Clinical Trial Details
| Trial ID: | L0084 |
| Source ID: | NCT01879618 |
| Associated Drug: | Fragmin |
| Title: | Use Of Fragmin In Hemodialysis |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01879618/results |
| Conditions: | Chronic Renal Failure |
| Interventions: | DRUG: Fragmin |
| Outcome Measures: | Primary: 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., 20 HD sessions (up to 4 hours) | Secondary: 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., 20 HD sessions (up to 4 hours) |
| Sponsor/Collaborators: | Sponsor: Pfizer |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 152 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2013-10 |
| Completion Date: | 2016-03 |
| Results First Posted: | 2016-12-29 |
| Last Update Posted: | 2017-03-10 |
| Locations: | Royal Alexandra Hospital, Edmonton, Alberta, T5G 0B8, Canada|University of Alberta Hospital, Edmonton, Alberta, T6G 2B7, Canada|Grey Nuns Community Hospital, Edmonton, Alberta, T6L 5X8, Canada|Horizon Health Network/Saint John Regional Hospital, Saint John, New Brunswick, E2L 4L2, Canada|Eastern Regional Health Authority, Health Sciences Centre, St. John's, Newfoundland and Labrador, A1B 3V6, Canada|Eastern Regional Health Authority, St. Clare's Mercy Hospital, St. John's, Newfoundland and Labrador, A1C 5B8, Canada|Eastern Regional Health Authority, Waterford Hospital, St. John's, Newfoundland and Labrador, A1E 4J8, Canada|Queen Elizabeth II Health Sciences Center (QEII) - VG Site, Halifax, Nova Scotia, B3H 2Y9, Canada|William Osler Health System - Bramptom Civic Hospital, Brampton, Ontario, L6R 3J7, Canada|London Health Sciences Centre, University Hospital, London, Ontario, N6A 5A5, Canada|London Health Sciences Centre, Kidney Care Centre, London, Ontario, N6K 1M6, Canada|William Osler Health System, Orangeville, Ontario, L9W 4X9, Canada|Centre intégré de santé et de services sociaux de la Montérégie-Centre, Greenfield Park, Quebec, J4V 2H1, Canada|Centre externe de néphrologie CISSS de la Montérégie-Centre, Greenfield Park, Quebec, J4V 3M3, Canada|Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Saint-Luc, Montreal, Quebec, H2X 3J4, Canada|CIUSSS du Nord-de-l'Ile-de-Montreal, Montreal, Quebec, H3M 3E3, Canada|CIUSSS du Nord-de-l'Ile-de-Montreal, Montreal, Quebec, H4J 1C5, Canada|Centre externe de néphrologie CISSS de la Montérégie-Centre, Saint-Lambert, Quebec, J4R 2L1, Canada|CHU de Quebec (Pavillon Hotel-Dieu de Quebec), Quebec, G1R 2J6, Canada |
| URL: | https://clinicaltrials.gov/show/NCT01879618 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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