Treatment Adhesion in Dialysis Patients Treated With Cinacalcet

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Trial Comparing an Integrated Care Approach Using Electronic Cinacalcet Adherence Data Versus Usual Care to Improve Secondary Hyperparathyroidism in Hemodialysis Patients

Conditions
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Hyperparathyroidism, Chronic Kidney Disease

Intervention / Treatment
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* Other: Monitoring of drug adherence


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Intolerance to Cincalcet-HCL 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual care<br> | |
| Active Comparator: adherence intervention arm<br>Monitoring drug adherence to guide treatment | Other: Monitoring of drug adherence<br>* 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.<br>* Other names: Compliance monitoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change from baseline in cinacalcet dose at 6 months | (6-months dose - baseline dose)/ baseline dose % dose expressed in mg/d | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absolute change from baseline in iPTH at 6 months | 6-months iPTH - baseline iPTH iPTH (=intact parathyroid hormone), unit ng/l | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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compliance, dialysis, hyperparathyroidism