Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-01-17 @ 3:44 PM
Study NCT ID:
NCT02372695
Status:
TERMINATED
Last Update Posted:
2015-02-26
First Post:
2013-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Paricalcitol Over Vessel Wall
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C084656', 'term': 'paricalcitol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'whyStopped': 'Protocol showed to be inappropriate for the evaluation of the selected patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-20', 'studyFirstSubmitDate': '2013-03-05', 'studyFirstSubmitQcDate': '2015-02-20', 'lastUpdatePostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention on vessels progression based on paricalcitol intake.', 'timeFrame': 'participants will be followed for the duration of whole study, an expected average of 1 year', 'description': 'Providing prospective results based on evidence of potential beneficial effects of paricalcitol, an analogue of vitamin D in the prevention / delay of progression of neoangiogenesis (vessels), atherosclerosis and vascular calcification.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nephropathy']}, 'descriptionModule': {'briefSummary': 'To provide evidence based prospectives of the potential benefit effects of paricalcitol, an analog of vitamin D, over the prevention / retardation of the progression of neoangiogenesis (vessels), atherosclerosis and vascular calcification.', 'detailedDescription': 'Providing prospective results based on evidence of potential beneficial effects of paricalcitol, an analogue of vitamin D in the prevention / delay of progression of neoangiogenesis (vessels), atherosclerosis and vascular calcification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 50 and 75 years.\n* Chronic kidney disease stage 5 D or 4-5 No D as calculated glomerular filtration rate (MDRD).\n* Concentration of intact parathyroid hormone (iPTH): 150-400 pg/ml.\n* Plasma concentrations of 25 (OH) vitamin D \\<30 ng/ml.\n* Without vitamin D supplementation for 3 months before the study.\n* Serum P\\> 3.8 mg / dl.\n* Serum Ca\\> 9.8 mg / dl.\n* No history of cardiovascular events (angina or myocardial infarction, stroke, peripheral arterial disease).\n* No exclusion criteria for the use of contrast.\n\nExclusion Criteria:\n\n* Allergic reaction to sulfur hexafluoride.\n* Recent unstable cardiac symptoms.\n* Patients with recent coronary intervention (\\<7 days)\n* Patients with class III and IV heart failure or severe arrhythmias.\n* Severe pulmonary hypertension.'}, 'identificationModule': {'nctId': 'NCT02372695', 'acronym': 'MICROBUB', 'briefTitle': 'Effect of Paricalcitol Over Vessel Wall', 'organization': {'class': 'INDUSTRY', 'fullName': 'Effice Servicios Para la Investigacion S.L.'}, 'officialTitle': 'Effect of Paricalcitol Over Vessel Wall: Pleiotropic Analogues Vitamin D Effects', 'orgStudyIdInfo': {'id': 'MICROBUB-2011-01'}, 'secondaryIdInfos': [{'id': '2011-002554-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Patient will take one pill of paricalcitol a day.', 'interventionNames': ['Drug: Paricalcitol']}, {'type': 'NO_INTERVENTION', 'label': 'Usual treatment.', 'description': 'Patient allocated to this arm will only take his/her habitual treatment'}], 'interventions': [{'name': 'Paricalcitol', 'type': 'DRUG', 'otherNames': ['Zemplar- 1 ug/day'], 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Maria Vittoria Arcidiacono, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Arnau de Vilanova de Lleida.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Effice Servicios Para la Investigacion S.L.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Jaume Arnó Renal Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}