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OpenTrials
Completed

NCT Number: NCT01250405

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Karine Marquis

Québec, Quebec, G1R2J6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cinacalcet

Drug

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

Placebo

Drug

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

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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Amgen

Registry information

Acronym: ECIRA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 30, 2010
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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