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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cinacalcet

Group Type ACTIVE_COMPARATOR

Cinacalcet

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Cinacalcet

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No