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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 29, 2014