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
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Drug: Cinacalcet
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 23
Study Start Date: May 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cinacalcet Drug: Cinacalcet
One sequence receives Cinacalcet 30mg /d for 7 days followed by placebo for 7 days
Placebo Comparator: Placebo Drug: Placebo
One sequence receives placebo for 7 days followed by Cinacalcet 30mg/d for 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250405

Locations
Canada, Quebec
Karine Marquis
Québec, Quebec, Canada, G1R2J6
Sponsors and Collaborators
Laval University
Amgen
Investigators
Principal Investigator: Mohsen Agharazii, MD Laval University
  More Information

No publications provided

Responsible Party: Karine Marquis, Professionnelle de recherche, Laval University
ClinicalTrials.gov Identifier: NCT01250405     History of Changes
Other Study ID Numbers: CA2009-0008
Study First Received: November 26, 2010
Last Updated: April 4, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on April 17, 2014