Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis

Open Label, Non Randomized, Multiple Dose Phase I Study to Investigate the Elimination, Pharmacokinetics, Pharmacodynamics and Safety of Dabigatran Etexilate (Pradaxa) Under Steady State Conditions Before, During and After Haemodialysis in Patients With End Stage Renal Disease (ESRD) Undergoing Regular Haemodialysis

The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.

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