Chronic Kidney Disease
Conditions
Brief summary
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.
Interventions
DRUGCinacalcet
One sequence receives Cinacalcet 30mg /d for 7 days followed by placebo for 7 days
DRUGPlacebo
One sequence receives placebo for 7 days followed by Cinacalcet 30mg/d for 7 days
Sponsors
Amgen
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Arterial stiffness | Arterial stiffness with be measured after 1 week with placebo and after 1 week with cinacalcet |
Secondary
| Measure | Time frame |
|---|---|
| Ventricular function | Ventricular function with be measured after 1 week with placebo and after 1 week with cinacalcet |
Countries
Canada
Outcome results
None listed