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

This study has been completed.
Information provided by (Responsible Party):
Karine Marquis, Laval University Identifier:
First received: November 26, 2010
Last updated: April 4, 2014
Last verified: April 2014
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
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, 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 Karine Marquis, 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 ]

Secondary Outcome Measures:
  • Ventricular function [ Time Frame: Ventricular function with be measured after 1 week with placebo and after 1 week with cinacalcet ]

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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01250405

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

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

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 25, 2017