Treatment Adhesion in Dialysis Patients Treated With Cinacalcet

NCT01573520 | Completed Phase 4

• 1 other identifier: 268/09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperparathyroidism; Chronic Kidney Disease

Keywords

compliance; dialysis; hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• Relative change from baseline in cinacalcet dose at 6 months

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

  baseline and 6 months

Secondary Outcomes (1)

• absolute change from baseline in iPTH at 6 months

  baseline and 6 months

Study Arms (2)

usual care

NO INTERVENTION

adherence intervention arm

ACTIVE COMPARATOR

Monitoring drug adherence to guide treatment

Other: Monitoring of drug adherence

Interventions

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.

Also known as: Compliance monitoring

adherence intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michel Burnier: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Hyperparathyroidism; Renal Insufficiency, Chronic; Patient Compliance

Condition Hierarchy (Ancestors)

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

Study Officials

• Michel Burnier, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Centre Hospitalier Universitaire Vaudois

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: April 9, 2012
• Study Start: January 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

CH (1)