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Use Of Fragmin In Hemodialysis

Last updated on November 15, 2019

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Study Location
Royal Alexandra Hospital
Edmonton, Alberta, T5G 0B8 Canada
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Renal Failure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- chronic renal failure on hemodialysis

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT01879618
Pfizer
Completed
Use Of Fragmin In Hemodialysis

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Descriptive Information
Brief Title  ICMJE Use Of Fragmin In Hemodialysis
Official Title  ICMJE 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
Brief SummaryThe study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Renal Failure
Intervention  ICMJE Drug: Fragmin
variable dosing regimen
Study Arms  ICMJE Experimental: Fragmin
Fragmin given according to the flexible dosing regimen outlined in the protocol
Intervention: Drug: Fragmin
Publications *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, Feugère 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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2016)
152
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2013)
150
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion DateMarch 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • chronic renal failure on hemodialysis

Exclusion Criteria:

  • significant comorbidities that would prevent a patient from completing the trial
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01879618
Other Study ID Numbers  ICMJE A6301091
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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