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

Michel Burnier

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease; Hyperparathyroidism

Treatments: Other: Monitoring of drug adherence

Study type: Interventional

Funder types: Other

Identifiers

NCT01573520

268/09

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

usual care

No Intervention group

adherence intervention arm

Active Comparator group

Description:

Monitoring drug adherence to guide treatment

Treatment:

Other: Monitoring of drug adherence