MEMS-cinac: Treatment Adhesion in Dialysis Patients Treated With Cinacalcet

Sponsor

Michel Burnier (Other)

Overall Status

Completed

CT.gov ID

NCT01573520

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Compliance monitoring

Arm

Intervention/Treatment

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 Names:

Compliance monitoring

Outcome Measures

Primary Outcome Measures

Relative change from baseline in cinacalcet dose at 6 months [baseline and 6 months]
(6-months dose - baseline dose)/ baseline dose % dose expressed in mg/d

Secondary Outcome Measures

absolute change from baseline in iPTH at 6 months [baseline and 6 months]
6-months iPTH - baseline iPTH iPTH (=intact parathyroid hormone), unit ng/l

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age > 18 years
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