Treatment Adhesion in Dialysis Patients Treated With Cinacalcet

Michel Burnier50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperparathyroidism Chronic Kidney Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Relative change from baseline in cinacalcet dose at 6 months

* (6-months dose - baseline dose)/ baseline dose % * dose expressed in mg/d

Time frame: baseline and 6 months

Secondary Outcomes

absolute change from baseline in iPTH at 6 months

* 6-months iPTH - baseline iPTH * iPTH (=intact parathyroid hormone), unit ng/l