Treatment Adhesion in Dialysis Patients Treated With Cinacalcet (MEMS-cinac)
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|ClinicalTrials.gov Identifier: NCT01573520|
Recruitment Status : Completed
First Posted : April 9, 2012
Last Update Posted : January 29, 2016
Controlling secondary hyperparathyroidism (sHPT) in maintenance hemodialysis (MHD) patients is cumbersome, partly due to patient's non-adherence to prescribed drugs.
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.
|Condition or disease||Intervention/treatment||Phase|
|Hyperparathyroidism Chronic Kidney Disease||Other: Monitoring of drug adherence||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial Comparing an Integrated Care Approach Using Electronic Cinacalcet Adherence Data Versus Usual Care to Improve Secondary Hyperparathyroidism in Hemodialysis Patients|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
|No Intervention: usual care|
Active Comparator: adherence intervention arm
Monitoring drug adherence to guide treatment
Other: 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 Name: Compliance monitoring
- Relative change from baseline in cinacalcet dose at 6 months [ Time Frame: baseline and 6 months ]
- (6-months dose - baseline dose)/ baseline dose %
- dose expressed in mg/d
- absolute change from baseline in iPTH at 6 months [ Time Frame: baseline and 6 months ]
- 6-months iPTH - baseline iPTH
- iPTH (=intact parathyroid hormone), unit ng/l
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573520
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, 1011|
|Principal Investigator:||Michel Burnier, MD||Centre Hospitalier Universitaire Vaudois|