Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:31 AM
Study NCT ID:
NCT00485706
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2007-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D006934', 'term': 'Hypercalcemia'}, {'id': 'D061205', 'term': 'Vascular Calcification'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'lastUpdateSubmitDate': '2018-10-15', 'studyFirstSubmitDate': '2007-06-12', 'studyFirstSubmitQcDate': '2007-06-12', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-06-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation between calcium increase and pulse wave velocity', 'description': 'correlation between calcium increase and pulse wave velocity'}, {'measure': 'correlation between calcium change and pth change', 'description': 'correlation between calcium change and pth change'}], 'secondaryOutcomes': [{'measure': 'correlation between calcium increase and vascular calcifications', 'description': 'correlation between calcium increase and vascular calcifications'}, {'measure': 'correlation between calcium change and bone markers', 'description': 'correlation between calcium change and bone markers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dialysis', 'vascular calcification', 'bone mineralism', 'arterial stiffness', 'bone metabolism', 'chronic kidney disease'], 'conditions': ['Kidney Disease', 'Hypercalcemia']}, 'descriptionModule': {'briefSummary': 'Renal patients have an increased risk for cardiovascular complications. There is also increased vascular calcification and bone metabolism is similarly abnormal in patients with chronic kidney disease.\n\nIn dialysis patients frequent episodes of hypercalcaemia occur. In a healthy bone structure those episodes of hypercalcemia are buffered by the bone. The absence of bone buffering capacity in dialysis patients can be a mechanism for vascular calcifications.', 'detailedDescription': 'Study hypothesis.\n\nPatient with a higher ā Calcium (Calcium post - Calcium pre) have a diminished bone buffering capacity indicative for adynamic bone disease compared with patients with smaller ā Calcium.\n\nThis may result in higher extraosseous calcification and higher pulse wave velocity\n\nā PTH/ā Calcium may reflect the sensitivity and density of the calcium receptors; this may reflect parathyroid "health"'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* maintenance hemodialysis patients\n\nExclusion Criteria:\n\n* dialysis \\<3 months\n* aortobifemoral graft\n* calcium level predialysis \\>10.5 mg/dl'}, 'identificationModule': {'nctId': 'NCT00485706', 'briefTitle': 'Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'ML4181'}, 'secondaryIdInfos': [{'id': 'S50455'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'high calcium dialysate', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'kathleen Claes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Gasthuisberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}