Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-28 @ 11:35 AM
Study NCT ID:
NCT03539861
Status:
TERMINATED
Last Update Posted:
2023-01-17
First Post:
2018-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006435', 'term': 'Renal Dialysis'}], 'ancestors': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lenar@med.umich.edu', 'phone': '734-763-9041', 'title': 'Lenar Yessayan', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '8 days', 'eventGroups': [{'id': 'EG000', 'title': 'Hemodialysis', 'description': 'The treatment arm (all participants are in this arm) is done in two phases that are described below:\n\nTreatment 1 will be standard hemodialysis (no device).\n\nTreatment 2 will be hemodialysis with the study device. Of importance, this 5 hour session is planned to ensure adequate solute clearance but with only 4 hour high ultrafiltration to achieve the patients dry weight.\n\nHemodialysis: Each patient will receive two hemodialysis treatments while on this study. The first hemodialysis treatment will be standard of care hemodialysis. The second treatment will be the experimental hemodialysis treatment using the Selective cytopheretic device.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Regional Wall Abnormalities Identified on Echocardiogram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemodialysis', 'description': 'The treatment arm (all participants are in this arm) is done in two phases that are described below:\n\nTreatment 1 will be standard hemodialysis (no device).\n\nTreatment 2 will be hemodialysis with the study device. Of importance, this 5 hour session is planned to ensure adequate solute clearance but with only 4 hour high ultrafiltration to achieve the patients dry weight.\n\nHemodialysis: Each patient will receive two hemodialysis treatments while on this study. The first hemodialysis treatment will be standard of care hemodialysis. The second treatment will be the experimental hemodialysis treatment using the Selective cytopheretic device.'}], 'timeFrame': 'Baseline, 5 hour, 24 hours', 'description': 'Regional wall motion will be scored using a standard wall motion scoring scheme. (1= normal; 2=hypokinetic; 3= akinetic; 4=dyskinetic). Scores will be tabulated for each of 16 predefined segments and a global wall motion score calculated as the sum of individual scores divided by the number visualized segments.', 'reportingStatus': 'POSTED', 'populationDescription': 'Regional wall motion was not able to be evaluated for one participant because of arrhythmia. Because sharing data about the other individual could violate privacy concerns, it is not analyzed or displayed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Ionized Calcium (iCa)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemodialysis', 'description': 'The treatment arm (all participants are in this arm) is done in two phases that are described below:\n\nTreatment 1 will be standard hemodialysis (no device).\n\nTreatment 2 will be hemodialysis with the study device. Of importance, this 5 hour session is planned to ensure adequate solute clearance but with only 4 hour high ultrafiltration to achieve the patients dry weight.\n\nHemodialysis: Each patient will receive two hemodialysis treatments while on this study. The first hemodialysis treatment will be standard of care hemodialysis. The second treatment will be the experimental hemodialysis treatment using the Selective cytopheretic device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hour 1, hour 2, hour 3, hour 4, hour 5', 'description': 'Number of participants who experienced a clinically significant change in systemic ionized calcium compared to reference range: 1.12 to 1.30.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemodialysis', 'description': 'The treatment arm (all participants are in this arm) is done in two phases that are described below:\n\nTreatment 1 will be standard hemodialysis (no device).\n\nTreatment 2 will be hemodialysis with the study device. Of importance, this 5 hour session is planned to ensure adequate solute clearance but with only 4 hour high ultrafiltration to achieve the patients dry weight.\n\nHemodialysis: Each patient will receive two hemodialysis treatments while on this study. The first hemodialysis treatment will be standard of care hemodialysis. The second treatment will be the experimental hemodialysis treatment using the Selective cytopheretic device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Hour 5, 24 hours', 'description': 'Number of participants who experienced a clinically significant change in hemoglobin who experience a change of more than 10% of baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hemodialysis', 'description': 'The treatment arm (all participants are in this arm) is done in two phases that are described below:\n\nTreatment 1 will be standard hemodialysis (no device).\n\nTreatment 2 will be hemodialysis with the study device. Of importance, this 5 hour session is planned to ensure adequate solute clearance but with only 4 hour high ultrafiltration to achieve the patients dry weight.\n\nHemodialysis: Each patient will receive two hemodialysis treatments while on this study. The first hemodialysis treatment will be standard of care hemodialysis. The second treatment will be the experimental hemodialysis treatment using the Selective cytopheretic device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hemodialysis', 'description': 'The treatment arm (all participants are in this arm) is done in two phases that are described below:\n\nTreatment 1 will be standard hemodialysis (no device).\n\nTreatment 2 will be hemodialysis with the study device. Of importance, this 5 hour session is planned to ensure adequate solute clearance but with only 4 hour high ultrafiltration to achieve the patients dry weight.\n\nHemodialysis: Each patient will receive two hemodialysis treatments while on this study. The first hemodialysis treatment will be standard of care hemodialysis. The second treatment will be the experimental hemodialysis treatment using the Selective cytopheretic device.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '25-30', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '62-68', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Black or African-American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-26', 'size': 692472, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-22T16:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'COVID- pandemic, nursing shortages. enrolled two patients then not enough nurses in dialysis unit to be able to attend to patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-18', 'studyFirstSubmitDate': '2018-05-16', 'resultsFirstSubmitDate': '2022-12-18', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-18', 'studyFirstPostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Regional Wall Abnormalities Identified on Echocardiogram', 'timeFrame': 'Baseline, 5 hour, 24 hours', 'description': 'Regional wall motion will be scored using a standard wall motion scoring scheme. (1= normal; 2=hypokinetic; 3= akinetic; 4=dyskinetic). Scores will be tabulated for each of 16 predefined segments and a global wall motion score calculated as the sum of individual scores divided by the number visualized segments.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Ionized Calcium (iCa)', 'timeFrame': 'Hour 1, hour 2, hour 3, hour 4, hour 5', 'description': 'Number of participants who experienced a clinically significant change in systemic ionized calcium compared to reference range: 1.12 to 1.30.'}, {'measure': 'Number of Participants With an Adverse Event Based on the Clinical Laboratory Measurement: Hemoglobin', 'timeFrame': 'Baseline, Hour 5, 24 hours', 'description': 'Number of participants who experienced a clinically significant change in hemoglobin who experience a change of more than 10% of baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['End Stage Renal Disease', 'Hemodialysis', 'Chronic Kidney Disease Stage 5'], 'conditions': ['End Stage Renal Disease', 'Acute Kidney Injury', 'Chronic Kidney Disease Stage 5']}, 'descriptionModule': {'briefSummary': 'Hemodialysis is a therapy that filters waste, removes extra fluid and balances electrolytes. In hemodialysis, blood is removed from the body and filtered through a man-made membrane called a dialyzer, and then the filtered blood is returned to the body. Hemodialysis is associated with injury to the heart muscle called myocardial stunning. This may occur for many reasons, including removal of fluid during dialysis or low blood pressure. Initial ischemia and subsequent white blood cell infiltration into the injured myocardium play a critical role in the degree of myocardial ischemia reperfusion injury.\n\nIn this study an additional man made membrane (selective cytopheretic device) and tubing will be added to the dialysis circuit. The device shifts the circulating white blood cells pool to a less inflammatory phenotype. Researchers believe the selective cytopheretic device will alter the phenotype of circulating white blood cells which play a role in myocardial stunning.\n\nThe purpose of this study is to evaluate whether the selective cytopheretic device will reduce myocardial stunning events in hemodialysis patients. It will also report the rate of adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End-stage renal disease (Chronic Kidney Disease Stage 5)\n* Receiving hemodialysis 3 times/week for over 3 months\n* Baseline blood pressure before hemodialysis has been ≥ 100/50 over preceding 4 weeks\n* Recurrent weight gain between hemodialysis sessions\n\nExclusion Criteria:\n\n* Any active inflammatory condition (e.g., gout, systemic lupus erythematosus flare, hepatitis B or C infection, allograft rejection, subcutaneous injection of illicit drugs, "skin popping")\n* Treatment with immunosuppressive therapy within 30 days of study\n* Blood levels within a specified range\n* Woman who is pregnant, breast feeding a child, or is trying to become pregnant\n* Heart weakness or failure'}, 'identificationModule': {'nctId': 'NCT03539861', 'acronym': 'ESRD', 'briefTitle': 'Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (ERSD)', 'orgStudyIdInfo': {'id': 'HUM00125836'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hemodialysis', 'description': 'The treatment arm (all participants are in this arm) is done in two phases that are described below:\n\nTreatment 1 will be standard hemodialysis (no device).\n\nTreatment 2 will be hemodialysis with the study device. Of importance, this 5 hour session is planned to ensure adequate solute clearance but with only 4 hour high ultrafiltration to achieve the patients dry weight.', 'interventionNames': ['Device: Hemodialysis']}], 'interventions': [{'name': 'Hemodialysis', 'type': 'DEVICE', 'otherNames': ['Selective cytopheretic device', 'SCD', 'SCD filter anticoagulated with regional citrate'], 'description': 'Each patient will receive two hemodialysis treatments while on this study. The first hemodialysis treatment will be standard of care hemodialysis. The second treatment will be the experimental hemodialysis treatment using the Selective cytopheretic device.', 'armGroupLabels': ['Hemodialysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'The University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Lenar Yessayan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Michigan Department of Internal Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Renal Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine, Medical School', 'investigatorFullName': 'Lenar Yessayan', 'investigatorAffiliation': 'University of Michigan'}}}}