| Trial ID: | L0105 |
| Source ID: | NCT02047006
|
| Associated Drug: |
Rivaroxaban 10 Mg
|
| Title: |
Dose-finding of Rivaroxaban in Hemodialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Renal Failure
|
| Interventions: |
DRUG: Rivaroxaban 10 mg
|
| Outcome Measures: |
Primary: Pharmacokinetics and pharmacodynamics of rivaroxaban in hemodialysis patients, 1. To measure the AUC and Cmax of 10 mg rivaroxaban in hemodialysis patients 2. To assess the effect of 10 mg rivaroxaban on coagulation assays in hemodialysis patients: * anti-Xa assay * prothrombin assay, AUC for 48 hours | Secondary: Dialytic removal of rivaroxaban, To assess the effect of a single dialysis session on plasma levels of rivaroxaban and on anti-Xa levels, 4 hours|Safety and tolerability of rivaroxaban in hemodialysis patients, Subjective tolerability is evaluated by questioning the patients about any adverse events or by spontaneous reporting of adverse events. Objective tolerability is evaluated by monitoring vital signs and routine clinical laboratory tests., 2 weeks
|
| Sponsor/Collaborators: |
Sponsor: AZ Sint-Jan AV | Collaborators: Onze Lieve Vrouw Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
18
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-09
|
| Completion Date: |
2014-10
|
| Results First Posted: |
|
| Last Update Posted: |
2015-01-14
|
| Locations: |
OLV Aalst, Aalst, 9300, Belgium|AZ Sint-Jan Brugge-Oostende AV, Brugge, 8000, Belgium
|
| URL: |
https://clinicaltrials.gov/show/NCT02047006
|
