Chronic Renal Failure Clinical Trial
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"
| Verified date | April 2016 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.
| 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 |
Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clotting in Dialyzer | Clotting in Dialyzer | 0-4 hours | No |
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