Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-04-17 @ 9:27 PM
Study NCT ID:
NCT01250405
Status:
COMPLETED
Last Update Posted:
2014-04-07
First Post:
2010-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069449', 'term': 'Cinacalcet'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-04', 'studyFirstSubmitDate': '2010-11-26', 'studyFirstSubmitQcDate': '2010-11-29', 'lastUpdatePostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial stiffness', 'timeFrame': 'Arterial stiffness with be measured after 1 week with placebo and after 1 week with cinacalcet'}], 'secondaryOutcomes': [{'measure': 'Ventricular function', 'timeFrame': 'Ventricular function with be measured after 1 week with placebo and after 1 week with cinacalcet'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '28538380', 'type': 'DERIVED', 'citation': 'Poulin A, Bellemare PL, Fortier C, Mac-Way F, Desmeules S, Marquis K, Gaudreault V, Lebel M, Agharazii M. Acute effects of cinacalcet on arterial stiffness and ventricular function in hemodialysis patients: A randomized double-blinded crossover study. Medicine (Baltimore). 2017 May;96(21):e6912. doi: 10.1097/MD.0000000000006912.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine whether reduction of serum calcium concentration by cinacalcet leads to reduction of mean blood pressure adjusted c-fPWV. The secondary objectives are to study the effects of calcium reduction on 1) carotid-radial PWV (c-rPWV), 2) common carotid artery (CCA) biomechanics, 3) pulse wave profile and cardiac function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic (\\> 3 months) hemodialysis population of \\> 18 years old\n* PTH \\> 300 ng/L\n* corrected Ca \\> 2.10 mmol/L\n* stable hypertensive drugs (\\> 1 month)\n* stable doses of phosphate binders and dialysis calcium concentration\n* palpable femoral pulse\n* systolic BP of 90-180 mmHg\n* expected survival of \\> 6 months\n\nExclusion Criteria:\n\n* hemodialysis \\> 3 years\n* acute infection\n* history of myocardial infarction or stroke within the past 3 months\n* inability to consent\n* intolerance to cinacalcet\n* inadequate birth control'}, 'identificationModule': {'nctId': 'NCT01250405', 'acronym': 'ECIRA', 'briefTitle': 'Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'CA2009-0008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cinacalcet', 'interventionNames': ['Drug: Cinacalcet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cinacalcet', 'type': 'DRUG', 'description': 'One sequence receives Cinacalcet 30mg /d for 7 days followed by placebo for 7 days', 'armGroupLabels': ['Cinacalcet']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One sequence receives placebo for 7 days followed by Cinacalcet 30mg/d for 7 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1R2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Karine Marquis', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Mohsen Agharazii, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laval University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professionnelle de recherche', 'investigatorFullName': 'Karine Marquis', 'investigatorAffiliation': 'Laval University'}}}}