Treatment Adhesion in Dialysis Patients Treated With Cinacalcet
NCT ID: NCT01573520
Last Updated: 2016-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2010-01-31
2011-11-30
Brief Summary
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The 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.
The 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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usual care
No interventions assigned to this group
adherence intervention arm
Monitoring drug adherence to guide treatment
Monitoring of drug adherence
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.
Interventions
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Monitoring of drug adherence
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients on hemodialysis since more than 3 months
* 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)
* 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
Exclusion Criteria
* Inability to understand the protocol
* Mental diseases
* Patients suffering from cancer or having a short life expectancy (\<6 months)
* Patients planned for a parathyroidectomy
* Patients having had a parathyroidectomy
* Patient already enrolled in a Cinacalcet-HCL protocol
* Symptomatic hypocalcaemia or total serum calcium \< 1.87 mmol/l
18 Years
ALL
No
Sponsors
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Michel Burnier
OTHER
Responsible Party
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Michel Burnier
Centre Hospitalier Universitaire Vaudois
Principal Investigators
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Michel Burnier, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire Vaudois
Locations
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Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Countries
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Other Identifiers
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268/09
Identifier Type: -
Identifier Source: org_study_id
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