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

Chronic Kidney Disease Clinical Trial

— ECIRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250405
• Other study ID #: CA2009-0008
• Status: Completed
• Phase: Phase 4
• First received: November 26, 2010
• Last updated: April 4, 2014
• Start date: May 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Cinacalcet
One sequence receives Cinacalcet 30mg /d for 7 days followed by placebo for 7 days
• Placebo
One sequence receives placebo for 7 days followed by Cinacalcet 30mg/d for 7 days

Locations

Country	Name	City	State
Canada	Karine Marquis	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Amgen

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial stiffness		Arterial stiffness with be measured after 1 week with placebo and after 1 week with cinacalcet	No
Secondary	Ventricular function		Ventricular function with be measured after 1 week with placebo and after 1 week with cinacalcet	No