Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients (ECIRA)

Laval University

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Drug: Cinacalcet; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01250405

CA2009-0008

Details and patient eligibility

About

The primary objective is to determine whether reduction of serum calcium concentration by cinacalcet leads to reduction of mean blood pressure adjusted c-fPWV. The secondary objectives are to study the effects of calcium reduction on 1) carotid-radial PWV (c-rPWV), 2) common carotid artery (CCA) biomechanics, 3) pulse wave profile and cardiac function.

Enrollment: 23 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic (> 3 months) hemodialysis population of > 18 years old
• PTH > 300 ng/L
• corrected Ca > 2.10 mmol/L
• stable hypertensive drugs (> 1 month)
• stable doses of phosphate binders and dialysis calcium concentration
• palpable femoral pulse
• systolic BP of 90-180 mmHg
• expected survival of > 6 months

Exclusion criteria

• hemodialysis > 3 years
• acute infection
• history of myocardial infarction or stroke within the past 3 months
• inability to consent
• intolerance to cinacalcet
• inadequate birth control

Trial design

23 participants in 2 patient groups, including a placebo group

Cinacalcet

Active Comparator group

Treatment:

Drug: Cinacalcet

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo