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

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ClinicalTrials.gov Identifier: NCT01250405
Recruitment Status : Completed
First Posted : November 30, 2010
Last Update Posted : April 7, 2014
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Karine Marquis, Laval University

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Cinacalcet Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients
Study Start Date : May 2012
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Arterial stiffness [ Time Frame: Arterial stiffness with be measured after 1 week with placebo and after 1 week with cinacalcet ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01250405


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karine Marquis, Professionnelle de recherche, Laval University
ClinicalTrials.gov Identifier: NCT01250405     History of Changes
Other Study ID Numbers: CA2009-0008
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs