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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Centre Hospitalier Universitaire Vaudois.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Michel Burnier, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01573520
First received: March 23, 2012
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Hyperparathyroidism
Dialysis
Other: Monitoring of drug adherence
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Relative change from baseline in cinacalcet dose at 6 months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    • (6-months dose - baseline dose)/ baseline dose %
    • dose expressed in mg/d


Secondary Outcome Measures:
  • absolute change from baseline in iPTH at 6 months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    • 6-months iPTH - baseline iPTH
    • iPTH (=intact parathyroid hormone), unit ng/l


Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573520

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Michel Burnier
Investigators
Principal Investigator: Michel Burnier, MD Centre Hospitalier Universitaire Vaudois
  More Information

No publications provided

Responsible Party: Michel Burnier, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01573520     History of Changes
Other Study ID Numbers: 268/09
Study First Received: March 23, 2012
Last Updated: April 5, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Centre Hospitalier Universitaire Vaudois:
compliance
dialysis
hyperparathyroidism

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 26, 2014