Clinical Trial Details
| Trial ID: | L0117 |
| Source ID: | NCT04006093 |
| Associated Drug: | Apixaban Oral |
| Title: | Apixaban in Subjects With Peritoneal Dialysis |
| Acronym: | ApiDP |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Renal Insufficiency|Peritoneal Dialysis |
| Interventions: | DRUG: Apixaban Oral |
| Outcome Measures: | Primary: Apixaban area Under the curve, Measurement of apixaban plasma concentrations at different times., Day 3|Apixaban maximum plasma concentration, Measurement of apixaban plasma concentrations at different times., Day 3 | Secondary: anti-Xa activity, anti-Xa activity plasma measurements, Hour 0, Hour 3, Hour 9 and Hour 72|TP activity, TP activity plasma measurements, Hour 0, Hour 3, Hour 9 and Hour 72|TCA activity, TCA activity plasma measurements, Hour 0, Hour 3, Hour 9 and Hour 72|Apixaban urinary elimination, Measurement of apixaban urinary concentrations, Day 3|Apixaban maximum peritoneal concentration, Measurement of apixaban peritoneal fluid concentrations, day 3 |
| Sponsor/Collaborators: | Sponsor: University Hospital, Caen | Collaborators: University Hospital, Rouen |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 24 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER |
| Start Date: | 2019-12-08 |
| Completion Date: | 2022-12-10 |
| Results First Posted: | |
| Last Update Posted: | 2023-01-20 |
| Locations: | CHU Caen, Caen, 14000, France |
| URL: | https://clinicaltrials.gov/show/NCT04006093 |
