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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01573520
Recruitment Status : Completed
First Posted : April 9, 2012
Last Update Posted : January 29, 2016
Information provided by (Responsible Party):
Michel Burnier, Centre Hospitalier Universitaire Vaudois

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

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Study Type : Interventional  (Clinical Trial)
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 : January 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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 Name: Compliance monitoring

Primary Outcome Measures :
  1. Relative change from baseline in cinacalcet dose at 6 months [ Time Frame: baseline and 6 months ]
    • (6-months dose - baseline dose)/ baseline dose %
    • dose expressed in mg/d

Secondary Outcome Measures :
  1. absolute change from baseline in iPTH at 6 months [ Time Frame: baseline and 6 months ]
    • 6-months iPTH - baseline iPTH
    • iPTH (=intact parathyroid hormone), unit ng/l

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01573520

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Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Michel Burnier
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Principal Investigator: Michel Burnier, MD Centre Hospitalier Universitaire Vaudois
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Responsible Party: Michel Burnier, Centre Hospitalier Universitaire Vaudois Identifier: NCT01573520    
Other Study ID Numbers: 268/09
First Posted: April 9, 2012    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016
Keywords provided by Michel Burnier, Centre Hospitalier Universitaire Vaudois:
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases