperLimit': '-0.10'}]}]}, {'title': '48 hours', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '-0.00', 'upperLimit': '0.09'}, {'value': '-0.03', 'groupId': 'OG001', 'lowerLimit': '-0.08', 'upperLimit': '0.02'}]}]}, {'title': '72 hours', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.12'}, {'value': '-0.00', 'groupId': 'OG001', 'lowerLimit': '-0.05', 'upperLimit': '0.04'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '-0.01', 'upperLimit': '0.10'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.06', 'upperLimit': '0.04'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.14'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '0.16'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.16'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.19'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Cystatin C measurement in serum at 12, 24, 48, and 72 hours, respectively, and at Day 7/discharge, Day 30 and Day 90', 'unitOfMeasure': 'mg/L', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'all dosed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was based on renal function on Day -1: Subjects with eGFR ≥60 mL/min/1.73m2 received 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 received 0.65 mg/kg (per dose) for all five doses Dosing occurred at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing was based on renal function at Day -1: Subjects with eGFR ≥60 mL/min/1.73m2 received 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 received 0.65 mg/kg (per dose) for all five doses Dosing occurred at time 0 and then after 6, 12, 24 and 48 hours.\n\nRMC-035: Concentrate for Solution for Infusion'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.\n\nPlacebo: Concentrate for Solution for Infusion'}, {'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': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', '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': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', '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': '86', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '171', '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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All dosed'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-08', 'size': 2627606, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-18T07:51', 'hasProtocol': True}, {'date': '2023-08-30', 'size': 1510502, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-19T02:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blind, adaptive, parallel group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}}, 'statusModule': {'whyStopped': 'Enrollment discontinued following DMC recommendation based on futility with regards to primary endpoint', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2021-11-08', 'resultsFirstSubmitDate': '2024-03-20', 'studyFirstSubmitQcDate': '2021-11-08', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-15', 'studyFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Developing AKI, as Defined Per Kidney Disease Improving Global Outcomes (KDIGO) Criteria', 'timeFrame': '72 hours', 'description': 'Percentage of subjects developing AKI based on Serum Creatinine and/or Urine Output per KDIGO definition'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve (AUC) of Serum Creatinine (SCr)', 'timeFrame': '72 hours', 'description': 'Time-corrected area under the curve (AUC) of serum creatinine calculated as follows:\n\nThe area under the SCr concentration versus time curve following drug administration were calculated using timepoints at Day 1 (12 hour), Day 2 (24 hour), Day 3 (48 hour) and Day 4 (72 hour). The individual log-transformed SCr values were determined, and the AUC (utilizing planned times) were calculated using the right Riemann sum: AUC = 0.5 x SCr(12h) + 0.5 x SCr(24h) + 1 x SCr(48h) + 1 x SCr(72h) The time-corrected AUC (log-scale) was then calculated as AUC/3'}, {'measure': 'Duration of AKI', 'timeFrame': '90 days', 'description': 'Duration of AKI defined as the number of days meeting the definition of AKI (KDIGO definition) starting within 72 hours after first dose of IMP until resolution'}, {'measure': 'Change in SCr Values Over Time', 'timeFrame': '90 days', 'description': 'SCr at 12, 24, 48, and 72 hours, respectively, and at Day 7/discharge, Day 30 and Day 90'}, {'measure': 'Peak Cystatin C Value', 'timeFrame': '7 days', 'description': 'Change from baseline of peak cystatin C from baseline to Day 7'}, {'measure': 'AUC of Cystatin C', 'timeFrame': '72 hours', 'description': 'Time-corrected AUC of cystatin C for Day 1 to Day 4 (72 hours after first dose of IMP) calculated as follows:\n\nThe area under the cystatin C concentration versus time curve following drug administration were calculated using timepoints at Day 1 (12 hour), Day 2 (24 hour), Day 3 (48 hour) and Day 4 (72 hour). The individual log-transformed cystatin C values were determined, and the AUC (utilizing planned times) were calculated using the right Riemann sum: AUC = 0.5 x cystatin C(12h) + 0.5 x cystatin C(24h) + 1 x cystatin C(48h) + 1 x cystatin C(72h) The time-corrected AUC (log-scale) was then calculated as AUC/3'}, {'measure': 'Number of Participants Requiring Renal Replacement Therapy (Dialysis)', 'timeFrame': '7 days', 'description': 'Renal replacement therapy (dialysis treatment) required by any participant for any reason'}, {'measure': 'Number of Days Without Need for Dialysis', 'timeFrame': '90 days', 'description': 'Number of days that participants were not requiring dialysis'}, {'measure': 'Major Adverse Kidney Event (MAKE) - SCr', 'timeFrame': '90 days', 'description': 'MAKE at Day 30 and Day 90, defined as death, any dialysis, or ≥25% reduction of eGFR compared to baseline.