Treatment Adhesion in Dialysis Patients Treated With Cinacalcet

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.

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Key information

Conditions

Hyperparathyroidism Behavior Chronic Disease Chronic Kidney Disease Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Health Behavior Kidney Diseases Male Urogenital Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Renal Insufficiency Renal Insufficiency, Chronic Treatment Adherence and Compliance Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monitoring of drug adherence

Other

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 names: Compliance monitoring

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Michel Burnier

Other

Registry information

Official study title

A Randomized Trial Comparing an Integrated Care Approach Using Electronic Cinacalcet Adherence Data Versus Usual Care to Improve Secondary Hyperparathyroidism in Hemodialysis Patients

Acronym: MEMS-cinac

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Apr 9, 2012
Registry last updated: Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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