Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Cardiovascular Diseases

Kidney Failure, Chronic

Treatments

Drug: Dabigatran etexilate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01241539

2010-021819-16 (EudraCT Number)

1160.121

Details and patient eligibility

About

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

Enrollment

7 patients

Sex

All

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

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