\n\neGFR calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using SCr.'}, {'measure': 'AKI Within 72 Hours Based on Cystatin C and UO', 'timeFrame': '72 hours', 'description': 'AKI based on cystatin C and/or urine output (UO)'}, {'measure': 'AKI Within 7 Days', 'timeFrame': '7 days', 'description': 'AKI based on SCr and/or UO criteria, or cystatin C and/or UO criteria'}, {'measure': 'Persistence of AKI', 'timeFrame': '7 days', 'description': 'AKI persistence, defined as an AKI (KDIGO definition) developing within 72 hours after first dose of IMP and with a duration of ≥72 hours'}, {'measure': 'Severity of AKI', 'timeFrame': '7 days', 'description': 'AKI severity stage 1, 2 or 3 per KDIGO criteria, with 1 being mildest stage and 3 being most severe stage.\n\nReference: KDIGO (2012). "Clinical Practice Guideline for Acute Kidney Injury." JOURNAL OF THE INTERNATIONAL SOCIETY OF NEPHROLOGY 2(1).'}, {'measure': 'Change in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR)', 'timeFrame': '90 days', 'description': 'Post-baseline changes in UACR and UPCR at Day 4, Day 30, and Day 90'}, {'measure': 'Pharmacokinetics of RMC-035 (AUC)', 'timeFrame': '4 days', 'description': 'AUC(0-24) of RMC-035 concentrations in plasma (Day 3)'}, {'measure': 'Pharmacokinetics of RMC-035 (Cmax)', 'timeFrame': '7 days', 'description': 'Cmax of RMC-035 concentrations in plasma Day 3'}, {'measure': 'Presence of Anti-drug Antibodies (ADA)', 'timeFrame': '90 days', 'description': 'Presence of ADA at Day 1 (pre-surgery), Day 30, and Day 90; positive samples'}, {'measure': 'Characteristics of ADA (Cross-reactivity)', 'timeFrame': '90 days', 'description': 'Characteristics of ADA developed at Day 30 and Day 90 with regards cross-reactivity with endogenous alpha-1-microglobulin (A1M)'}, {'measure': 'Peak SCr Value', 'timeFrame': '7 days', 'description': 'Change from baseline of peak SCr from baseline to Day 7'}, {'measure': 'Major Adverse Kidney Event (MAKE) - Cystatin C', 'timeFrame': '90 days', 'description': 'MAKE at Day 30 and Day 90, defined as death, any dialysis, or ≥25% reduction of eGFR compared to baseline.\n\neGFR calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using Cystatin C.'}, {'measure': 'Major Adverse Kidney Event (MAKE) - SCr and Cystatin C', 'timeFrame': '90 days', 'description': 'MAKE at Day 30 and Day 90, defined as death, any dialysis, or ≥25% reduction of eGFR compared to baseline.\n\neGFR calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using SCr and Cystatin C.'}, {'measure': 'Change in Serum Cystatin C Values Over Time', 'timeFrame': '90 days', 'description': 'Cystatin C measurement in serum at 12, 24, 48, and 72 hours, respectively, and at Day 7/discharge, Day 30 and Day 90'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '39318788', 'type': 'DERIVED', 'citation': 'Zarbock A, Larsson TE, Noiseux N, Mazer CD, Bohm J, Laflamme M, Matschke K, Burkert J, de Varennes B, Myjavec A, Boning A, Koyner JL, Engelman D, Reusch M, Thielmann M; AKITA investigators. Efficacy and safety of therapeutic alpha-1-microglobulin RMC-035 in reducing kidney injury after cardiac surgery: a multicentre, randomised, double-blind, parallel group, phase 2a trial. EClinicalMedicine. 2024 Sep 16;76:102830. doi: 10.1016/j.eclinm.2024.102830. eCollection 2024 Oct.'}, {'pmid': '37024249', 'type': 'DERIVED', 'citation': 'Mazer CD, Siadati-Fini N, Boehm J, Wirth F, Myjavec A, Brown CD, Koyner JL, Boening A, Engelman DT, Larsson TE, Renfurm R, de Varennes B, Noiseux N, Thielmann M, Lamy A, Laflamme M, von Groote T, Ronco C, Zarbock A. Study protocol of a phase 2, randomised, placebo-controlled, double-blind, adaptive, parallel group clinical study to evaluate the efficacy and safety of recombinant alpha-1-microglobulin in subjects at high risk for acute kidney injury following open-chest cardiac surgery (AKITA trial). BMJ Open. 2023 Apr 6;13(4):e068363. doi: 10.1136/bmjopen-2022-068363.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates RMC-035 compared to placebo for the prevention of acute kidney injury (AKI) in subjects who are at high risk for AKI following cardiac surgery. Half of the subjects will receive RMC-035 and the other half will receive placebo.', 'detailedDescription': 'This is a Phase 2, randomized, double-blind, adaptive, parallel group clinical study that will evaluate RMC-035 compared to placebo in subjects at high risk for acute kidney injury (AKI) following cardiac surgery. Subjects are randomized in a 1:1 ratio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Institutional Review Board/ International Ethics Committee approved Informed Consent obtained\n2. Ability to understand and comply with the study requirements and able to provide written informed consent\n3. Age ≥18 and \\<85 years\n4. Estimated glomerular filtration rate (eGFR) is ≥30 mL/min/1.73 m2\n5. Subject is scheduled for non-emergent coronary artery bypass grafting (CABG) surgery and/or valve surgery and/or ascending aorta aneurysm surgery with use of cardiopulmonary bypass (CPB), and AKI risk factors are present at screening\n6. Female subject is not of child-bearing potential, or agreeing not to become pregnant\n7. Female subject must not be breastfeeding\n8. Female subject must not donate ova\n9. Male subject and their female spouse/partner(s) who are of childbearing potential must be using a highly effective form of birth control\n10. Male subjects must not donate sperm\n11. Subject agrees not to participate in another interventional study\n\nExclusion Criteria:\n\n1. Medical condition that makes the subject unsuitable for study participation\n2. Scheduled for emergent surgeries (eg, aortic