Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT01573520
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2012-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Adhesion in Dialysis Patients Treated With Cinacalcet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2012-03-23', 'studyFirstSubmitQcDate': '2012-04-05', 'lastUpdatePostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative change from baseline in cinacalcet dose at 6 months', 'timeFrame': 'baseline and 6 months', 'description': '* (6-months dose - baseline dose)/ baseline dose %\n* dose expressed in mg/d'}], 'secondaryOutcomes': [{'measure': 'absolute change from baseline in iPTH at 6 months', 'timeFrame': 'baseline and 6 months', 'description': '* 6-months iPTH - baseline iPTH\n* iPTH (=intact parathyroid hormone), unit ng/l'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['compliance', 'dialysis', 'hyperparathyroidism'], 'conditions': ['Hyperparathyroidism', 'Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': "Controlling secondary hyperparathyroidism (sHPT) in maintenance hemodialysis (MHD) patients is cumbersome, partly due to patient's non-adherence to prescribed drugs.\n\nThe main objective of this study was to assess whether an integrated care (IC) approach, in which adherence data are integrated in the decisional process, led to improved therapeutic control of secondary hyperparathyroidsm and higher percentages of bone metabolism targets as compared to a usual care (UC) approach, in which biological values represent the main stem of the decisional process.\n\nThe predefined hypothesis was that patients of the IC group should reach the iPTH targets using 25% less doses of cinacalcet at 6 months than those of the UC group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Patients on hemodialysis since more than 3 months\n* Patients with secondary hyperparathyroidism treated with Cinacalcet-HCl at a stable dose (30mg/day or more) for at least 1 month before enrolment and indication to Cinacalcet-HCL therapy (iPTH in target values or over target values)\n* Patients with secondary hyperparathyroidism with indication to be treated with Cinacalcet-HCL (iPTH ≥ locally pre-defined targets). In this case, patients should be treated at least 1 month with stable dose Cinacalcet-HCL before enrolment\n\nExclusion Criteria:\n\n* Intolerance to Cincalcet-HCL\n* Inability to understand the protocol\n* Mental diseases\n* Patients suffering from cancer or having a short life expectancy (\\<6 months)\n* Patients planned for a parathyroidectomy\n* Patients having had a parathyroidectomy\n* Patient already enrolled in a Cinacalcet-HCL protocol\n* Symptomatic hypocalcaemia or total serum calcium \\< 1.87 mmol/l'}, 'identificationModule': {'nctId': 'NCT01573520', 'acronym': 'MEMS-cinac', 'briefTitle': 'Treatment Adhesion in Dialysis Patients Treated With Cinacalcet', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'A Randomized Trial Comparing an Integrated Care Approach Using Electronic Cinacalcet Adherence Data Versus Usual Care to Improve Secondary Hyperparathyroidism in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '268/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'usual care'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'adherence intervention arm', 'description': 'Monitoring drug adherence to guide treatment', 'interventionNames': ['Other: Monitoring of drug adherence']}], 'interventions': [{'name': 'Monitoring of drug adherence', 'type': 'OTHER', 'otherNames': ['Compliance monitoring'], 'description': 'In the IC group, biological and drug adherence results are shown and discussed through a nephrologists leaded semi-structured motivation interviews at interval of 2 months.', 'armGroupLabels': ['adherence intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Michel Burnier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Vaudois'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michel Burnier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Centre Hospitalier Universitaire Vaudois', 'investigatorFullName': 'Michel Burnier', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}