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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01879618
Other study ID # A6301091
Secondary ID
Status Completed
Phase Phase 3
First received June 13, 2013
Last updated April 2, 2016
Start date October 2013
Est. completion date March 2016

Study information

Verified date April 2016
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.


Recruitment information / eligibility

Status Completed
Enrollment 153
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- chronic renal failure on hemodialysis

Exclusion Criteria:

- significant comorbidities that would prevent a patient from completing the trial

Study Design

Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Fragmin
variable dosing regimen

Locations

Country Name City State
Canada William Osler Health System - Bramptom Civic Hospital Brampton Ontario
Canada Grey Nuns Community Hospital Edmonton Alberta
Canada Royal Alexandra Hospital Edmonton Alberta
Canada University of Alberta Hospital Edmonton Alberta
Canada Centre externe de néphrologie CISSS de la Montérégie-Centre Greenfield Park Quebec
Canada Centre intégré de santé et de services sociaux de la Montérégie-Centre Greenfield Park Quebec
Canada Queen Elizabeth II Health Sciences Center (QEII) - VG Site Halifax Nova Scotia
Canada London Health Sciences Centre, Kidney Care Centre London Ontario
Canada London Health Sciences Centre, University Hospital London Ontario
Canada Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Saint-Luc Montreal Quebec
Canada CIUSSS du Nord-de-l'Ile-de-Montreal Montreal Quebec
Canada CIUSSS du Nord-de-l'Ile-de-Montreal Montreal Quebec
Canada William Osler Health System Orangeville Ontario
Canada CHU de Quebec Quebec
Canada Horizon Health Network/Saint John Regional Hospital Saint John New Brunswick
Canada Centre externe de néphrologie CISSS de la Montérégie-Centre Saint-Lambert Quebec
Canada Eastern Regional Health Authority, Health Sciences Centre St. John's Newfoundland and Labrador
Canada Eastern Regional Health Authority, St. Clare's Mercy Hospital St. John's Newfoundland and Labrador
Canada Eastern Regional Health Authority, Waterford Hospital St. John's Newfoundland and Labrador

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clotting in Dialyzer Clotting in Dialyzer 0-4 hours No
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