dissection)\n3. Scheduled for CABG and/or valve surgery and/or ascending aorta aneurysm surgery combined with additional non-emergent cardiac surgeries (eg, congenital heart defects)\n4. Scheduled to undergo transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR), or off-pump surgeries or left ventricular assist device (LVAD) implantation\n5. Experiences a cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices within 24 hours prior to surgery\n6. Requirement for defibrillator or permanent pacemaker, mechanical ventilation, intraaortic balloon pumping (IABP), LVAD, or other forms of mechanical circulatory support (MCS)\n7. Diagnosed with AKI (as defined by KDIGO criteria) within 3 months prior to surgery\n8. Required cardiopulmonary resuscitation within 14 days prior to cardiac surgery\n9. Ongoing sepsis or an untreated diagnosed clinically significant infection (viral or bacterial)\n10. Total bilirubin or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal (ULN)\n11. History of solid organ transplantation\n12. History of renal replacement therapy (RRT)\n13. Medical condition which requires active immunosuppressive treatment\n14. Severe allergic asthma\n15. Ongoing chemotherapy or radiation therapy for malignancy that may have an impact on kidney function\n16. Received an investigational medicinal product within the last 90 days (or within 5 half-lives of the investigational drug, whichever is longer)\n17. Subject has a known allergy to RMC-035 or one of its constituents, or has previously received RMC-035'}, 'identificationModule': {'nctId': 'NCT05126303', 'acronym': 'AKITA', 'briefTitle': 'Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guard Therapeutics AB'}, 'officialTitle': 'A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Adaptive, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery', 'orgStudyIdInfo': {'id': '21-ROS-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RMC-035', 'description': 'RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.\n\nDosing will be based on renal function at Day -1: Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR \\>30 and \\<60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours.', 'interventionNames': ['Drug: RMC-035']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Identical to RMC-035 arm except that the placebo contains no active ingredient.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RMC-035', 'type': 'DRUG', 'otherNames': ['ROSgard'], 'description': 'Concentrate for Solution for Infusion', 'armGroupLabels': ['RMC-035']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Concentrate for Solution for Infusion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48604', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Ohio Heart', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Bryan Heart', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '14621', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Regional Health - Rochester General Hospital', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '75226', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott and White Research Institute - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia (UVA) Health - University Hospital', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '53706', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Aurora Health Care - Aurora St. Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Hamilton', 'country': 'Canada', 'facility': 'Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Montreal', 'country': 'Canada', 'facility': 'CHUM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'country': 'Canada', 'facility': 'MUHC - Royal Victoria Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'country': 'Canada', 'facility': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Saint John', 'country': 'Canada', 'facility': 'St. John Regional Hospital', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'city': 'Toronto', 'country': 'Canada', 'facility': "Saint Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'University Hospital Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'University Hospital Motol - Charles University Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Herz- und Diabeteszentrum Nordrhein-Westfalen (NRW)', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinikum Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Herzzentrum Dresden GmbH', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Westdeutsches Herzzentrum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Giessen', 'country': 'Germany', 'facility': 'Universitätsklinikum Giessen und Marburg - Standort Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'city': 'Halle', 'country': 'Germany', 'facility': 'Universitätsklinikum Halle (Saale)', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'München', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': 'DE-481 49', 'city': 'Münster', 'country': 'Germany', 'facility': 'Münster University Hospital', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Córdoba', 'country': 'Spain', 'facility': 'Reina Sofia University Hospital', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital de La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Oviedo', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Santiago (CHUS)', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}], 'overallOfficials': [{'name': 'Tobias Agervald, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guard Therapeutics'}, {'name': 'Alexander Zarbock, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muenster University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guard Therapeutics AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}