Treatment Adhesion in Dialysis Patients Treated With Cinacalcet

Phase 4

Completed

• Conditions: Chronic Kidney Disease; Hyperparathyroidism
• Interventions: Other: Monitoring of drug adherence

• Registration Number: NCT01573520
• Lead Sponsor: Michel Burnier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-04-05
• Study First Posted: 2012-04-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
adherence intervention arm	Monitoring of drug adherence	Monitoring drug adherence to guide treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland