| Trial ID: | L1462 |
| Source ID: | NCT03456648
|
| Associated Drug: |
Apixaban
|
| Title: |
Apixaban in End-stage Kidney Disease : A Pharmacokinetics Study
|
| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
ESRD|Anticoagulant Toxicity
|
| Interventions: |
DRUG: apixaban
|
| Outcome Measures: |
Primary: AUC0-T apixaban, Anti-Xa activity values (IIU/mL) will be converted to apixaban concentration data (ng/mL) based on the previously demonstrated linear relationship (e.g. Frost et al., 2014 - PMID: 24697979). The area under the curve (AUC) between administration (time 0) and the last measurable data point (AUC0-T) will be calculated with the 'Lin up/Log down' trapezoidal method. The AUCT-∞ will be obtained from the last measureable concentration divided by λ, and will be summed with AUC0-T to obtain AUC0-∞ (total exposure). the slope (λ) of the terminal phase of the concentration-time profile will be determined by log-linear regression on the appropriate number (typically at least 3) of data points. The terminal (elimination) half-life (t1/2, λ) will be calculated from Ln(2)/λ., 48 hours|Cmax, Apixaban concentration-time profiles will be generated and observed values for the descriptive PK parameter Cmax (peak plasma concentration) will be determined directly from the time-concentration curve, 48 hours|Tmax, Apixaban concentration-time profiles will be generated and observed values for the descriptive PK parameter time to Cmax (Tmax)) will be determined directly from the time-concentration curve, 48 hours | Secondary: Occurrence of SAE, Occurrence of serious adverse events (SAE) will be analyzed as an important safety variable, 48 hours
|
| Sponsor/Collaborators: |
Sponsor: Universitaire Ziekenhuizen KU Leuven | Collaborators: Bristol-Myers Squibb
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-09-25
|
| Completion Date: |
2018-08-24
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| Results First Posted: |
|
| Last Update Posted: |
2018-10-17
|
| Locations: |
University Hospitals Leuven, Leuven, Vlaams-brabant, 3000, Belgium
|
| URL: |
https://clinicaltrials.gov/show/NCT03456648
|
