Status:
COMPLETED
Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Cardiovascular Diseases
Kidney Failure, Chronic
Eligibility:
All Genders
21-60 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01241539
Start Date
November 1 2010
Last Update
April 7 2014
Active Locations (1)
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1
1160.121.1 Boehringer Ingelheim Investigational Site
Berlin, Germany