The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
7
150 mg capsule
75 mg capsule
110 mg capsule
1160.121.1 Boehringer Ingelheim Investigational Site
Berlin, Germany
Dialysis Clearance of Dabigatran
Dialysis clearance of dabigatran from blood (CLD,b) and dialysis clearance of dabigatran from plasma (CLD) were calculated and indicate how quickly dabigatran is cleared out from blood or plasma.
Time frame: 4 hours
Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis
Extent of dabigatran that is removed from blood during one complete 4-hour cycle of dialysis was computed by the difference of plasma concentration at the start and at the end of dialysis relative to the start concentration and is therefore measured as a percentage.
Time frame: 4 hours
Plasma Concentration Extraction Ratio
Plasma concentration extraction ratio was measured directly at the dialysis machine and computed as the difference of the predialysis plasma concentration and the postdialysis plasma concentration relative to the predialysis concentration on the percentage scale (minimum: 0 percent of extraction (worst), maximum: 100 percent of extraction).
Time frame: 4 hours
Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h)
Area under the concentration-time curve of total and free dabigatran in plasma over the time interval from 0 to 8 hours after the second and third administration of dabigatran.
Time frame: Days 2 and 3
Maximum Plasma Concentrations of Dabigatran (Cmax)
Maximum measured concentration of total and free dabigatran in plasma after the second and third administration of dabigatran.
Time frame: Days 2 and 3
Time to Maximum Plasma Concentration (Tmax)
Time to maximum plasma concentration of total and free dabigatran in plasma after the third administration of dabigatran.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 3
Coagulation Parameters
Assessment of blood coagulation parameters 'activated partial thromboplastin time' (aPTT) and 'factor IIa inhibition' (anti-FIIa) measured with the diluted thrombin time assay. Time to the formation of a fibrin clot (coagulation) is measured in seconds.
Time frame: Day 3
Safety and Tolerability
Tolerability refers to the number of non-tolerable patients as assessed through the subjective examination of adverse events (AE). Safety refers to the number of patients with treatment emergent AEs. These numbers are presented on the overall Dabigatran treatment.
Time frame: 2 periods of 5 days each
Additional Safety Parameters
By study design abnormalities could be due to dialysis or Dabigatran.
Time frame: 2 periods of 5 days each