Chronic Kidney Disease, Hyperparathyroidism
Conditions
Keywords
compliance, dialysis, hyperparathyroidism
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.
Interventions
OTHERMonitoring 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.
Sponsors
Michel Burnier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change from baseline in cinacalcet dose at 6 months | baseline and 6 months | * (6-months dose - baseline dose)/ baseline dose % * dose expressed in mg/d |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| absolute change from baseline in iPTH at 6 months | baseline and 6 months | * 6-months iPTH - baseline iPTH * iPTH (=intact parathyroid hormone), unit ng/l |
Countries
Switzerland
Outcome results
None listed