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Treatment Adhesion in Dialysis Patients Treated With Cinacalcet (MEMS-cinac)

Primary Purpose

Hyperparathyroidism, Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Monitoring of drug adherence
Sponsored by
Michel Burnier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperparathyroidism focused on measuring compliance, dialysis, hyperparathyroidism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

usual care

adherence intervention arm

Arm Description

Monitoring drug adherence to guide treatment

Outcomes

Primary Outcome Measures

Relative change from baseline in cinacalcet dose at 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
6-months iPTH - baseline iPTH iPTH (=intact parathyroid hormone), unit ng/l

Full Information

First Posted
March 23, 2012
Last Updated
January 28, 2016
Sponsor
Michel Burnier
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1. Study Identification

Unique Protocol Identification Number
NCT01573520
Brief Title
Treatment Adhesion in Dialysis Patients Treated With Cinacalcet
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michel Burnier

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Chronic Kidney Disease
Keywords
compliance, dialysis, hyperparathyroidism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual care
Arm Type
No Intervention
Arm Title
adherence intervention arm
Arm Type
Active Comparator
Arm Description
Monitoring drug adherence to guide treatment
Intervention Type
Other
Intervention Name(s)
Monitoring of drug adherence
Other Intervention Name(s)
Compliance monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relative change from baseline in cinacalcet dose at 6 months
Description
(6-months dose - baseline dose)/ baseline dose % dose expressed in mg/d
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
absolute change from baseline in iPTH at 6 months
Description
6-months iPTH - baseline iPTH iPTH (=intact parathyroid hormone), unit ng/l
Time Frame
baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Burnier, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

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Treatment Adhesion in Dialysis Patients Treated With Cinacalcet

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