Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran

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