Acute Effects of Cinacalcet on Arterial Stiffness and Ven... | NCT01250405

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

NCT01250405

Sponsor

Laval University

Status

Completed

Last Update Posted

Apr 7, 2014Estimated

Enrollment

23Actual

Phase

Phase 4

Conditions

Chronic Kidney Disease

Interventions

Cinacalcet
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Nov 26, 2010

First Submission Date that Met QC Criteria

Nov 29, 2010

First Posted Date

Nov 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2014

Last Update Posted Date

Apr 7, 2014Estimated

Name	Class
Amgen	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cinacalcet	Active Comparator		Drug: Cinacalcet
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cinacalcet	Drug	One sequence receives Cinacalcet 30mg /d for 7 days followed by placebo for 7 days	Cinacalcet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Arterial stiffness		Arterial stiffness with be measured after 1 week with placebo and after 1 week with cinacalcet

Secondary Outcomes

Measure	Description	Time Frame
Ventricular function		Ventricular function with be measured after 1 week with placebo and after 1 week with cinacalcet

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohsen Agharazii, MD	Laval University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karine Marquis		Québec	Quebec	G1R2J6	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28538380	Derived	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.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic