Treatment Adhesion in Dialysis Patients Treated With Cinacalcet (MEMS-cinac)
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.
|Hyperparathyroidism Chronic Kidney Disease||Other: Monitoring of drug adherence||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- 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
|Study Start Date:||January 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573520
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, 1011|
|Principal Investigator:||Michel Burnier, MD||Centre Hospitalier Universitaire Vaudois|