Back to resultsUse Of Fragmin In Hemodialysis
Primary Purpose
Chronic Renal Failure
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Fragmin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Renal Failure focused on measuring Fragmin, dalteparin, hemodialysis, anticoagulation, Renal Failure
Eligibility Criteria
Inclusion Criteria:
- chronic renal failure on hemodialysis
Exclusion Criteria:
- significant comorbidities that would prevent a patient from completing the trial
Sites / Locations
- Royal Alexandra Hospital
- University of Alberta Hospital
- Grey Nuns Community Hospital
- Horizon Health Network/Saint John Regional Hospital
- Eastern Regional Health Authority, Health Sciences Centre
- Eastern Regional Health Authority, St. Clare's Mercy Hospital
- Eastern Regional Health Authority, Waterford Hospital
- Queen Elizabeth II Health Sciences Center (QEII) - VG Site
- William Osler Health System - Bramptom Civic Hospital
- London Health Sciences Centre, University Hospital
- London Health Sciences Centre, Kidney Care Centre
- William Osler Health System
- Centre intégré de santé et de services sociaux de la Montérégie-Centre
- Centre externe de néphrologie CISSS de la Montérégie-Centre
- Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Saint-Luc
- CIUSSS du Nord-de-l'Ile-de-Montreal
- CIUSSS du Nord-de-l'Ile-de-Montreal
- Centre externe de néphrologie CISSS de la Montérégie-Centre
- CHU de Quebec (Pavillon Hotel-Dieu de Quebec)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fragmin
Arm Description
Fragmin given according to the flexible dosing regimen outlined in the protocol
Outcomes
Primary Outcome Measures
Mean Percent of Successful HD Sessions
A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant's blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data.
Secondary Outcome Measures
Mean Percent of HD Sessions With an Acceptable Dose
A HD session with an acceptable dose is defined in terms of efficacy of the drug: an HD session for which the dose at the next HD session did not need to be changed due to Grade 3 or 4 clotting, bleeding, access compression time > 10 minutes, or other clinical event. The point estimate and 95% CI were computed based on GEE model for clustered binomial.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01879618
Brief Title
Use Of Fragmin In Hemodialysis
Official Title
A Phase IIIb Open Label Study To Optimize The Single Bolus Dose Of Dalteparin Sodium For The Prevention Of Clotting Within The Extracorporeal System During Hemodialysis Procedures For Subjects With Chronic Renal Insufficiency: The Parrot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
Keywords
Fragmin, dalteparin, hemodialysis, anticoagulation, Renal Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fragmin
Arm Type
Experimental
Arm Description
Fragmin given according to the flexible dosing regimen outlined in the protocol
Intervention Type
Drug
Intervention Name(s)
Fragmin
Intervention Description
variable dosing regimen
Primary Outcome Measure Information:
Title
Mean Percent of Successful HD Sessions
Description
A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant's blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data.
Time Frame
20 HD sessions (up to 4 hours)
Secondary Outcome Measure Information:
Title
Mean Percent of HD Sessions With an Acceptable Dose
Description
A HD session with an acceptable dose is defined in terms of efficacy of the drug: an HD session for which the dose at the next HD session did not need to be changed due to Grade 3 or 4 clotting, bleeding, access compression time > 10 minutes, or other clinical event. The point estimate and 95% CI were computed based on GEE model for clustered binomial.
Time Frame
20 HD sessions (up to 4 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic renal failure on hemodialysis
Exclusion Criteria:
significant comorbidities that would prevent a patient from completing the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 0B8
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Grey Nuns Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
Horizon Health Network/Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Eastern Regional Health Authority, Health Sciences Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Eastern Regional Health Authority, St. Clare's Mercy Hospital
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 5B8
Country
Canada
Facility Name
Eastern Regional Health Authority, Waterford Hospital
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1E 4J8
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Center (QEII) - VG Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
William Osler Health System - Bramptom Civic Hospital
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
London Health Sciences Centre, University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
London Health Sciences Centre, Kidney Care Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6K 1M6
Country
Canada
Facility Name
William Osler Health System
City
Orangeville
State/Province
Ontario
ZIP/Postal Code
L9W 4X9
Country
Canada
Facility Name
Centre intégré de santé et de services sociaux de la Montérégie-Centre
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Centre externe de néphrologie CISSS de la Montérégie-Centre
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 3M3
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Saint-Luc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
CIUSSS du Nord-de-l'Ile-de-Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3M 3E3
Country
Canada
Facility Name
CIUSSS du Nord-de-l'Ile-de-Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Centre externe de néphrologie CISSS de la Montérégie-Centre
City
Saint-Lambert
State/Province
Quebec
ZIP/Postal Code
J4R 2L1
Country
Canada
Facility Name
CHU de Quebec (Pavillon Hotel-Dieu de Quebec)
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
30542622
Citation
Soroka S, Agharazii M, Donnelly S, Roy L, Muirhead N, Cournoyer S, MacKinnon M, Pannu N, Barrett B, Madore F, Tennankore K, Wilson JA, Hilton F, Sherman N, Wolter K, Orazem J, Feugere G. An Adjustable Dalteparin Sodium Dose Regimen for the Prevention of Clotting in the Extracorporeal Circuit in Hemodialysis: A Clinical Trial of Safety and Efficacy (the PARROT Study). Can J Kidney Health Dis. 2018 Nov 4;5:2054358118809104. doi: 10.1177/2054358118809104. eCollection 2018.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6301091&StudyName=Use%20Of%20Fragmin%20In%20Hemodialysis
Description
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Use Of Fragmin In Hemodialysis
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