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

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Karine Marquis, Laval University
ClinicalTrials.gov Identifier:
NCT01250405
First received: November 26, 2010
Last updated: April 4, 2014
Last verified: April 2014

November 26, 2010
April 4, 2014
May 2012
April 2014   (final data collection date for primary outcome measure)
Arterial stiffness [ Time Frame: Arterial stiffness with be measured after 1 week with placebo and after 1 week with cinacalcet ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01250405 on ClinicalTrials.gov Archive Site
Ventricular function [ Time Frame: Ventricular function with be measured after 1 week with placebo and after 1 week with cinacalcet ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients
Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Chronic Kidney Disease
  • Drug: Cinacalcet
    One sequence receives Cinacalcet 30mg /d for 7 days followed by placebo for 7 days
  • Drug: Placebo
    One sequence receives placebo for 7 days followed by Cinacalcet 30mg/d for 7 days
  • Active Comparator: Cinacalcet
    Intervention: Drug: Cinacalcet
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01250405
CA2009-0008
No
Karine Marquis, Laval University
Laval University
Amgen
Principal Investigator: Mohsen Agharazii, MD Laval University
Laval University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP