Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-14 @ 4:08 PM
Study NCT ID:
NCT02498457
Status:
UNKNOWN
Last Update Posted:
2015-07-15
First Post:
2015-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects and Safety of Low Calcium Dialysis on Coronary Artery Calcification in Maintenance Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-07-20', 'releaseDate': '2017-09-29'}], 'estimatedResultsFirstSubmitDate': '2017-09-29'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-14', 'studyFirstSubmitDate': '2015-07-13', 'studyFirstSubmitQcDate': '2015-07-14', 'lastUpdatePostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Changes in coronary artery calcification after 1 year's treatment", 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'The intolerance of low calcium dialysis because of adverse reactions associated with dialysis were recorded during the study', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['maintenance hemodialysis patients', 'coronary artery calcification', 'low calcium dialysate', 'effects', 'safety'], 'conditions': ['Coronary Artery Calcification']}, 'descriptionModule': {'briefSummary': 'This study aim to observe the preventive effect and the long term safety of low calcium dialysis on coronary artery calcification in Maintenance hemodialysis (MHD) patients.', 'detailedDescription': 'MHD patients recruited in this study were randomly divided into two groups: routine dialysis group (with dialysate calcium concentration 1.5mmol/L) and low calcium dialysis group (with dialysate calcium concentration 1.25mmol/L). All patients were dialyzed thrice weekly for 4 hours with a bicarbonate-based solution. They were followed up in every dialysis interview during the 1-year study, the occurrence of all adverse reactions associated with dialysis were recorded during the study. All patients received heart spiral CT examination before and at the end of the study. Coronary artery calcification was assessed by a certain professional who was not affiliated to the dialysis center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maintenance hemodialysis (MHD) patients who dialyze thrice weekly in our hospital with serum iPTH \\<500pg/ml, adjusted serum calcium≧8.4mg/dl in two serial tests.\n* Patients who have no chronic infection or malignant tumour and with relatively stable heart and lung function.\n* Patients who signed informed consent documents at the time of enrollment in the study.\n\nExclusion Criteria:\n\n* Patients whose heart or lung function are poor, or with unstable hemodynamics.\n* Patients who are diagnosed active pulmonary tuberculosis, AIDS, malignant tumour, or decompensated liver cirrhosis.\n* Patients who are unable or unwilling to cooperate with the researchers in the treatment and follow-up.'}, 'identificationModule': {'nctId': 'NCT02498457', 'briefTitle': 'The Effects and Safety of Low Calcium Dialysis on Coronary Artery Calcification in Maintenance Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'The First Affiliated Hospital of Chongqing Medical University', 'orgStudyIdInfo': {'id': '1stChongqingMU snkxia1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'low calcium dialysis', 'description': 'patients in this group will be dialyzed using a dialysate with a calcium concentration 1.25mmol/L.', 'interventionNames': ['Other: low calcium dialysis']}, {'type': 'OTHER', 'label': 'Routine dialysis', 'description': 'Patients in this groups will be dialyzed using routine dialysate with a calcium concentration 1.5mmol/L.', 'interventionNames': ['Other: low calcium dialysis']}], 'interventions': [{'name': 'low calcium dialysis', 'type': 'OTHER', 'description': 'patients in this group will receive low calcium dialysis for 1 year.', 'armGroupLabels': ['Routine dialysis', 'low calcium dialysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Hao, MD', 'role': 'CONTACT', 'email': 'ghzxgckd@163.com', 'phone': '86-23-89012409'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Yunfeng Xia, Dr.', 'role': 'CONTACT', 'email': 'xyf0920@126.com', 'phone': '86-23-89012256'}], 'overallOfficials': [{'name': 'Hua Gan, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Nephrology', 'investigatorFullName': 'Yunfeng Xia', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-09-29', 'type': 'RELEASE'}, {'date': '2018-07-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Yunfeng Xia, Department of Nephrology, First Affiliated Hospital of Chongqing Medical University'}}}}