Treatment Adhesion in Dialysis Patients Treated With Cinacalcet

Chronic Kidney Disease Clinical Trial

— MEMS-cinac  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01573520
• Other study ID #: 268/09
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2012
• Last updated: January 28, 2016
• Start date: January 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2016
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperparathyroidism
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Michel Burnier

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No