Phase 1
Completed N=7
Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis
Cardiovascular Disease · Kidney Failure, Chronic
Source: ClinicalTrials.gov NCT01241539 ↗
Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcomePrimary: Dialysis Clearance of Dabigatran — 161; 241; 120; 183 mL/min
Summary
The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dialysis Clearance of Dabigatran |
161; 241; 120; 183; 167; 251 | — |
| PRIMARY Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis |
48.8; 59.3; 49.7; 59.3 | — |
| PRIMARY Plasma Concentration Extraction Ratio |
79.9; 61.4; 82.6; 63.7 | — |
| SECONDARY Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h) |
1230; 1140; 1280; 1180; 907; 802 | — |
| SECONDARY Maximum Plasma Concentrations of Dabigatran (Cmax) |
194; 171; 176; 159; 150; 126 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) |
1.49; 2.13; 1.35; 1.83 | — |
| SECONDARY Coagulation Parameters |
46.91; 44.26; 43.27; 43.09 | — |
| SECONDARY Safety and Tolerability |
2; 0 | — |
| SECONDARY Additional Safety Parameters |
0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
- End stage renally disease (ESRD), undergoing haemodialysis
- ESRD patients in relatively good health
- Age 21 - 60 years inclusive
- Signed and dated written informed consent prior to admission to the study
Exclusion criteria
- Clinically relevant laboratory or physical examination abnormalities (except for renal function tests or deviation of clinical laboratory values) that are related to renal impairment
- Moderate and severe concurrent liver function impairment
- Surgery of gastrointestinal tract (except appendectomy or herniotomy) or evidence of significant gastrointestinal motility problems
- Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding
- Intake of medication, which influences the blood clotting
- Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- For women with childbearing potential: no reliable contraception
- Participation in another trial with an investigational drug (<2 months prior to administration or during trial)
- Scheduled to receive a donor kidney transplant during the course of the study
Data sourced from ClinicalTrials.gov (NCT01241539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.