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CompletedNCT01250405ECIRAUpdated Apr 7, 2014

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

A Phase 4 interventional study of Cinacalcet and Placebo in Chronic Kidney Disease, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-04-07.

Sponsored by Laval University · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 23 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
23 participants (actual)

Study arms

  • Active comparator
    Cinacalcet

    Drug: Cinacalcet

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugCinacalcet

    One sequence receives Cinacalcet 30mg /d for 7 days followed by placebo for 7 days

  • DrugPlacebo

    One sequence receives placebo for 7 days followed by Cinacalcet 30mg/d for 7 days

06

What researchers measure

Primary outcomes

  1. Arterial stiffness

    Time frame: Arterial stiffness with be measured after 1 week with placebo and after 1 week with cinacalcet

Secondary outcomes

  1. Ventricular function

    Time frame: Ventricular function with be measured after 1 week with placebo and after 1 week with cinacalcet

07

Study locations

1 site
  • Karine Marquis
    Québec, Quebec G1R2J6, Canada
08

References and documents

Publications

  • Poulin A, Bellemare PL, Fortier C, Mac-Way F, Desmeules S, Marquis K, Gaudreault V, Lebel M, Agharazii M. Acute effects of cinacalcet on arterial stiffness and ventricular function in hemodialysis patients: A randomized double-blinded crossover study. Medicine (Baltimore). 2017 May;96(21):e6912. doi: 10.1097/MD.0000000000006912. PubMed 28538380 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01250405
Lead sponsor
Laval University
Collaborators
Amgen
Responsible party
Karine Marquis (Professionnelle de recherche, Laval University) — Principal investigator
First posted
Nov 30, 2010
Start date
May 2012
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Apr 7, 2014

Study contacts

Mohsen Agharazii, MD
principal investigator · Laval University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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