Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-26 @ 4:47 PM
Study NCT ID:
NCT05032651
Status:
UNKNOWN
Last Update Posted:
2021-10-13
First Post:
2021-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of a Novel Artificial Intelligence Assisted Platform to Assess Optimal Dosing and Treatment Strategy of Erythropoiesis-stimulating Agents (ESA) in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomization period All eligible subjects will be randomized 1:1 by their age, gender, and HD vintage into control arm and intervention arm. After randomization, the study subject will enter the study after the nearest Hb measurement coming.\n\nStudy period'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-12-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2021-08-31', 'studyFirstSubmitQcDate': '2021-08-31', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemoglobin (Hb) levels', 'timeFrame': '6 monthes', 'description': 'Maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.'}], 'secondaryOutcomes': [{'measure': 'the target range (10-12gm/dl)', 'timeFrame': '6 monthes', 'description': 'The Proportion of Participants with haemoglobin within the target range (10-12gm/dl)'}, {'measure': 'The Proportion of Participants Who Received a Whole Blood or Red Blood Cell Transfusion', 'timeFrame': '6 monthes', 'description': 'The Proportion of Participants Who Received a Whole Blood or Red Blood Cell Transfusion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['End Stage Renal Disease', 'Erythropoiesis stimulating agent', 'Artificial intelligence assisted platform'], 'conditions': ['End Stage Renal Disease on Dialysis']}, 'descriptionModule': {'briefSummary': "It has been known well for a long time that End stage renal disease (ESRD) patients usually need ESA to maintain their hemoglobin (Hb) to improve both mortality as well as quality of life. Later, several large-scale RCTs showing normalization of Hb in this population increased the risk of thromboembolic event, which leaded current guidelines to recommend the therapeutic goal for anemia in ESRD should be within a range (usually between 10-12 gm/dl) rather than above or below a certain level (or value). In addition to ESA dose, many factors contribute to the severity of anemia in this population, such as iron status, chronic blood loss, adequacy of dialysis, chronic inflammation, renal wasting, et al. To put all these factors together, maintaining the Hb levels within the target level is a challenge to physician. It was reported that only one third of Hb within the target at any given time. Our data showed, for those under maintenance hemodialysis and without any blood transfusion in observation period, near two third of patients' Hb level were within the target range.", 'detailedDescription': 'For better anemia management, NKF-K/DOQI developed and published guidelines using protocol or algorithm for EPO prescription.6 Recently, artificial intelligence (AI) has been widely applied to medicine in the field of reducing human error, robotic surgical system and decision- making aid. Since then, there were several studies working on decision making programs to set up model of predicting the ESA dose needed for target Hb level. Artificial neural network (ANN) model is most commonly used for ESA dose-response prediction. However, the effectiveness of these kinds of AI is not confirmed clinically and the result not satisfactory. In other words, it is still inconclusive whether contemporary AI has any role in decision making aid when prescribing ESA dose for dialysis patient, a typical trial and error which AI supposed should be very helpful with.\n\nBased on the mentioned above, we are going to conduct this clinical try to test the hypothesis that AI is not inferior to physician in prescribing ESA dose for hemodialysis patients to maintain hemoglobin(Hb) level to meet the target'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. signed informed consent\n2. Age older than 20 year old.\n3. End stage renal disease under regular hemodialysis with three times per week and duration of each session at least 4 hours\n4. Having at least consecutive 6 months data of both Hb and biochemical study during dialysis before enrollment and at least one Hb level within the range of 11-12 g/dl\n5. Having at least one prescription of ESA supplement to keep Hb within the range of 10-12 g/dl in the past 6 months before the enrollment\n6. Having received ESA of the same brand at least 6 months before the enrollment\n\nExclusion Criteria:\n\n1. Ever receiving blood transfusion in the past 12 months\n2. Active bleeding with blood loss more than 250cc in 3 months before the enrollment\n3. Active infection or malignancy\n4. Study subject can not follow with the study protocol\n\nEnd of Study\n\nThe eligible subject will not be allowed to continue the study once informed consent is withdrawn or event happening meets the following criteria:'}, 'identificationModule': {'nctId': 'NCT05032651', 'acronym': 'AI', 'briefTitle': 'Use of a Novel Artificial Intelligence Assisted Platform to Assess Optimal Dosing and Treatment Strategy of Erythropoiesis-stimulating Agents (ESA) in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)', 'orgStudyIdInfo': {'id': 'KMUHIRB-F(I)-20210040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GROUP A-AI (model) Arm Description:', 'description': 'Artificial intelligence assisted platform supported system for the clinical physicians to prescribe ESA dose to maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.', 'interventionNames': ['Device: novel artificial intelligence assisted platform']}, {'type': 'EXPERIMENTAL', 'label': 'GROUP B-AI (model) Arm Description:', 'description': 'ESA dose prescribed by clinical physicians as regular care to maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.', 'interventionNames': ['Device: novel artificial intelligence assisted platform']}], 'interventions': [{'name': 'novel artificial intelligence assisted platform', 'type': 'DEVICE', 'description': 'Use of a novel artificial intelligence assisted platform', 'armGroupLabels': ['GROUP A-AI (model) Arm Description:', 'GROUP B-AI (model) Arm Description:']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'CHEN YI PEI', 'role': 'CONTACT', 'email': 'joanna9504@gmail.com', 'phone': '07-3121101', 'phoneExt': '7901'}], 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Ping-Hsun Wu, PhD', 'role': 'CONTACT', 'email': '970392KMUH@gmail.com', 'phone': '07-3121101', 'phoneExt': '7351'}, {'name': 'YI-PEI CHEN', 'role': 'CONTACT', 'email': 'joanna9504@gmail.com', 'phone': '07-3121101', 'phoneExt': '7901'}], 'overallOfficials': [{'name': 'Ping-Hsun Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Sun Yat-sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}