Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-31 @ 11:03 PM
Study NCT ID:
NCT07170761
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers and Event Patterns of Vascular Disease in Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D012080', 'term': 'Chronic Kidney Disease-Mineral and Bone Disorder'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012279', 'term': 'Rickets'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 475}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '1, 2 and 3 years', 'description': 'All-causes, the date of death will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Cause-specific mortality', 'timeFrame': '1, 2 and 3 years', 'description': 'The cause of death will be recorded.'}, {'measure': 'MACE', 'timeFrame': '1, 2 and 3 years', 'description': 'The number of participants with, the date and cause of MACE (a composite outcome measure of non-fatal and fatal stroke, myocardial infarction, acute heartfailure and sudden cardiac death) will be recorded from medical record review.'}, {'measure': 'The number of participants with hospitalisation for Infection', 'timeFrame': '1, 2 and 3 years', 'description': 'The number and dates of hospitalisations for any infectious diseases (such as pneumonia, sepsis or urinary tract infection) will be recorded from medical record review.'}, {'measure': 'The number of participants with hospitalisation for Heart failure', 'timeFrame': '1, 2 and 3 years', 'description': 'The number and dates of hospitalisations for heart failure (such as acute heart failure or decompensated chronic heart failure) will be recorded from medical record review.'}, {'measure': 'The number of participants with Fractures', 'timeFrame': '1, 2 and 3 years', 'description': 'The number and dates of fractures (classified by anatomical site, such as hip, vertebral, or upper limb) will be recorded from medical record review.'}, {'measure': 'The number of participants with Bleeding events', 'timeFrame': '1, 2 and 3 years', 'description': 'The number and dates of bleeding events (classified as major or minor according to ISTH definition) will be recorded from medical record review.'}, {'measure': 'The number of participants with Interventions for vascular diseases', 'timeFrame': '1, 2 and 3 years', 'description': 'The number and dates of surgical and endovascular interventions (such as revascularization, bypass or amputation) for atherosclerotic cardiovascular diseases (such as coronary and peripheral artery disease) will be recorded from medical record review.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vascular Disease', 'CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder']}, 'descriptionModule': {'briefSummary': 'Parathyroid hormone (PTH) remains the central biomarker to classify CKD-metabolic bone disease (CKD-MBD) in hemodialysis patients. While PTH-values are known to be associated with adverse outcomes, interventional studies have failed to show a benefit of pharmacological modulation of PTH levels on hard clinical outcomes. To address this gap, the investigators explored alternative markers of bone metabolism, vascular calcification and inflammation in association to prospective event patterns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prevalent, chronic hemodialysis patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable hemodialysis \\> 3 months duration\n\nExclusion Criteria:\n\n* Pregnancy\n* Acute infections with antibiotic treatment'}, 'identificationModule': {'nctId': 'NCT07170761', 'acronym': 'HEMOcalc', 'briefTitle': 'Biomarkers and Event Patterns of Vascular Disease in Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Cross-sectional Biomarker Study for Vascular Calcification in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '34-322 ex 21/22'}}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medical University Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Kathrin Eller, Univ.-Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Nephrology, Department of Internal Medicine, Medical University of Graz, Graz, Austria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'LKH Feldkirch', 'class': 'UNKNOWN'}, {'name': 'Elisabethinen Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}